Oncolytics Biotech heute TOP PERFORMER - 500 Beiträge pro Seite

[js200]

3:46pm ET
1.65
0.62 (60.19%)
Day`s Range: 1.12 - 1.74
Day`s Volume: 627,300
Avg. Volume: 10,038

JS200

[js200]

Oncolytics Biotech Inc. Reports Presentation of Results From Interim Assessment of T2 Prostate Cancer Trial
31 Mar 2003, 08:30am ET
E-mail or Print this story
- - - - -

CALGARY, March 31 /CNW/ - Oncolytics Biotech Inc. (TSX: ONC,
NASDAQ: ONCY) (`Oncolytics`) reports that Dr. Don Morris of the Alberta Cancer
Board and the University of Calgary presented results from an interim
assessment of the first six completed patients of a clinical study to evaluate
the efficacy and safety of REOLYSIN(R) for the treatment of T2 prostate
cancer. There was evidence of viral activity in five of six patients and there
were no safety concerns, from either a clinical or histopathological
perspective, in all six patients. The results were presented March 28th, 2003
at a conference on "Oncolytic Viruses As Cancer Therapeutics" held in Banff,
Alberta.
The preliminary data showed clear histopathological evidence of apoptotic
tumour cell death, one measure of viral activity, in four of the six patients.
In a fifth patient, the PSA level dropped by 53% and the prostate gland shrank
by 67% from just prior to treatment to the time of surgical removal. There was
no evidence of viral activity in the sixth patient. In all six patients, there
was no histopathological evidence of any viral effect on healthy prostatic
tissue.
"We are pleased with the preliminary results from this trial," said Dr.
Brad Thompson, Oncolytics` President and CEO. "This preliminary data shows
histopathological evidence that REOLYSIN(R) selectively infects and kills
tumour cells in humans. Our future clinical trials will examine systemic
administration of REOLYSIN(R) that will target metastatic disease. Advanced
prostate cancer will be considered for one of these trials."
The T2 prostate cancer trial is intended to evaluate the
histopathological efficacy of intra-tumoural administration of REOLYSIN(R) for
the treatment of cancer that is restricted to the prostate gland. Patients
will receive a single injection of REOLYSIN(R) and will be monitored for
approximately three weeks, at which time the prostate will be surgically
removed. The primary efficacy endpoint will be the response rate as measured
by pathological examination of the tumour.
Cancer of the prostate is one of the most common cancers in men,
representing approximately one-third of all male cancers in western society.
It is second only to lung cancer as the leading cause of cancer deaths in men.
There were an estimated 18,200 new cases of prostate cancer in Canada in 2002
and the American Cancer Society estimates that there will be 220,900 new cases
in the US in 2003.

About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the
development of REOLYSIN(R), its proprietary formulation of the human reovirus,
as a potential cancer therapeutic. Oncolytics` researchers have demonstrated
that the reovirus is able to selectively kill human cancer cells in vitro that
are derived from many types of cancer, including breast, prostate, pancreatic
and brain tumours, and have also demonstrated successful cancer treatment
results in a number of animal models. Phase I clinical trial results have
indicated that REOLYSIN(R) was well tolerated and that the reovirus
demonstrated activity in tumours injected with REOLYSIN(R).

This news release contains forward looking statements, within the meaning
of Section 21E of the Securities Exchange Act of 1934, as amended. Forward
looking statements, including the Company`s belief as to: the Company`s
expectations as to the safety and efficacy of REOLYSIN(R) including
application by systemic delivery; and the Company`s expectations as to the
design, timing and success of its planned clinical trial programs, involve
known and unknown risks and uncertainties, which could cause the Company`s
actual results to differ materially from those in the forward looking
statements. Such risks and uncertainties include, among others, the efficacy
of REOLYSIN(R) as a cancer treatment, the success and timely completion of
clinical studies and trials, uncertainties related to the research and
development of pharmaceuticals, uncertainties related to the regulatory
process and general changes to the economic environment. Investors should
consult the Company`s quarterly and annual filings with the Canadian and U.S.
securities commissions for additional information on risks and uncertainties
relating to the forward looking statements. Investors are cautioned against
placing undue reliance on forward looking statements. The Company does not
undertake to update these forward looking statements.


VIEW ADDITIONAL COMPANY-SPECIFIC INFORMATION:
http://www.newswire.ca/cgi-bin/inquiry.cgi?OKEY=56839


/For further information: For Canada: Oncolytics Biotech Inc., Brad
Thompson, 210, 1167 Kensington Cr NW, Calgary, Alberta T2N 1X7, Tel:
[phone], Fax: [phone], info(at)oncolyticsbiotech.com; For
Canada: The Equicom Group Inc., Joanna Longo, 20 Toronto Street, Toronto,
Ontario M5C 2B8, Tel: [phone] ext. 233, Fax: [phone],
jlongo(at)equicomgroup.com; For United States: The Investor Relations Group,
Gino De Jesus or Dian Griesel, Ph.D., 50 Pine Street, 6th Floor, New York, NY
10005, Tel: [phone], Fax: [phone], theproteam(at)aol.com/


JS200

[Bombenleger]

Js200,

warum machst du einen extra neuen thread dewegen auf?
habe einen.steht alles drin.

[js200]

05/02/2003 (11:06 ET) VOLUME(-): ONCY Volume 15% > 20-adsv, Stock -5.00% - Knobias
05/01/2003 (09:51 ET) VOLUME(-): ONCY Volume 18% > 20-adsv, Stock -5.66% - Knobias
04/30/2003 (11:25 ET) MOVER(+): ONCY Sharply Higher on Strong Volume - Knobias
04/30/2003 (10:02 ET) VOLUME(+): ONCY Volume 522% > 20-adsv, Stock +10.68% - Knobias
04/08/2003 (11:22 ET) New 6-K just released for ONCY - Edgar

JS200

[merx]

Hi,

der Annual report aktuell:

http://sedarfiles.stockwatch.com/sedar/viewsedardoc.asp?doci…


Gruß

merx

[js200]

Vom Freitag

ONCY
ONCOLYTICS BIOTECH INC
1.400
0.000 0.00%


Daily Commentary
HOLD

Our system recommends HOLD as of today. Previous BUY recommendation was made on 5/1/2003 (1) days ago, when the stock price was 1.400. Since then the stock gained 0.00% .

Today the stock closed unchanged with a lower high and a lower low. The volume is extremely high. The security price is trending up.

Candlestick Analysis

Today’s Candlestick Patterns:
Long Black Candlestick

Today a Long Black Candlestick formed. Sellers were aggressive and selling pressure was strong. Be careful, this may be a potential turning point!

Stock Quote
Last 1.400
Previous Close 1.400
Change 0.000
% Change 0.00%
Volume 136,800
Stock Activity
Open 1.470
Day`s High 1.470
Day`s Low 1.260
52 Week High 1.930
52 Week Low 0.980

Stock Price History
3 Month % Change 16.67
6 Month % Change 27.27
12 Month % Change -27.08
Stock Statistics
50 Day Close MA 1.118
200 Day Close MA 1.243
65 Day Volume MA 25,387

JS200

[muycaro]

Sollte sich jeder mal anschauen:

http://www.canada.com/calgary/story.asp?id=76E708D5-FD1C-48B…

[muycaro]

Nochwas von CEOCast:

Speaking of break-out volume, Oncolytics Biotech (NASDAQ: ONCY), a thinly-traded Canadian biopharmaceutical concern, surged 35% in price this week on explosive volume. The company has had no news for over one month, but somebody appears to want to accumulate a position very badly. The stock jumped 56% on Wednesday on record volume. We believe investors may finally be recognizing the potential of the company’s REOLYISIN® platform, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. We could learn more about the spike in volume soon, as the company is expected to announce first quarter results within the next two weeks. The stock ended the week at $1.40. (U.S.)

[muycaro]

Heute mal wieder knapp 30% im Plus, mit knapp 1Mio gehandelten Stücken, was ca. dem 10-20fachen des üblichen Handelsvolumens entspricht - geht doch für den Anfang.

Nasdaq:
http://finance.yahoo.com/q?s=ONCY&d=c&k=c1&t=5d&l=on&z=m&q=l

Toronto:
http://www.stockhouse.ca/comp_info.asp?symbol=ONC&table=list

Orderbuch Archipelago/Island:
http://www.archipelago.com/automm2/popup_arca_book_lim.asp?b…

Mal sehen wie das morgen weitergeht, scheinen ja täglich mehr Leute das Potential zu erahnen was hier drin steckt.

[js200]

VOLUME(+): ONCY Volume 14% > 20-adsv, Stock +7.14%

Monday , May 05, 2003 10:48 ET

This is the 4th VOLUME alert for ONCY in the past 7 calendar days.

Trading for Oncolytics Biotechnology, Incorporated (NASDAQ SC: ONCY) has been heavier than usual in today`s session. By 10:45 ET, the stock had already traded 69,600 shares via 79 trades. The cumulative volume is 13.74% above its 20-day average of 61,193. Normally the stock experiences around 71 individual trades per session.

So far, today`s volume surge has caused a net rise in ONCY`s stock price. At the time of this alert, the stock was trading at $1.500, up $0.100 (+7.14%).

One year ago, the Company`s shares closed at $1.810. The price has declined more than 17 percent since then.

Over the last 10 trading session ONCY has traded in a range between $1.000 and $1.740 and is currently trading 30.23% below its 52-week high of $2.150 set on January 06, 2003 and 64.84% above its 52-week low of $0.910 from October 28, 2002.

In the previous 3 sessions, ONCY trading has displayed a mixed trend. Closing results have been as follows:

May 02, 2003 --- closed at $1.400 even for the day on 136,800 shares
May 01, 2003 --- closed at $1.400 down $0.190 (-11.95%) on 270,200 shares
April 30, 2003 --- closed at $1.590 up $0.560 (+54.37%) on 722,900 shares

The Company last released news on March 31, 2003:

"Oncolytics Biotech Inc. Reports Presentation of Results From Interim Assessment of T2 Prostate Cancer Trial"

ONCOLYTICS BIOTECHNOLOGY, INCORPORATED
Oncolytics Biotechnology, Inc. is in the development stage. Oncolytics Biotech, Inc. is a biotechnology company formed to develop the reovirus as a potential therapeutic for a wide variety of human cancers that have not been successfully treated with conventional therapeutics. The majority of the activities of Oncolytics Biotech, Inc. are conducted under contract with third party service providers. Oncolytics Biotech, Inc. does not expect to generate significant revenues until its cancer product REOLYSIN becomes commercially viable and is assessing its options for production, marketing, sales and distribution of this product.

JS200

[muycaro]

Press Release Source: Oncolytics Biotech Inc.

Oncolytics Biotech Inc. Reports Enrollment Has Resumed In Phase I Malignant Glioma Study
Wednesday May 7, 8:31 am ET

CALGARY, May 7 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) (`Oncolytics`) today announced that enrollment has resumed in the Phase I component of its clinical study examining the use of REOLYSIN® in the treatment of recurrent malignant glioma, the most aggressive form of brain cancer.

Changes to the clinical protocol were suggested by an independent data safety monitoring board, the study investigators, and Oncolytics to enhance the measurement of the safety and efficacy of REOLYSIN® in the intended patient population in future studies. These changes have now been reviewed and approved by Health Canada.

Determination of the safety of REOLYSIN® is the primary purpose of the Phase I study. The study is examining the use of a single, intratumoural injection of REOLYSIN®, delivered using imaging-guided surgery, in patients with malignant glioma that has recurred despite other treatments, including surgery and radiation therapy. After treatment with REOLYSIN®, the Phase I patients are monitored and evaluated for safety for a period of six months. The Company previously reported that REOLYSIN® appeared to be well tolerated when surgically delivered into the brain during the treatment of the first six patients enrolled in the study. Four of the six treated patients were alive at the conclusion of their six-month safety follow-ups. Three of these four patients continue to be followed with survival times currently ranging between 7 and 10 months post-treatment.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill human cancer cells in vitro that are derived from many types of cancer, including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

This news release contains forward looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements, including the Company`s belief as to the Company`s expectations as to the safety and efficacy of REOLYSIN® including application by systemic delivery and anticipated result of the Phase I study; the Company`s expectations as to the design, timing and success of its planned clinical trial programs, including the anticipated enrollment and commencement of the Phase II study; the primary purpose of the Phase I study and its evaluation of the intended patient population for REOLYSIN® in future studies and other statements related to anticipated developments in the Company`s business and technologies, all of which involve known and unknown risks and uncertainties that could cause the Company`s actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward looking statements. The Company does not undertake to update these forward looking statements.


http://biz.yahoo.com/prnews/030507/to275_1.html

[muycaro]

Cancer drug trial extended

David Heyman
Calgary Herald

Wednesday, May 07, 2003

A Calgary biotech company will enrol at least six more patients in a clinical brain cancer trial to test the safety of its virus-based drug that has already shown tremendous promise.

Oncolytics Biotech Inc. said Tuesday it has received the go-ahead from Health Canada to continue, with some protocol amendments, its Phase I trial that had been put on hold while the agency evaluated the safety of Reolysin. But the results indicate not only that it is safe but that even minute doses may help extend the lives of people stricken with brain cancer, which is particularly aggressive and lethal.

Of the first six patients in the Phase 1 trial, four survived far beyond the three-month life expectancy they had been given when they got a single dose of Reolysin. Of those four, three are still alive, including one who has lived for nearly 10 months.

One of the patients enrolled was Calgarian Joan Lisoway, 58, the first person to enter the trial and who died April 18. The identities of the other patients have not been revealed.

The results have surprised even Oncolytics brass who were not prepared to track patients so long after their injections.

"There was nothing in our protocol to do anything after six months," said Matt Coffey, Oncolytics vice-president of product development.

"It`s early, but it looks encouraging."

The company has spent this week fielding calls from all over North America and managers are now planning for a subsequent Phase 2 trial, to start possibly by the end of the year, that will focus more on how their product Reolysin can begin to save lives.

Furthermore, Oncolytics wants scientists around the world to work with Reolysin in various ways. This would not only help spread the word of their success among the scientific community, but take some of the workload off local researchers.

Health Canada has permitted Oncolytics to proceed with the current Phase 1 trial, but has asked the company to focus only on a specific kind of brain cancer called recurrent primary glioblastoma multiforme.

Patients in the current Phase 1 brain cancer trail must have had at least one to three recurrences of the disease and have tried radiotherapy among other conditions.

The point of the Phase 1 trial is to make sure the drug is not toxic, so the initial patients were given very low doses. The first three patients, for example, were given amounts a tenth of what individual mice got in a previous animal trial. The second three got the same sized dose as the mice.

For the next group of patients, the dose will be escalated by the same factor of 10 until there are signs the drug is becoming toxic.

Once that level has been reached, Oncolytics hopes to submit the results and begin the Phase 2 trial, that could include about 14 patients.

"The company is getting a better understanding on how to deliver the product and optimize the delivery," said Coffey. "(In Phase 2) You really shift your efforts to recording the effectiveness of the treatments."

Last year, Oncolytics announced 11 of 18 people with a variety of different cancers had their tumours subside partially or fully after a single injection of Reolysin.

And research published in the June 20, 2001, issue of the Journal of the National Cancer Institute showed 20 of 23 mice that received a single reovirus injection had their tumours disappear completely.

Reolysin is based on the reovirus, which lives harmlessly in people`s intestines and lungs.

Scientists at the University of Calgary announced in 1998 they had discovered the virus kills certain cancer cells.

[e-mail]

Trial Results

This is a list of the status of brain-cancer patients who took a small dose of Reolysin in the Phase 1 trial for recurrent malignant glioma, as of May 6.

Patient number Date of Injection Survival time Status

from injection on May 6, 2003

TB-C101 June 27/02 9 months 23 days Died April 19, 2003

TB-C102 July 11/02 9 months 25 days Alive

TB-C103 July 25/02 2 months 7 days Died Oct. 2, 2002

TB-C201 Sept. 5/02 8 months 0 days Alive

TB-C202 Sept. 24/02 7 months 12 days Alive

TB-C203 Oct. 11/02 3 months 8 days Died Jan. 19/03

This story features a factbox "Trial Results".

[muycaro]

Oncolytics hat sich heute mal wieder ein neues Patent gesichert:

Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Inc. Announces Issuance of Seventh U.S. Patent
Wednesday May 21, 8:31 am ET


CALGARY, May 21 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) (`Oncolytics`) announced that it has been granted U.S. Patent 6,565,831 entitled "Method of Preventing Reovirus Recognition for the Treatment of Cellular Proliferative Disorders." Allowed claims in this patent cover co-administration of the virus with immune suppressing agents such as Cyclosporin. Additional allowed claims cover the use of the virus in combination with conventional therapeutic agents and treatments such as surgery, chemotherapy, and radiation therapy.

"The Company continues to expand its patent portfolio by anticipating possible REOLYSIN® usage in combination with existing therapies," said Dr. Matt Coffey, Vice President, Product Development.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill human cancer cells in vitro that are derived from many types of cancer, including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

This news release contains forward looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements, including the Company`s belief as to the safety and efficacy of REOLYSIN® co-administration with immune suppressing agents, alone and in combination with other therapies, including application by systemic delivery, and implications from the results of the Phase I clinical trial; the Company`s expectations as to the design, timing and success of its planned clinical trial programs, including the anticipated enrollment and commencement of additional clinical trials; and other statements related to anticipated developments in the Company`s business and technologies, all of which involve known and unknown risks and uncertainties that could cause the Company`s actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward looking statements. The Company does not undertake to update these forward looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/prnews/030521/to125_1.html

Chart+Quote:

http://finance.yahoo.com/q?s=ONCY&d=c&k=c1&a=v&p=s&t=3m&l=on…

[muycaro]

Press Release Source: Oncolytics Biotech Inc.

Oncolytics Biotech announces 2003 first quarter results
Thursday May 22, 8:31 am ET

CALGARY, May 22 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics" ) (TSX: ONC, NASDAQ: ONCY) today announced its financial results for the three-month period ending March 31, 2003.

First Quarter Highlights:

- Announced positive interim results from the T2 prostate cancer trial;
- Successfully completed a program for the development of a commercial
process to manufacture REOLYSIN(R);
- Successfully completed a ninth animal toxicology study using systemic
delivery of REOLYSIN(R); and,
- Secured a sixth U.S. patent covering a method of manufacturing
REOLYSIN(R).


"During the quarter, we made further advancements in the development of REOLYSIN®," said Dr. Brad Thompson, President and CEO of Oncolytics. "The Company achieved several important milestones."

Financial Review

The Company incurred a net loss for the first quarter of 2003 of $1,114,314 compared to a net loss of $1,273,820 for the first quarter of 2002. Basic and diluted loss per common share decreased from $0.07 in the first quarter of 2002 to $0.05 for the first quarter of 2003.

During the first quarter of 2003, the Company incurred R&D expenses of $479,635 compared to $871,519 in the first quarter of 2002. R&D expenses decreased in the first quarter primarily due to a reduction in the costs associated with the development of a commercial process for the manufacturing of REOLYSIN®. The Company continued to incur R&D expenses as it studied the efficacy and safety of REOLYSIN® in its clinical trial program and completed its animal toxicology study examining systemic delivery of REOLYSIN®.

During the first quarter of 2003, the Company incurred operating expenses of $522,025 compared to $489,478 in the first quarter of 2002. Operating expenses for the first quarter of 2003 increased due to strategic additions to Oncolytics` staff after the first quarter of 2002 and increased professional fees and filing costs associated with public company filing requirements.

The future income tax recovery of $161,905 recorded in the first quarter of 2002 related to the reversal of the Company`s future tax liability, as its future tax assets relating to non-capital losses, scientific research and development pools and other tax pools exceeded the value of the future tax liability. No similar recovery was recorded in the first quarter of 2003.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill human cancer cells in vitro that are derived from many types of cancer, including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including expectations as to progress in the clinical trial program and the Company`s belief as to the potential of REOLYSIN® as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, the Company`s ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements.

ONCOLYTICS BIOTECH INC.
BALANCE SHEETS

Unaudited Audited
March 31, December 31,
2003 2002
ASSETS $ $
------------ ------------
Current assets:
Cash 6,887,378 8,319,244
Accounts receivable 45,686 48,536
Prepaid expenses 77,433 77,158
------------ ------------
7,010,497 8,444,938

Capital assets 4,684,648 4,516,813

Investments 5,006,503 5,006,503

------------ ------------
16,701,648 17,968,254
------------ ------------
------------ ------------

LIABILITIES

Accounts payable and accrued liabilities 863,305 1,260,239
------------ ------------

Alberta Heritage Foundation loan 150,000 150,000
------------ ------------

Shareholders` equity:

Share capital 30,550,029 30,305,858
Contributed surplus 2,703,189 2,702,718

Deficit (17,564,875) (16,450,561)
------------ ------------
15,688,343 16,558,015
------------ ------------
16,701,648 17,968,254
------------ ------------
------------ ------------



ONCOLYTICS BIOTECH INC.
Statements of Loss and Deficit
(Unaudited)

Cumulative
For the three months ended from inception
March 31 on
2003 2002 April 2, 1998
$ $ $
---------------------------------------------
Revenue
Rights revenue - - 310,000
Interest income 43,170 57,180 1,815,848
---------------------------------------------
43,170 57,180 2,125,848
---------------------------------------------

Expenses
Research and development 479,635 871,519 14,056,516

Operating 522,025 489,478 5,329,098

Amortization 155,224 131,612 1,401,790
---------------------------------------------

1,156,884 1,492,609 20,787,404
---------------------------------------------

Loss before income taxes 1,113,714 1,435,429 18,661,556
Capital tax 600 296 18,319

Future income tax
recovery - (161,905) (1,115,000)
---------------------------------------------
Net loss for the period 1,114,314 1,273,820 17,564,875

Deficit, beginning of
the period 16,450,561 10,359,075 -
---------------------------------------------
Deficit, end of the period 17,564,875 11,632,895 17,564,875

Basic and diluted loss
per common share 0.05 0.07
---------------------------

Weighted average number
of shares 22,221,506 19,191,395
---------------------------
---------------------------



ONCOLYTICS BIOTECH INC.
Statement of Cash Flows
(Unaudited)

Cumulative
For the three months ended from inception
March 31 on
2003 2002 April 2, 1998
$ $ $
---------------------------------------------
OPERATING ACTIVITIES

Net Loss for the period (1,114,314) (1,273,820) (17,564,875)
Deduct non-cash items

Amortization 155,224 131,612 1,401,790

Future income tax
recovery - (161,905) (1,115,000)

Non-cash compensation
expense 471 - 33,189

Net change in non-cash
working capital (257,136) (1,341,393) 808,234
---------------------------------------------

(1,215,755) (2,645,506) (16,436,662)
---------------------------------------------

INVESTING ACTIVITIES

Intellectual property
expenditures (459,660) (149,130) (2,078,617)

Purchase of capital assets (622) (158,325) (460,865)

Investment in Transition
Therapeutics Inc. - - (20,352)

Investment in BCY
LifeSciences Inc. - - (127,123)
---------------------------------------------

(460,282) (307,455) (2,686,957)
---------------------------------------------

FINANCING ACTIVITIES

Alberta Heritage Loan - - 150,000

Proceeds from exercise of
warrants and options - - 2,760,103

Proceeds from private
placement 244,171 - 6,917,691

Proceeds from public
offering - - 16,183,203
---------------------------------------------

244,171 - 26,010,997
---------------------------------------------
Increase (decrease) in
cash during period (1,431,866) (2,952,961) 6,887,378

Cash, beginning of
the period 8,319,244 14,970,756 -
---------------------------------------------

Cash, end of the period 6,887,378 12,017,795 6,887,378
---------------------------------------------
---------------------------------------------

http://biz.yahoo.com/prnews/030522/to145_1.html

[muycaro]

Oncolytics announces proposed $6 million private placement

18:59 EDT Monday, June 09, 2003


/NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN

THE UNITED STATES. ANY FAILURE TO COMPLY WITH THIS RESTRICTION MAY

CONSTITUTE A VIOLATION OF U.S. SECURITIES LAW./

CALGARY, June 9 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that it has entered into agreements, subject to regulatory approval, to issue up to two million units at a price of $3.00 per unit, each unit consisting of one common share and one-half of one common share purchase warrant. Each whole common share purchase warrant will entitle the holder to acquire one common share in the capital of Oncolytics upon payment of $4.00 per share until the date that is 18 months following closing. The common shares to be issued by Oncolytics will be subject to a four-month hold provision. The private placement is anticipated to close on Thursday, June 19, 2003.

Proceeds of the sale of the units will be used by Oncolytics for general corporate purposes.


About Oncolytics Biotech Inc.


Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN(R), its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill human cancer cells in vitro that are derived from many types of cancer, including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that there were no toxicology-related issues with the administration of the reovirus, and that the reovirus demonstrated activity in tumours injected with REOLYSIN(R).

The securities to be issued by Oncolytics have not and will not be registered under the United States Securities Act of 1933, as amended (the "1933 Act"), or the securities laws of any state of the United States, and may not be offered or sold in the United States absent registration or an applicable exemption therefrom under the 1933 Act and the securities laws of all applicable states. This press release is not an offer of securities in the United States.


This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company`s expectations related to the private placement of the units as to progress in the clinical trial program and the Company`s belief as to the potential of REOLYSIN(R) as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, ability of the Company to complete the private placement on the terms set forth in its agreements, the Company`s ability to obtain regulatory approval for the offering, the availability of funds and resources to pursue Research and Development projects, the efficacy of REOLYSIN(R) as a cancer treatment, the success and timely completion of clinical studies and trials, the Company`s ability to successfully commercialize REOLYSIN(R), uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward- looking statements. The Company does not undertake to update these forward- looking statements.


For further information: For Canada: Oncolytics Biotech Inc., Doug Ball, 210, 1167 Kensington Cr NW, Calgary, Alberta T2N 1X7, Tel: [phone], Fax: [phone], www.oncolyticsbiotech.com; The Equicom Group, Joanna Longo, 20 Toronto Street, Toronto, Ontario M5C 2B8, Tel: [phone] ext. 233, Fax: [phone], [e-mail]; For United States: The Investor Relations Group, Gino De Jesus or Dian Griesel, Ph.D., 11 Stone St, 3th Floor, New York, NY 10004, Tel: [phone], Fax: [phone], [e-mail]

http://www.globeinvestor.com/servlet/WireFeedRedirect?cf=Glo…

[zet100]

scheint aber nicht so der Knall zu sein!!!

Andere Werte bekommen bei solchen Meldungen förmlich Flügel!!!

Oder, was sehe ich hier falsch?

[js200]

Oncolytics Biotech granted further US patent

Tuesday , June 10, 2003 12:40 ET

Jun 10, 2003 (Datamonitor via COMTEX) -- Canada`s Oncolytics Biotech has been granted US patent protection covering the use of combinations of reovirus strains for the treatment of Ras-mediated tumors.

"We are pleased with the expansion of our intellectual property portfolio," said Dr Matt Coffey, vice president of product development at the company in a media release. "This is our third US patent of 2003, and the first patent to include composition of matter claims."

Oncolytics is currently developing Reolysin, its proprietary formulation of the human reovirus, as a potential cancer therapeutic.


URL: http://www.datamonitor.com
Republication or redistribution, including by framing or similar means,
is expressly prohibited without prior written consent. Datamonitor shall not be liable for errors or delays in the content, or for any actions taken in reliance thereon


Copyright (C) 2003 Datamonitor. All rights reserved


-0-


KEYWORD: United States
SUBJECT CODE: All cancer
Healthcare biotechnology
Cancer, General


JS200

[js200]

RAiDAR alerts Learn More About RAiDAR-LT


06/10/2003 (12:40 ET) Oncolytics Biotech granted further US patent - Datamonitor



06/10/2003 (11:55 ET) New 6-K just released for ONCY - Edgar



06/10/2003 (10:06 ET) VOLUME(+): ONCY Volume 19% > 20-adsv, Stock +6.67% - Knobias



06/10/2003 (08:45 ET) Oncolytics Biotech Inc. Announces Issuance of Eighth U.S. Patent - Canada NewsWire



06/10/2003 (08:44 ET) Oncolytics Biotech Inc. Announces Issuance of Eighth U.S. Patent - PR Newswire



06/09/2003 (11:51 ET) VOLUME(+): ONCY Volume 26% > 20-adsv, Stock +17.92% - Knobias



06/09/2003 (08:08 ET) New 6-K just released for ONCY - Edgar



06/06/2003 (13:16 ET) VOLUME(-): ONCY Volume 41% > 20-adsv, Stock -14.17% - Knobias



06/06/2003 (12:34 ET) Oncolytics Biotech Inc. Sells Its Shareholdings In Transition Therapeutics - PR Newswire



06/06/2003 (12:34 ET) Oncolytics Biotech Inc. Sells Its Shareholdings In Transition Therapeutics - Canada NewsWire



05/30/2003 (16:14 ET) New 6-K just released for ONCY - Edgar



05/28/2003 (13:34 ET) ONCY: Short Interest UP 16.5% to 11.7K in May 2003 - Knobias



05/28/2003 (10:52 ET) VOLUME(-): ONCY Volume 14% > 20-adsv, Stock -8.64% - Knobias



05/28/2003 (06:32 ET) 6-K: ONCY Vote; Dir; Auditor; Stock Op Plan; Prvt Place - Knobias



05/27/2003 (10:41 ET) VOLUME(+): ONCY Volume 25% > 20-adsv, Stock +36.08% - Knobias



05/27/2003 (09:47 ET) 52W HIGH: New 52-Wk High for ONCY @ $3.110 up21.96% - Knobias



05/27/2003 (09:40 ET) GAP(+): Opening Higher OXGN, USOO, FNIS, SGGNF, ONCY - Knobias



05/23/2003 (12:53 ET) New 6-K just released for ONCY - Edgar



05/23/2003 (11:21 ET) 52W HIGH: New 52-Wk High for ONCY @ $2.260 up7.62% - Knobias



05/22/2003 (13:19 ET) Oncolytics Biotech narrows Q1 net loss to $1.1M from nearly $1.3 M last year - The Canadian Press (AP)



05/22/2003 (13:19 ET) Oncolytics Biotech narrows Q1 net loss to $1.1M from nearly $1.3 M last year - The Canadian Press (AP)



05/22/2003 (12:17 ET) Oncolytics Biotech narrows Q1 net loss to $1.1M from nearly $1.3 M last year - The Canadian Press (AP)



05/22/2003 (12:17 ET) Oncolytics Biotech narrows Q1 net loss to $1.1M from nearly $1.3 M last year - The Canadian Press (AP)



05/22/2003 (12:13 ET) Oncolytics Biotech narrows Q1 net loss to $1;1M from nearly $1;3 M last year - The Canadian Press (AP)



05/22/2003 (12:12 ET) Oncolytics Biotech narrows Q1 net loss to $1;1M from nearly $1;3 M last year - The Canadian Press (AP)

JS200

[muycaro]

Oncolytics ist einer der 25 Top Stock Picks der Business Week!!!

http://prosearch.businessweek.com/businessweek/SECTOR_WORST_…

[Bombenleger]

Oncolytics Biotech Inc. Granted Ras Targeted Adenovirus Patent
Tuesday July 22, 8:33 am ET

CALGARY, July 22 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) ("Oncolytics") announced that it has been granted U.S. Patent 6,596,268 entitled "Viruses for the Treatment of Cellular Proliferative Disorders." The claims in this patent cover the treatment of Ras mediated tumours using modified adenoviruses.

ADVERTISEMENT
"The addition of other viruses to our patent portfolio expands our potential product pipeline while strengthening and protecting our underlying core technology and lead product," said Dr. Matt Coffey, Vice President, Product Development of Oncolytics. "This is the Company`s fourth U.S. patent to issue in 2003, and the first patent related to other viruses that may target the Ras pathway as potential treatments for cancers."

Allowed claims in this patent cover the use of an adenovirus, modified by deleting the gene encoding for VA1, for the treatment of Ras mediated cancers, including, amongst others, lung, prostate, breast and colorectal. Deletion of the VA1 gene is believed to cause this virus to kill Ras activated cancer cells. Allowed claims also include using this modified virus in combination with conventional cancer treatment interventions such as surgery, radiation, chemotherapy, and immune suppressive agents including cyclosporin and rapamycin.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill human cancer cells in vitro that are derived from many types of cancer, including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

This news release contains forward looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements, including the Company`s belief as to the value of the adenovirus patent, the safety and efficacy of the use of modified adenoviruses; the Company`s expectations related to the applications of the patented technology, the ability of the technology to strengthen the core technology and the design, timing and success of planned clinical trial programs and other statements related to anticipated developments in the Company`s business and technologies, all of which involve known and unknown risks and uncertainties that could cause the Company`s actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward looking statements. The Company does not undertake to update these forward looking statements.


Source: Oncolytics Biotech Inc.

[js200]

07/22/2003 (12:11 ET) New 6-K just released for ONCY - Edgar
07/22/2003 (08:31 ET) Oncolytics Biotech Inc. Granted Ras Targeted Adenovirus Patent - Canada NewsWire
07/22/2003 (08:31 ET) Oncolytics Biotech Inc. Granted Ras Targeted Adenovirus Patent - PR Newswire
07/21/2003 (14:17 ET) VOLUME(-): ONCY Volume 46% > 20-adsv, Stock -0.47% - Knobias
06/27/2003 (13:19 ET) New 20-F just released for ONCY - Edgar


JS200

[r.schaui]

oncolytics steigt seit 3 tagen in usa und kanada unter grossen umsätzen um fast 50 %. hat jemand nähere informationen ? danke

[js200]

09/15/2003 (12:53 ET) 6-K: ONCY Files Sep-15 PR Regarding Scientific Advisory Board - Knobias
09/15/2003 (12:47 ET) New 6-K just released for ONCY - Edgar
09/15/2003 (10:02 ET) VOLUME(+): ONCY Volume 16% > 20-adsv, Stock +7.21% - Knobias
09/15/2003 (09:32 ET) CONF: ONCY To Present At Wall Street Analyst Conference - Knobias
09/15/2003 (08:30 ET) Oncolytics Biotech forms Scientific Advisory Board - PR Newswire

JS200

[js200]

RAiDAR alerts Learn More About RAiDAR-LT


09/15/2003 (12:53 ET) 6-K: ONCY Files Sep-15 PR Regarding Scientific Advisory Board - Knobias



09/15/2003 (12:47 ET) New 6-K just released for ONCY - Edgar



09/15/2003 (10:02 ET) VOLUME(+): ONCY Volume 16% > 20-adsv, Stock +7.21% - Knobias



09/15/2003 (09:32 ET) CONF: ONCY To Present At Wall Street Analyst Conference - Knobias



09/15/2003 (08:30 ET) Oncolytics Biotech forms Scientific Advisory Board - PR Newswire



09/12/2003 (11:01 ET) VOLUME(+): ONCY Volume 18% > 20-adsv, Stock +5.80% - Knobias



09/11/2003 (15:28 ET) 6-K: ONCY Files Sep-10 PR Regarding Presentation at Analysts Conf - Knobias



09/11/2003 (15:26 ET) New 6-K just released for ONCY - Edgar



09/11/2003 (11:21 ET) VOLUME(+): ONCY Volume 10% > 20-adsv, Stock +4.56% - Knobias



09/10/2003 (15:26 ET) VOLUME(+): ONCY Volume 113% > 20-adsv, Stock +2.35% - Knobias



09/10/2003 (13:07 ET) Media Advisory - Oncolytics Biotech to Present at The Wall Street Analyst Forum 49th NYC Analyst Conference - Canada NewsWire



09/10/2003 (13:06 ET) Media Advisory - Oncolytics Biotech to Present at The Wall Street Analyst Forum 49th NYC Analyst Conference - PR Newswire



09/08/2003 (10:51 ET) VOLUME(-): ONCY Volume 24% > 20-adsv, Stock -7.49% - Knobias



09/08/2003 (10:03 ET) DRG: Pharma Stks Higher on News, Upgrades - Knobias



08/29/2003 (09:12 ET) HCR: Jyske Banks Starts Healthcare Sector at Neutral - Knobias



08/26/2003 (16:19 ET) ONCY: Short Interest UP 4.9% to 11.0K in Aug 2003 - Knobias



08/26/2003 (10:27 ET) VOLUME(+): ONCY Volume 7% > 20-adsv, Stock +3.92% - Knobias



08/22/2003 (15:58 ET) DRG: R James Says Drug Approval Cycle to Boost Pharmas - Knobias



08/22/2003 (13:33 ET) 6-K: ONCY Files Aug-15 PR Regarding $4.1M Private Placement - Knobias



08/22/2003 (13:29 ET) New 6-K just released for ONCY - Edgar



08/18/2003 (14:45 ET) 6-K: ONCY Files Aug-15 PR Regarding $4.1M Pvt Placement - Knobias



08/18/2003 (14:07 ET) New 6-K just released for ONCY - Edgar


JS200

[Bertlk]

Ich sage nur eins die Umsätze und der Zuwachs sollten zu denken geben
Bertl

[merx]

Als kleine Nachtlektüre

http://virtualtrials.com/REOLYSIN.cfm



gut`s Nächtle


merx

[muycaro]

ONC share price calculator:

http://www.canadiantreeplanting.com/onc_share_price.html

Aber pssst...

[merx]

und sie steigt und steigt und steigt ...............


Wer weis wohin ????????


Gruß an alle Investoren so rund um 1 Euro.



Gruß

merx

[js200]

09/19/2003 (14:59 ET) DRG: Merrill Sees Attractive Valuations for Pharma Co`s - Knobias
09/19/2003 (12:21 ET) VOLUME(+): ONCY Volume 27% > 20-adsv, Stock +6.84% - Knobias
09/19/2003 (10:31 ET) 52W HIGH: New 52-Wk High for ONCY @ $3.640 up3.70% - Knobias
09/16/2003 (10:51 ET) VOLUME(+): ONCY Volume 11% > 20-adsv, Stock +2.09% - Knobias
09/15/2003 (12:53 ET) 6-K: ONCY Files Sep-15 PR Regarding Scientific Advisory Board - Knobias


JS200

[js200]

Last Trade: 3.970 Change: 0.460 (+13.105%)
Previous Close: 3.510 Volume: 334,100
Bid: 3.900 Ask: 3.930
Today`s Open: 3.500 # of Trades: 511


JS200

[js200]

.
http://www.investtech.com/nasdaq/ana/oncy.htm

JS200

[merx]

Was wird uns Dr.Coffey in NY erzählen ???

/10/2003 10:45:07 AM News Release Index


Oncolytics Biotech to Present at The Wall Street Analyst Forum 49th NYC Analyst Conference

Media Advisory

CALGARY, Alberta, September 10, 2003 –Dr. Matt Coffey, Vice President of Product Development, of Oncolytics Biotech Inc. (TSX: ONC, NASDAQ:ONCY), will present a corporate overview of the Company at The Wall Street Analyst Forum 49th NYC Analyst Conference. The conference will be held at the Roosevelt Hotel in New York City. Dr. Coffey will be presenting on Monday, September 15, 2003 at 12:30 p.m. ET.

The presentation will be webcast live from the conference, and can be accessed through the following websites: http://www.firstcallevents.com/service/ajwz387973416gf12.htm… or www.oncolyticsbiotech.com.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics’ researchers have demonstrated that the reovirus is able to selectively kill human cancer cells in vitro that are derived from many types of cancer, including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that there were no toxicology-related issues with the administration of the reovirus, and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

The webcast time is subject to change. This release and the presentation related thereto contain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company’s control and which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or expectations implied by these forward-looking statements.

FOR FURTHER INFORMATION PLEASE CONTACT:


For Canada:
Oncolytics Biotech Inc.
Cathy Ward
210, 1167 Kensington Cr NW
Calgary, Alberta T2N 1X7
Tel: [phone]
Fax: [phone]
[e-mail]

For Canada:
The Equicom Group Inc.
Joanna Longo
20 Toronto Street
Toronto, Ontario M5C 2B8
Tel: [phone] ext. 233
Fax: [phone]
[e-mail]

For United States:
The Investor Relations Group
Gino De Jesus or Dian Griesel, Ph.D.
11 Stone Street, 3rd Floor
New York, NY 10004
Tel: [phone]
Fax: [phone]
[e-mail]

Gruß

m e r x

[r.schaui]

Heute 15 % an der Nasdaq, gibt es news?
danke r.schaui

[MONSIEURCB]

Schau mal ins yahoo-board..es ist wohl ein Mix aus verschiedenen Empfehlungen, News, Insider-Reports etc...aber der Hauptgrund muss woanders und - hoffentlich - tiefer liegen. Anyway...macht Spass, abzuheben!

[merx]

Hier ein kleiner Überblick:


http://www.netera.ca/reovirus/



merx

[muycaro]

http://www.wallstreetwebcasting.com/webcast/rrshq/oncy/

[muycaro]

Ist das ein Hammer, oder wie jetzt?!?


_________________________________________________


Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech and The U.S. National Cancer Institute to collaborate on multiple clinical trials with REOLYSIN(R)
Wednesday October 29, 8:33 am ET


CALGARY, Oct. 29 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that support for multiple clinical trials to evaluate the efficacy of REOLYSIN® in a range of cancers has been approved by the Drug Development Group of the Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute ("NCI").

The NCI approved REOLYSIN® for collaborative development after an analysis of preclinical, GLP toxicology and clinical data. Oncolytics and the NCI will collaborate to select cancer indications and suitable development programs for a number of clinical trials. Oncolytics will provide REOLYSIN® for all clinical trials conducted and sponsored by the NCI under a Clinical Trials Agreement.

"We are pleased to collaborate with the National Cancer Institute to more broadly explore the potential of REOLYSIN®," said Dr. Bradley Thompson, President and CEO of Oncolytics. "This agreement will allow us to further evaluate the clinical utilization of REOLYSIN® using different routes of administration and in combination with current standard therapies."

About the National Cancer Institute

The National Cancer Institute is an agency of the National Institutes of Health (NIH), one of eight agencies that compose the Public Health Service (PHS) in the U.S. Department of Health and Human Services (DHHS). The NCI, established under the National Cancer Act of 1937, is the U.S. Federal Government`s principal agency for cancer research and training.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill human cancer cells in vitro that are derived from many types of cancer, including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that there were no toxicology-related issues with the administration of the reovirus, and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company`s expectations related to the success and benefits of the collaboration with NCI and the Company`s belief as to the potential of REOLYSIN® as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue Research and Development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, the Company`s ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/prnews/031029/to193_1.html

[merx]

Hallo muycaro und alle andern in ONC Investierten........

nun glaub ich kommt Schwung in unseren Wert.



Viel Glück und Durchhaltevermögen wünscht


m e r x

[muycaro]

To the moon baby, yeah!

[muycaro]

Aus der Online Ausgabe der kanadischen Tageszeitung The Globe and Mail von heute:



Oncolytics shares jump on drug trial news
U.S. cancer institute to finance multiple tests of Reolysin

By LEONARD ZEHR
00:00 EST Thursday, October 30, 2003

Shares of drug developer Oncolytics Biotech Inc. rose 7 per cent yesterday after the National Cancer Institute in the United States agreed to collaborate in an evaluation of the company`s experimental cancer drug Reolysin.

The stock gained 38 cents to $5.87 on the Toronto Stock Exchange in heavier-than-normal volume of 435,400 shares. It touched a 52-week high of $6.34 last week.

The NCI approved the collaboration after reviewing the drug`s preclinical, toxicology and clinical data.

Under the accord, it will finance "multiple clinical trials" of Reolysin, which is based on a naturally occurring human virus, or reovirus, that is not responsible for causing any disease.

While Oncolytics will supply the drug, the number of studies and types of cancer to be investigated have not been determined yet.

"This agreement will allow us to further evaluate the clinical utilization of Reolysin using different routes of administration and in combination with current standard therapies," said Oncolytics president and chief executive officer Brad Thompson.

One industry analyst said collaborations with the NCI are always positive.

"It`s a high-profile organization that lends a lot of credibility to a company`s drug candidate. The NCI does a lot of these collaborations and it`s always nice to be a part of that list."

But another source said this is a short-term positive for Oncolytics. "Reolysin is at an early stage in its development, so nothing is going to come out of these trials for a while. The best thing is that it will save Oncolytics money."

Calgary-based Oncolytics has been testing the drug with patients suffering from prostate and brain cancer.

It also is seeking approval to have Reolysin administered intravenously in patients with a variety of metastatic cancers.

The reovirus has been shown to infect, multiply and destroy human cells that have a so-called activated Ras pathway, a metabolic signalling mechanism that regulates cell division and growth.

In normal cells, the Ras pathway is turned on and off when needed. But in cancerous cells, the pathway is always on and cells divide out of control. More than half of all cancers exhibit this activated Ras pathway, the company contends.

© The Globe and Mail



http://www.theglobeandmail.com/servlet/ArticleNews/TPStory/L…

[r.schaui]

gibt es eine quelle/Informationen/Schätzungen wieviel potential in dieser aktie steckt? Umsatzerwartungen etc ?
r.schaui

[umbertoni]

CYGX Announces Collaboration Agreement

Thursday , October 30, 2003 10:21 ET

CytoGenix Inc. (CYGX) announced that it has entered into an agreement with the Albert Einstein College of Medicine, Department of Oncology for studies using the Company`s proprietary gene silencing DNA technology against a gene that is expressed in melanoma cells that produces a protein known to counteract the effect of several chemotherapeutic agents in difficult to treat cancers.

[umbertoni]

ooops sorry..vergesst das posting

[umbertoni]

war für nen anderen thread

[muycaro]

#41


Potentielle Wertberechnung für ONCY Aktien (als Markt werden dort nur die USA zugrundegelegt):
http://www.canadiantreeplanting.com/onc_share_price.html

Hier mal eine Einschätzung von 21st Century Investor (im April herausgegeben, danach einige Updates, aber nur positives bzgl. laufendem Progress, etc.):


Special Report
Last Updated on 04/29/2003
Finally -- The Cancer Drug to Get Extremely Excited About
By James M. DiGeorgia, Publisher
21st Century Alert
21st Century Investor Publishing, Inc.
1900 Glades Rd, Suite 441
Boca Raton, Florida 33431

Four months ago we first featured a special report on Oncolytics Biotech, Inc., the unknown Canadian company with the literally incredible cure for cancer. That`s right, we said cure for cancer. As you discovered in the report, Oncolytics`s reovirus compound, called Reolysin, invades and destroys cancer cells rapidly, in astonishingly large numbers, and without side effects. Many of the tumors treated with Reolysin simply disappear. The more deadly the cancer, the more Reolysin likes it. It`s simple and cheap to produce, too.
Now the company is finding additional applications for Reolysin, like decontaminating the stem-cell preparations which are commonly used after chemotherapy. Oncolytics is looking at a $30 billion dollar market.
It sounds like a pipe dream, but it isn`t. So far, all the animal and human clinical results from this unbelievable drug have far exceeded expectations. There`s only one problem: The stock market doesn`t seem to know Oncolytics exists. The stock was trading at $1.23 in December when we sent you the Special Report. It was trading this morning at $1.08.
Considering the stock market of the last few years, and the attendant low volumes, and the fact that biotech isn`t back in favor yet, Oncolytics`s stock chart looks pretty much like that of other similar biotechs. Still, we called the company to see whether there was something we should know. We came away with no doubts: When the market wakes up to this stock, look out.
The company has made several interesting announcements since then; we`re enclosing an updated copy of the report for you. The bottom line: Oncolytics was a buy in December at $1.23, and it`s a buy now.
Get Very Excited About This Cancer Drug!
It`s incredibly effective.
It`s safe at the highest doses.
It kills the deadliest cancers known.
It even destroys remote tumors far from the original cancer site.
And it`s inexpensive to make.
This drug is going to make billions of dollars when it hits the market.
It`s trading under $1.10 a share.
These days we`re thunderously skeptical whenever we see the words "cure" and "cancer" in the same sentence. After two generations of research and dozens -- if not hundreds -- of different approaches to knocking out this scourge, the mortality rates from cancer are pretty much what they were in 1970.
It`s always the same story with a "breakthrough" cancer drug. First everybody runs around screaming with delight and the stock skyrockets. Then without exception, the "cures" all seem to mysteriously fizzle out. Either they turn out to have vicious side effects, or they work on only one type of tumor, or they work perfectly on mice but not on humans, or most often, they work for a while . . . but the patient dies anyway. And the stock tanks.
Now, thanks to a Canadian biotech company you`ve never heard of, we may get the magic bullet we`ve been promised for decades: a cancer drug that reduces the majority of cancer tumors quickly, completely, and without side effects!
It`s almost ridiculously simple, too: This treatment is based on a harmless, common human virus. It kills cancer cells quickly, with incredible accuracy and in staggering numbers. It works on the most resistant and deadly cancers, it shrinks remote tumors far from the original site, it has no serious side effects at even the highest dosages, it`s inexpensive to produce -- and it`s in successful clinical testing on humans right now.
To the best of our knowledge of cancer treatments -- and we`ve researched quite a few -- no other compound we`ve heard of has this combination of effectiveness, thoroughness, rapidity and safety.
It`s trading at $1.03 a share.
Easily a billion-dollar drug
Welcome to a practically unknown little company with a laughably low stock price and bargain-basement market capitalization: Oncolytics Biotech, Inc. (Nasdaq: ONCY). Its compound, derived from live human reovirus, is called Reolysin and is based on discoveries made at the Department of Microbiology and Infectious Diseases at the University of Calgary in Alberta.
Just in the United States, it`s estimated that more than 1.3 million people will be diagnosed with cancer in 2003, and more than half a million will die. In the U.S., cancer accounts for one quarter of all deaths, second only to cardiovascular disease. Reolysin could conceivably be approved to treat more than 50% of cancer cases.
We`re talking about a 30-billion-dollar market.
If Reolysin continues to get the remarkable results it has so far -- and there`s no reason it shouldn`t, given the results it keeps getting -- it`s going to make an unfathomable fortune. Investors are going to watch the shares they bought for under $1.10 shoot into the triple digits.
Getting in on this stock now will be like buying IBM in 1953 . . . McDonald`s in 1966 . . . Berkshire Hathaway in 1967 . . . Microsoft in 1985. This is the kind of stock you kick yourself for the rest of your life for passing it up when it was cheap.
How does it work?
Cancer, we know, is characterized by the uncontrolled growth of cells. In most cases these cells accumulate and form tumors that can harm normal tissue and organ function. In many instances, cells from these tumors can break away from the original tumor and travel through the body to form new tumors elsewhere through a process called metastasis.
There are other live-virus-based drugs being tested for herpes, polio, measles, and similar diseases. These are so potent they have to be genetically altered so they won`t cause serious or even deadly diseases. But even weakened pathogen viruses can cause serious side effects or in extreme cases death.
That`s obviously bad for cancer patients but it`s bad for investors, too, because Federal Drug Administration approval of any cancer drug based on a live pathogen virus is going to be unbelievably tough.
The human reovirus is different. It can actually be used in its native state because it`s completely benign. We probably get infected by reovirus just as often as we do by the common cold; we just don`t notice. It`s abundant in nature, infecting through the respiratory and enteric (gut) system. However, it doesn`t cause the manifestation of any known disease, thus the name: Respiratory Enteric Orphan virus, or reovirus.
It`s also uncommonly stable: Researchers haven`t been able to get it to mutate, which is a huge advantage to the developer and the manufacturer. The compound remains effective and predictable throughout testing and processing without having to be altered first.
What does the reovirus do? Like any virus, it enters a cell. If the cell is normal and healthy, its PKR cellular protein will arrest the virus by binding to it before it can start to replicate. Game over.
However -- and this is the key -- the reovirus can be arrested only by cells with a normal Ras pathway. A normal Ras pathway transmits an orderly progression of growth and developmental signals within the cell; these signals regulate normal cell growth and survival. Like almost every other organic process, the Ras pathway is not always "switched on." An always-switched-on Ras pathway is referred to as "activated" -- and an activated Ras pathway cannot stimulate an anti-viral response to the PKR enzyme.
So when a reovirus enters a Ras activated cell, the reovirus, meeting no resistance, can replicate freely and kill the cell. The "always on" Ras mutation that causes the uncontrolled cell growth of cancer in the first place is what makes it vulnerable to the reovirus that will ultimately destroy it.
Which is what happens with Reolysin. Reolysin particles grow so quickly in a Ras-activated cell that the cell ruptures and dies, freeing progeny viruses to infect surrounding cancer cells until they too explode in staggering numbers. This cycle of infection-replication-cell death is thought to be repeated until there are no longer any tumor cells with an activated Ras pathway.
Simply put: Reolysin is a cancer-seeking missile that works swiftly and with deadly accuracy, and has no interest in destroying anything else.
It gets better. Activated Ras pathways may play a role in more than two thirds of all human cancers, which means Reolysin is a potential treatment for the majority of human cancer cases. That includes, but isn`t limited to, malignant glioblastomas (brain cancer) and pancreatic, colon and some lung cancers -- the most virulent and frightening cancers of all.
Safe even at the highest doses
In animal tests so far, Reolysin has effectively cured implanted human cancers including brain, breast, prostate, ovarian and colorectal cancers. It all sounds too good to be true. It has to have severe and harmful side effects, right?
To find out how amazing Reolysin really is and what kind of potential it has, look at the human clinical trial that was reported on last year, a study of 18 terminally-ill patients with actively growing cancers that had failed to respond to any conventional treatments. The study examined the effects of injecting increasing dosages of Reolysin directly into a subcutaneous (under-the-skin) tumor.
You`d think that something this powerful would have a savage level of toxicity, or even fatal side effects, considering that billions of reovirus particles were injected into patients` tumors. But astonishingly, it didn`t. Not one of the patients receiving Reolysin experienced any serious adverse events related to the virus, nor were there any dose-limiting toxicities detected in any patient, even at the highest dosage, which was up to 100 times the perceived therapeutic dose. There was no harmful effect on healthy cells or healthy tissue. Like everything else about Reolysin, this is exciting, considering that some very ill patients with compromised immune systems were treated with a massive live viral load.
Compare that to the harsh, debilitating effects of chemotherapy or radiation. Over the years, toxicity has kept a dismayingly large number of cancer treatments off the market. Not only can certain treatments cause lethal damage to tissues and organs, but they can cause such severe nausea, dizziness and lethargy, to name just a few side effects, that patients often refuse to continue treatment.
As it stands now, toxicity simply is not a problem with Reolysin.
The deadlier the cancer, the better it works
The secondary outcome of the study was a surprisingly high tumor response. Eleven out of 18 patients, or 61%, showed evidence of either temporary or lasting tumor regression after being injected with Reolysin, with the regression ranging from 32% to an unbelievable 100% of the tumor.
61% success is extremely rare in a Phase I study, where a 10% response rate is considered cause for celebration. Even more encouraging was that these patients had a variety of cancers such as head and neck, breast, melanoma, non-AIDS Kaposi`s sarcoma and others. And they weren`t even screened for Ras activation.
There`s more. Astonishingly, researchers found remote tumor response with Reolysin: Every patient with multiple tumor sites showed that the virus worked not only in the injected tumor but in the remote tumors as well, which means Reolysin may have a role in the treatment of the metastases that characterize advanced cancers.
Reolysin doesn`t work on every cancer cell line known, but researchers were fascinated to discover that thedeadliest, hardest-to-treat cancers are the most susceptible to it, possibly because they have a higher level of Ras-activation. And there`s another hard-to-believe bonus: Besides working via injection directly into the tumor, Reolysin also works through intravenous systemic delivery: Inject a few billion virus particles into the bloodstream and they will search out metastatic cancer sites and destroy them. And every cancerous cell infected with the virus will release more virus particles that will go on tolook for the next cell to invade and destroy.
Stock should gain $2 for every 1,000 patients treated
The charge per treatment for Reolysin is $10,000, with a conservative royalty rate of 20%. At this point trying to determine a precise potential market valuation for Oncolytics is impossible. But the company suggests that after approval, Oncolytics`s stock price will appreciate about $2 for every 1,000 patients treated with Reolysin.
This is the math: Assume 1.3 million new cases diagnosed just in the U.S. in 2003. Since not everyone diagnosed with cancer will seek or be evaluated for further treatment, let`s make that a conservative half-million new cases, just to be conservative. Two-thirds of those cases, or 330,000, will be Ras activated. Even if only half of those patients seek treatment with Reolysin, it puts the stock price at over $300 a share. And that`s just new cases.
Probably the first cancer Reolysin will be FDA-approved for is malignant glioblastoma, followed by prostate cancer and eventually pancreatic cancer. There are about 9,000 cases of malignant glioblastomas in the U.S. every year, about 180,000 cases of prostate cancer, and about 29,000 cases of pancreatic cancer. Add "off-label" use (for conditions other than the approved indication), future approval for additional indications, and systemic delivery to metastatic cancers and the ultimate market for Reolysin is, quite simply, incalculable.
A classic "story stock"
Since the beginning of this year there has been an endless wave of exciting news about Reolysin:
In February the company announced the successful completion of its program for developing a viable commercial process for manufacturing Reolysin easily, inexpensively, and in compliance with government guidelines. This "behind-the-scenes" process is critical to the success of any drug (and a stumbling block through the years for many other cancer compounds.) At the current scale of operations, one manufacturing run should supply sufficient material for all of Oncolytics`s anticipated clinical studies for the next two years. As an example of the productivity of the manufacturing process, a liter of primary cell culture could produce 100 to 1,000 doses of this purified final product. Naturally, the company has filed selective patent applications and in March was granted a patent on the manufacturing process. Last year the company was granted its first European patent for reovirus technology.
Also in February Oncolytics announced the results of its animal toxicology program to examine the systemic delivery of Reolysin. Every method of drug administration -- oral, subcutaneous, intravenous -- has to be examined for toxicology in animals before starting the human clinical trials that count toward approval of the drug. Oncolytics has now successfully completed nine toxicology studies examining three different routes of administration. Reolysin appears well-tolerated in all three animal species used. In one test, small primates received Reolysin daily via intravenous infusion for 28 days. At the maximum daily dose used in the study, each animal received from 10 to 100 times the daily expected maximum single human dose per unit of body weight without a single product-related adverse event.
In March Oncolytics made a particularly exciting announcement about a potential new use of Reolysin beyond what has already been explored: as a treatment to purge stem cell preparations of contaminating cancers. Blood-derived stem-cell rescue treatments are commonly used after chemotherapy for both solid tumors and blood tumors. These stem cell preparations are usually "autologous," or prepared from the patients` own blood. But an estimated 30% of these autologous stem cell transplants are contaminated by cancer cells. In Oncolytics`s study, Reolysin purged the contaminating cancer cells in these patient-derived preparations.
Two researchers published studies on the use of Reolysin to treat metastatic disease and kill pancreatic cancer cells.
In late March, Oncolytics reported the results of a T2 prostate cancer trial in six human patients three weeks before prostate surgery. After Reolysin was delivered directly into the tumor, there was tumor-cell death in four out of six patients; the fifth patient`s prostate gland shrank by an astounding 67%. And as usual, there were no side effects. Cancer of the prostate is one of the most common cancers in men, representing about one-third of all male cancers in western society. It`s second only to lung cancer as the leading cause of cancer deaths in men. There were an estimated 18,200 new cases of prostate cancer in Canada in 2002 and the American Cancer Society estimates nearly 221,900 new cases in the U.S. in 2003.
Despite the steady stream of good tidings, the stock market hasn`t been kind to Oncolytics. Its market capitalization right now is absurdly low, only $23 million. And the stock is trading at -- sit down -- $1.03. With its stock behavior similar to other small clinical-stage biotechs, Oncolytics is down from a high near $5.50 in late 2001, proving once again that even the most promising stock can be prey to every rumor and wildly volatile.
One obvious reason for the stock`s slump is the market downturn of the last few years, which resulted in low volumes, which in turn aggravated the problem. Moreover, biotechs aren`t entirely back in favor yet. But the company has had some bad luck of its own. First, for no apparent reason and in spite of its own excellent research results, drug-giant Pfizer terminated a smoothly-running veterinary partnership with Oncolytics, which panicked investors and sent the stock plunging -- it lost two-thirds of its market capitalization. And Synsorb, the company that spun off Oncolytics in 1998 and retained 40% ownership, ran out of cash and sold its stake, flooding the market with over 7 million shares.
Oncolytics is still a local Canadian story with a mainly local investor base. The company has not reached the required "critical mass" for institutional involvement and few U.S. investors have even heard of Oncolytics or Reolysin. When trials are further along, especially after a successful Phase II, the media should pick up on Oncolytics and introduce it to a much broader potential investor base.
The last of Synsorb`s shares were sold in November. With the selling pressure largely dispersed, and good news coming steadily out of the company, alert investors are looking at a very rare buying opportunity.
Imagine a cure for prostate and brain cancer
Oncolytics is in a Phase I/II clinical trial to study the efficacy and dose-limiting toxicity, if any, of Reolysin in patients with recurrent malignant glioblastomas -- a very deadly form of brain cancer -- that don`t respond to surgery, radiation or chemotherapy. Until now, this kind of tumor was purely a death sentence: The five-year survival rate is about 3%. None of the patients in Oncolytics`s study was expected to live longer than three months, but already four out of six patients have survived from seven through almost 10 months. In Oncolytics`s preclinical animal studies, 90% of glioblastomas in mice treated with Reolysin simply disappeared after a single injection.
Phase I of this trial is being done in Canada; Phase II will take place in the United States, as the FDA requires tests to be done on Americans. Reolysin stands a good chance of becoming the standard treatment for even something as deadly and fast-growing as glioblastoma. Since alternative treatments for malignant glioma are limited, the bar for new therapies is low, so this study could be the ticket to Reolysin`s fast approval.
There are other potential applications. For example, it`s not entirely understood how, but reovirus may sensitize cancer cells to chemotherapy; so cancer cells that have developed resistance to chemotherapy may respond to chemotherapy drugs again after reovirus treatment.
Beyond its use as a cancer therapy and now possibly as a decontaminant for stem-cell preparations, the reovirus may have still-unexplored uses against other proliferative diseases like some arthritic conditions and neurofibromatosis. Oncolytics already has patent protection on these potential applications; in fact, the company has carefully filed patents on every aspect of Reolysin, covering the manufacturing process, the administration of the drug, how the drug works, what it works on and dosage ranges, among others. The company already has six U.S. patents with almost 100 pending.
Big pharmas are sniffing around
The company has been fairly close-mouthed about suitors, but there`s evidence that several major pharmaceutical companies have approached Oncolytics with an eye to licensing and marketing Reolysin. Big pharmas rarely take casual chances on little research-stage drug companies. If they want to get their hands on Reolysin, you can bet they have a good reason. Wisely, Oncolytics is waiting for more results from the current clinical trials in order to get the best possible deal for itself and its shareholders.
Also very intelligently, Oncolytics asked two big pharmaceuticals to review its clinical protocols. "What do you like to see discussed in a clinical trial write-up?" Oncolytics asked. "Tell us now what we should be covering so that when we show you a report next year you don`t tell us we missed something important." It`s highly unusual for a large pharmaceutical to trouble itself with this kind of request, but two major companies have done it for Oncolytics, giving it seven critical categories of information to cover.
Oncolytics holds minority positions in two other Canadian biopharmaceutical companies: BCY LifeSciences, which has license rights to technologies to treat certain diseases of the respiratory tract including cystic fibrosis; and Transition Therapeutics, which is developing innovative therapeutics focusing on the treatment of multiple sclerosis, diabetes and restenosis.
The company`s management is unusual. They pay themselves relatively modest salaries and haven`t issued themselves endless free shares of stock. They`re focusing on building a solid patent base that will eventually produce revenue. Quietly and steadily, Oncolytics is laying the groundwork for the approval of a truly revolutionary and wildly profitable drug.
We haven`t seen a risk-reward ratio like this in a long time
Of course a young clinical-stage biotech like this has no revenue, and Oncolytics recently reported predictable financial results: Fourth-quarter losses were up slightly from the fourth quarter a year ago, although total loss for 2002 was down somewhat at about $6.1 million. The company ended the year with about $8.3 million in cash. Interestingly, the company`s "burn rate," or the amount of money it spends, is decreasing, since the greatest expense was in the pre-clinical animal- and toxicology-testing stage and in developing the manufacturing process.
There are other hurdles to be cleared before Reolysin hits the market: Trials so far have been small and there`s no official long-term survival study. Reolysin could fail in advanced clinical trials. Oncolytics is so far a one-drug company so if Reolysin fails, Oncolytics fails. Oncolytics could run low on cash and be unable to secure financing, although we believe it expects a partnership soon and a sizeable upfront payment. The company could fail to deliver on its timeline and lose investor confidence, although the speed with which they`ve advanced so far is impressive, and the company estimates conservatively that Reolysin could be on the market by late 2005.
We know clinical-stage biotechs aren`t for everyone. And we don`t recommend sinking too much capital into Oncolytics at this point because it`s not entirely out of the woods.
But the great thing about Oncolytics is that you don`t need to sink too much capital into the stock because its risk-reward ratio is so mind-boggling. A few thousand, or even just a few hundred, shares purchased now will give you tremendous returns. We guarantee that like any promising biotech the stock will fluctuate crazily until it starts heading straight up after successful Phase III trials.
Oncolytics is a buy now and at any price above $1. Its first "breakout" price will be around $1.80 or $2.00. Five years from now with the stock in the high double-digits, imagine telling people, "I bought Oncolyticis at a buck-three."

________________________________________________________

Viel Glück bei Deiner Entscheidung.
Disclosure: Ich besitze Aktien des besprochenen Unternehmens.

[muycaro]

Achso, mittlerweile (seit dem oben geposteten Report) haben Oncolytics übrigens über $20 Mio. Cash (+ etliche neue Patente). Ausserdem wird Ihnen die Partnerschaft mit dem U.S. National Cancer Institute, die Ihnen die Versuche bezahlen wird (Oncolytics braucht nur das Medikament (Reolysin/Reovirus) zur Verfügung zu stellen, Ihnen mindestens Kosten im hohen zweistelligen Millionenbereich ersparen.

[muycaro]

Der 21st Century Report hat übrigens $295 (US) gekostet.

[muycaro]

Noch eine Anmerkung: http://www.21stcenturyalert.com ist normalerweise recht bearish bei den meisten Werten die von Ihnen besprochen werden.

[r.schaui]

#45 danke ich besitze übrigens auch aktien dieser gesellschaft (aus der erbmasse von synsorb)
r.schaui

[muycaro]

Oncolytics auf der Titelseite Slashdot.org, einem sehr(!!!) gut besuchten (mehrere 100.000 Page Impressions am Tag) US Forum für "Geeks" (Intellektuelle, meist Computerfreaks und wissenschaftlich interessierte Leute), schon 260 Kommentare dazu in nur einer Stunde!!!

Killing Cancer With a Virus

Posted by Hemos on Tuesday November 04, @02:55PM
from the kill-it-dead dept.
just___giver writes "The U.S. National Cancer Institute has just decided to fund multiple human clinical studies to test the reovirus. This naturally occuring virus has a remarkable ability to infect and kill cancer cells, without affecting normal, healthy cells. Here is a before and after picture of a terminal patient with an actively growing neck tumour that had failed to respond to conventional treatments. This tumour was eliminated with only a single injection of the Reovirus. Researchers at Oncolytics Biotech have shown that the Reovirus can kill many types of cancer, including breast, prostate, pancreatic and brain tumours. Human clinical trial results indicate that there are no safety concerns and that the reovirus shrinks and even eliminates tumours injected with this virus. Numerous other third party studies show that the reovirus should be an important discovery in the treatment of 2/3 of all human cancers."

http://science.slashdot.org/science/03/11/04/1816227.shtml?t…

________________________________________________

Spread the Word...

[muycaro]

Jetzt über 300 Kommentare in nicht mal 90 Minuten - wenn erstmal die "weak hands" komplett raus sind, gibt es für ONCY nur noch eine Richtung! Fasten your seatbelts!

[boom2]

auch recht informativ:
http://www.stockta.com/cgi-bin/analysis.pl?symb=ONCY&num1=35…

[muycaro]

Auf ArsTechnica.com wird ONCY nun auch erwähnt:

http://arstechnica.com/archive/news/1067997007.html

[muycaro]

YALE UNIVERSITY News Release

CONTACT: Jacqueline Weaver, 203-432-8555 #286

For Immediate Release: Thursday, October 9, 2003

Yale Researchers Find Genetic Basis for Metastatic Cancer

New Haven, Conn. -- Yale researchers have found genetic mutations that are potential drug targets for metastatic cancer, according to a study published today in Science.

In addition to providing a target for a drug that would inhibit the spread of cancer, the finding also could lead to early screening tests for tumors most likely to metastasize.

The results are significant because the leading cause of cancer deaths is metastasis, which is when cells from the original tumor travel to other parts of the body, forming new tumors. Cancer is often fatal when it has progressed to this stage.

The principal investigator of the study is Tian Xu, professor and vice chair of the Department of Genetics at Yale School of Medicine and an associate investigator for the Howard Hughes Medical Institute. "The problem for researchers," he said, "is that it is hard to determine the genetic basis for metastasis because late stage cancers cause a cascade of cell mutations, making it difficult if not impossible to determine which mutations cause the metastases."

To address this problem, Xu and a graduate student, Raymond Pagliarini, generated tumors in fruit flies, or Drosophila melanogaster. Since the genes in fruit flies are remarkably similar to those in humans, results from genetic experiments on fruit flies have direct implications toward understanding human development.

Tumors resulting from a mutation in a gene called Ras, also commonly disrupted in human tumors, did not metastasize in the fly. The researchers then screened a large number of additional mutations to see which could make these tumors spread. Only a small number of mutations from the initial test group caused tumors to metastasize. Each of the new mutations affect cell polarity maintenance, a process that is critical in allowing cells to communicate with their surroundings. But these mutations alone cannot cause metastases to form.

Xu and Pagliarini then surveyed a number of different early tumor-initiating mutations and found that only Ras mutations could cooperate with the cell polarity gene mutations to make tumors spread.

"This concept, previously underappreciated, has major implications toward our understanding of why tumors of distinct origins have such different potentials for metastasis," Xu said. "By finding common sets of gene mutations that can make a tumor metastasize, this guides us to specific biological processes that can be targeted by drugs to inhibit metastases. It also implies that we may soon have a better ability to detect early on which tumors require the most intensive treatment to stop the progress of cancer."

_____________________________________________________

WOW! Denke wir sind genau auf dem richtigen Weg!!!

[muycaro]

"Activated Ras and Akt Tyrosine Kinases Cooperate to Induce Glioblastomas in Mice

WESTPORT, May 30 (Reuters Health) - Mutated forms of the Akt and Ras tyrosine kinases, but neither protein alone, can cause high-grade gliomas in a mouse model of the disease. These findings, from a report published in the May 2000 issue of Nature Genetics, suggest that therapeutic approaches for treatment of gliomas should attempt to disrupt both pathways. "



http://www.genomelink.org/glioblastoma/

[muycaro]

Auch interessant (zumindest für die, die sich damit mal beschäftigen wollen):


Cancer arises from the stepwise accumulation of genetic changes that confer upon an incipient neoplastic cell the properties of unlimited, self-sufficient growth and resistance to normal homeostatic regulatory mechanisms. Advances in human genetics and molecular and cellular biology have identified a collection of cell phenotypes — the main destinations in the subway map below — that are required for malignant transformation1. Specific molecular pathways (subway lines) are responsible for programming these behaviours. Although the connections between cancer-cell wiring and function remain incompletely explored and specified — hence the many lines under construction — the broad outlines of the molecular circuitry of the cancer cell can now be sketched. Further advances in understanding these pathways and their interconnections will accelerate the development of molecularly targeted therapies that promise to change the practice of oncology.


How to use this resource

Click on any of the stations on the map to go to the LocusLink entry for that gene or group of genes. Click on the main stations (Boxed text) to go to a description of the pathway (Anmerkung - funktioniert nur auf der originalen Webseite, siehe Link unten).



http://www.nature.com/nrc/journal/v2/n5/weinberg_poster/

[muycaro]

Auszug aus einem FDA Dokument über benötigte Endpunkte/Ziele klinischer Versuche auf dem Weg zur [beschleunigten] Zulassung eines Medikamentes (komplettes Dokument siehe verlinktes .pdf File):


"End Points and United States Food and Drug Administration Approval of Oncology Drugs
By John R. Johnson, Grant Williams, and Richard Pazdur

Purpose: To summarize the end points used by the United States Food and Drug Administration (FDA) to approve new cancer drug applications over the last 13 years.

Materials and Methods: The FDA granted marketing approval to 71 oncology drug applications between January 1, 1990, and November 1, 2002. The end points used as the approval basis for each application are presented, and the rationale for each end point is discussed.

Results: The FDA grants either regular marketing approval or accelerated marketing approval for oncology drug applications. Regular approval is based on end points that demonstrate that the drug provides a longer life, a better life, or a favorable effect on an established surrogate for a longer life or a better life. Accelerated approval (AA) is based on a surrogate end point that is less well established but that is reasonably likely to predict a longer or a better life. Tumor response was the approval basis in 26 of 57 regular approvals, supported by relief of tumor-specific symptoms in nine of these 26 regular approvals. Relief of
tumor-specific symptoms provided critical support for approval in 13 of 57 regular approvals. Approval was based on tumor response in 12 of 14 AAs.

Conclusion: End points other than survival were the approval basis for 68% (39 of 57) of oncology drug marketing applications granted regular approval and for all 14 applications granted accelerated approval from January 1, 1990, to November 1, 2002.

J Clin Oncol 21:1404-1411. © 2003 by American
Society of Clinical Oncology."


http://www.fda.gov/cder/drug/cancer_endpoints/endpointsArtic…



Zustz (.pdf File):

"In contrast, [accelerated approval] in oncology has usually relied on response rate as the surrogate end point in patients with highly refractory cancer without available therapies, usually determined in nonrandomized trials with limited patient numbers. Clinical benefit is to be subsequently demonstrated in randomized trials after drug approval, usually in patients with less refractory tumors."

_____________________________________________________



Meint Ihr ONCYs Glioblastoma Multiforme Trials könnten für eine beschleunigte Zulassung ausreichen (vor Ende der Testphasen), da ja offensichtlich keine adäquaten/wirkungsvollen Alternativen in diesem Behandlungsgebiet gegeben sind und somit ein unmet need besteht?
Ich denke solange in den nächsten Versuchen weiterhin das bis dato gewohnte Sicherheitsprofil, und Oncolytics weiterhin die tumorseitige Wirkungsweise von Reolysin demonstrieren kann, liegt dies denke ich nicht ganz ausserhalb des Möglichen.

[araucarius]

Hallo zusammen,
habe diese Aktie auch schon länger (seit Synsorb) und bin eifriger Leser der US-Boards.
Hier könnt Ihr Euch mal die Aktienoptionen der einzelnen Oncolytics Mitarbeiter anschauen.
Einfach in der liste der Firmen nach unten scrollen...
Stand ist der 15.08.2003

http://www.cvmq.com/upload/bulletin/v34n32chab.pdf

gibt noch 98 andere Documente bei

www.cvmq.com

Einfach oncolytics als Suchbegriff eingeben

Viel Spaß beim stöbern...

[muycaro]

News:
Neues Patent auf die Behandlung von Krebs mit dem Herpes Simplex Virus/Ras Pathway.
Damit hätten wir also rasmäßig den Reovirus, Adenovirus und Herpesvirus abgedeckt. Denke wenn das so weitergeht wird das für einige andere Unternehmen noch mal ein böses Erwachen geben, wenn sie merken, dass Oncolytics so ziemlich alle Patente in dem Bereich (Krebsbehandlung per Ras Pathway mittels Virii) besitzt.
Sieht gut aus.



Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Granted Ras Targeted Herpes Virus Patent
Tuesday November 18, 8:30 am ET


CALGARY, Nov. 18 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) ("Oncolytics") announced that it has been granted U.S. Patent 6,649,157 entitled "Viruses for the Treatment of Cellular Proliferative Disorders." The claims in this patent cover the treatment of Ras mediated tumours using modified herpes viruses.

"We now have issued patents covering the treatment of cancers using three groups of viruses, including herpes, adenovirus and reovirus, that target the Ras pathway," said Dr. Matt Coffey, Vice President, Product Development of Oncolytics. "Herpes viruses having alterations in the (gamma)34.5 gene are commonly used in programs ranging from basic research to advanced clinical studies."

The issued claims in this patent cover the use of a herpes virus that has been modified by a mutation in the (gamma)34.5 gene, for the treatment of Ras mediated cancers. This is believed to cause this virus to provide specificity in Ras activated cancer cells.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that in vitro the reovirus is able to selectively kill human cancer cells that are derived from many types of cancer, including breast, prostate, pancreatic and brain tumours. They have also demonstrated successful results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

This news release contains forward looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements, including among others, the Company`s belief as to, the safety and efficacy of the modified herpes viruses; the Company`s expectations as to the potential applications of the patented technology and other statements relating to anticipated developments in the Company`s business and technologies, involve known and unknown risks and uncertainties that could cause the Company`s actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward looking statements. The Company does not undertake to update these forward looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/prnews/031118/to096_1.html

[muycaro]

Hier nochmal der Link zur eigentlichen Patentschrift:

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=H…

[muycaro]

Denke wenn das so weitergeht wird das für einige andere Unternehmen noch mal ein böses Erwachen geben, wenn sie merken, dass Oncolytics so ziemlich alle Patente in dem Bereich (Krebsbehandlung per Ras Pathway mittels Virii) besitzt.


Gerade sag ich es noch und schon ist es passiert:

http://www.crusadelabs.co.uk/therapy.htm

[merx]

Mensch, da hat ja auch der Lehrerpensionsverein von Calgary
150.000,00 von den Dingern gekauft.

[muycaro]

Canadian Cancer Society:

Research milestones from the 2000s


Reducing risk of breast cancer recurrence
A clinical trial funded by the Canadian Cancer Society found in 2003 that post-menopausal survivors of early stage breast cancer who took the drug letrozole (also called Femara) after completing an initial 5 years of tamoxifen therapy had a 43% reduced risk of cancer recurrence compared to women taking a placebo. The research is significant because more than half of women who develop recurrent breast cancer do so more than 5 years after their original diagnosis. Prior to this research, there was no treatment to reduce the risk of recurrence after 5 years of tamoxifen. Just over half of women with breast cancer are potentially eligible for this new treatment.

A good virus?
In 2001, a cancer biologist at the University of Calgary , now at Dalhousie University in Halifax, Nova Scotia, discovered that a common and relatively harmless virus called a reovirus could kill a certain kind of cancer cell. Dr Patrick Lee and co-researcher Dr Peter Forsyth injected live reovirus into experimental mice carrying malignant gliomas and also into cells taken from patients with gliomas, the most common type of brain tumour affecting people. The tumours either regressed completely or shrank significantly. Clinical trials in humans are now underway to see whether the reovirus could be an effective new treatment option for this invasive and aggressive type of cancer.

“Impact factor” highest for Canadian clinical cancer research
A study ranking the impact of clinical, or patient-oriented, cancer research around the globe concluded that Canadian clinical cancer research is the best in the world. The Italian study, which was published in the January 2003 issue of the European Journal of Cancer, rated the so-called “impact factor” – how often clinical cancer research articles published between 1995 and 1999 were cited over the next 2 years in major scientific journals.

“Canada ranks ahead of every nation, and that is very gratifying,” said Dr Michael Wosnick, executive director of the National Cancer Institute of Canada, which channels funding from the Canadian Cancer Society to Canadian researchers. “The study shows Canadians do world-class cancer research, and in particular, research that directly impacts cancer patients. We may not always have the kind of budgets our colleagues in other countries have, but we have developed a knack for getting a big bang for our research buck,” he added.

http://www.cancer.ca/ccs/internet/standard/0,2704,3543_13703…

[merx]

Hey was soll das ?????

Coffey und Thompson verkaufen Ihre Shares.

Coffey 7500 und Thompson 9500 ?????


Ist was im Busch ?????


Muycaro was sagst Du dazu ???

[muycaro]

Das waren zusammen nicht mal 20.000 Aktien die sie vorher am freien Markt gekauft hatten. Beide halten jedoch zusammen weit über eine Million Optionen, von daher waren das nur Peanuts. Vielleicht wollten die Weihnachten mal richtig auf den Putz hauen.
Ich werde heute nochmal nachlegen.
Nur Geduld...und ruhig Blut!

Ich sehe ONCY als DIE Chance im Biotechbereich überhaupt. Langfristig gesehen sind exorbitante Kurssteigerungen möglich, siehe bspw. den inoffiziellen Share Price Calculator. Das Risiko-/zum potentiellen Gewinnverhältnis halte ich aufgrund des starken Patent Portfolios, sowie dem Sicherheitsprofil von Reolysin für ausserordentlich gut.

[muycaro]

Grüss Dich merx.
Habe wie gestern angekündigt nochmal mit langfristig frei gewordenem Kapital einige tausend ONCY à $3,35-3,40 nachgelegt.
Heute um 22:00 Uhr MEZ gibt es übrigens ein Interview mit dem CEO von Oncolytics auf http://www.biotechtoday.net/


_____________________________________________________

Hier nochmal ein Posting von stockhouse.ca, das ziemlich genau meine Ansicht bezüglich der langfristigen Spekulation auf Oncolytics beschreibt:



SUBJECT: If you are LONG there is no worries ! Posted By: vronzulli
Post Time: 11/25/03 18:20
« Previous Message Next Message »

I have been reading your posts for over a month now without participating at all in the nonsense. I must say, when I started reading I thought it was a very different board than say Yahoo or Raging bull. Well, let the stock tank a bit, and here it comes, the bashing, the seasoned investors? and everyone else that feels that they know better than the company management (if they did, how come they are on this side of the board ! Think about it for a while).
The truth of the matter is that this is comical at best and absurd at worst. The people that have really done their DD and analysis on ONC know what this company has and the stored potential of this stock/company. You are at the ground floor of an opportunity in investing that comes once or maybe twice in a lifetime. The majority of you do not know it yet and posibly never will know how big this opportunity is.

This is a long race, you do not develop a cure for most cancers overnight. there are unsurmountable amounts of red tape by the goverment(s) they need to sort thru, there are tons of people trying to steal ideas, projects, data, etc. either to compete or destroy you. There are seas of tests, trials, re-tests, more trials, more testing, evaluations, studies, confirmations, etc. that a real company with a real product(s) must do if indeed they have "the cure for most cancers". You see, when you are real, fast cash and loose systems spell D I S A S T E R. THat is why ONC does not seem to most of you to be working fast enough.

Anyone on this board that owns 1000 to 2000 shares of this company will be a MULTI-MILLIONAIRE inside 6 years. Now, if you feel 6 years is to long to wait for your money to become millions, to bad for you, you will loose much when you sell. The people wanting a quick profit are probably suffering and waiting for news, and for the stock to go up a few bucks, etc. If all your money is tied up here on ONC, I understand your frustration but that only proves you are not a seasoned investor, you should either learn how to do it right or get out and put your money in a money market account or mutual funds !

You see the truth of the matter is that TIMING the MARKET or a COMPANY is almost if not impossible. The key has alway been and always will be TIME IN THE MARKET. The longer you spend invested, the more chances to profit you have.

ONC will make most of you MILLIONARES 5 times over. Don`t sweat the small stuff, forget about small steps here and ther and look at a 4, 5,6 year and beyond future. If ONC is 25% correct on their claims, you will still be a millionaire..... Why worry !

One day soon ( soon means 5 to 10 years) you will be enjoying the rewards of your fortitude and patience.

Thanks!


http://www.stockhouse.ca/bullboards/viewmessage.asp?no=69932…

[merx]

Hallo Muycaro,

auch ich hab ne Menge von den Dingern. Gestern war ein guter Tag zum Nachlegen. Hab leider die Gelegenheit verpasst. Naja wir gehn ja nach dem Motto:

" Short term pains for long term gains "

Vergleiche unseren Wert mal mit Genentech. Sollten die
Trials gut verlaufen, eine Partnerschaft angekündigt werden, wird bei den relativ wenig
Outstanding Shares, ca. 22 Mio, die Rakete zünden.

Gruß

m e r x

[muycaro]

Hier nochmal das gestrige Interview mit ONCY`s CEO zum nachlesen (Q= Frage, A= Antwort):

Transcript from Brad Thompson’s Interview on WorldTalkRadio (October 26, 2003)

Q: Can you give us an overview of Oncolytics Biotech?
A: Well, we’re an oncology company so all of our time and attention is focused on developing products for the treatment of cancer. And the specific technical area we are looking at is oncolytic viruses, ergo the company’s name. There are a number of viruses that either naturally, or through some minor genetic engineering can be directed towards selectively infecting and killing cancers in the body. The virus we are using is called the reovirus. It’s a very common virus. Anywhere between 70 and 100 % of any adult population you test have actually had evidence of being infected by it environmentally. And it’s a very benign virus and it looks like it has really good promise as a cancer therapeutic.

Q: So REOLYSIN is your lead product?
A: Yes it is. It’s a proprietary formulation of a naturally occurring virus. We haven’t genetically changed this virus at all – called the reovirus. REO stands for respiratory, enteric, orphan virus. Orphan viruses are a group of viruses that while they infect humans and reproduce in humans actually don’t cause any discernable illness in any way, shape, or form. While you most likely have had a reovirus infection some time in your life you won’t have ever gone to the doctor with it.

Q: So the reovirus with your technology essentially acts like a “judas goat” to get the damage done just to the cancer cells as opposed to the healthy cells?
A: Yeah, that’s a hallmark of all the approaches in this oncolytic virus area, including reovirus. The reovirus actually will infect any cell in your body. It’s what goes on inside the cell that the virus differentiates on. If it goes into a cell in what we call a state of RAS activation, which is just one of the division signaling pathways, if that’s turned on then the virus will replicate and in about 18 hours will actually kill the cell and spread progeny virus in the surrounding tissues. If it goes into a cell that’s normal the normal cellular metabolic processes degrade the virus. So you get this nice selectivity based on what’s going on inside the cell. It’s quite elegant and the fact that its designed that way by mother nature is kind of interesting.

Q: It is an elegant solution. So cancer cells have activated RAS pathways and you treat a patient with REOLYSIN, the reoviruses infect the cancer cells and cause the oncolytic effect.
A: That’s absolutely correct. It’s kind of interesting. Not all cancer cells are RAS activated. There are a number of other genetic changes that cause cancer, but a very large percentage of cancers are caused by that condition. It varies from cancer to cancer. If you get the more aggressive cancers, ones that are more likely to metastasize or spread beyond the primary tumor to other parts of the body, they seem to have a much higher percentage of RAS activation. Pancreatic cancer is an example. We’ve never found one that isn’t RAS activated. The more aggressive brain cancers – sort of in the 90+ % range – and things like some of the major carcinomas like non-small-cell lung, or prostate, or breast are all in sort of the two-thirds to 70% range, that actually have this condition. So what you have is a potential anyway to treat a very large percentage of most cancers that occur.

Q: Brad, can you tell us about Oncolytics’ agreement with the National Cancer Institute?
A: Well, the National Cancer Institute has been involved with an extremely high percentage of all the cancer products that have ever been approved. And they’re a very very good organization. Their involvement in your product allows you generally to broaden out the things that you are looking at clinically. I mean, Oncolytics’ core program is going to be looking at glioblastomas, the brain cancers, over the next year/year and a half, and a systemic administration study. That’s what we are going to be doing in-house. With the National Cancer Institute it allows us to broaden out to a much bigger number of clinical studies. We’re going to be looking at co-therapies with existing products, co-therapy with radiation, and looking at different specific cancers that we would not have looked at before. So it’s a real opportunity for us to gain access to expertise, and to gain access to a very very large system in the United States of clinical sites, as well as getting into cancers that we probably wouldn’t have done in this stage of our development.

Q: Has there been any work done with REOLYSIN vis-à-vis leukemia, or blood cancers, or lymphoma, things of this nature.
A: There’s been lab work done certainly, in the lab in animals. There’s a reasonably high percentage of lymphomas that appear to be treatable by this. The whole lymphoma, sort of blood-born, non-solid-tumor cancer area is a pretty exciting part of cancer development today. Our hope is that sometime, I mean there are so many different cancers that you could focus your time and attention on, but certainly the lab work would justify us taking a serious look clinically at lymphomas.

Q: The reason I bring that up is because those particular type of fluid based cancers, whether its lymph or blood, seem to be particularly intractable percentage wise versus the traditional treatments that are out there right now – chemo and things like that.
A: Chemo and radiation and surgery certainly are very important parts of the tool bag in cancer and will continue to be. I mean, we’re not going to be displacing surgery or radiation certainly in the near future. But their prime focus is more solid tumors. When you get the non-solid tumors, you know the lymphomas, or you get into metastatic disease where you’ve got little tiny tumor foci all through the body, these alternate approaches like the viral therapies I think could make a serious impact in that area.

Q: Brad, do you have a timeline for publishing your phase 2 data for prostate cancer?
A: Well, I keep annoying (I think would be a minor word) my investigator to get data so that we can publish it. And I think in the not too distant future, certainly sometime in 2004, I think you can expect to see that data coming out. The prostate study that we are running is a very technical study. T2 prostate cancer, as background, is very early. The prostate gland has two lobes and if it’s localized within one or both of those lobes it’s T1 or T2. When it metastasizes it goes on to T3 and higher. So this study is looking at very early stage cancer and it allows us to make sure that surrounding tissues are healthy. We spend a lot of time and attention focusing on killing tumor, but we’re also in this area spending a lot of time and attention demonstrating the safety and those elements of it. So we are looking into surrounding tissues to make sure they’re intact. We’re also looking for up-regulation of certain genes in the tumor, and we’re also looking for very specific types of tumor death. So it’s a reasonably technical study and I’m really looking forward to us publishing those results. I think they’ll be very interesting.

Q: You know, we bring up Calgary, Alberta, and we know you are involved in these clinical trials, how do you balance who you are speaking to in terms of the regulatory market? Are you pretty strictly aimed at the FDA and just hope that Canada comes along, or are there a different set of protocols and book keeping so you basically have to take your data and bifurcate it – one set for the FDA and one for the Canadian authorities?
A: Well, it even gets a little more complicated than that. Our initial studies were, and are, being run in Canada. Health Canada is a very different organization than the FDA. And we are also in the early stages of getting some studies up and running in Europe. And so you have three very different regulatory environments. Their issues and concerns with respect to manufacturing are all different, clinical protocols are all different, how they’re monitored are all different, and it gets a little bewildering. The parallel with that on the commercial side is we’re cross-listed on the Toronto Stock Exchange and on NASDAQ. Try balancing accounting standards across two countries, or we got ??????? in the States and we have equivalent but not the same kind of legislation in Canada. It gets a little strange. I’m a microbiologist by training, in infectious disease, and I never really thought I could sit down with securities lawyers or with clinical trial people and have these really detailed conversations. It’s a bit of a life change for me, I must say.

Q: How are you balancing the NASDAQ aspect, which obviously means you’re essentially in many ways accountable to American investors or people who invest through the NASDAQ, as opposed to the fact that you’re getting (at least at this point) your primary clinical data from Canada and Europe. How do you close the gap there for folks?
A: People like to invest in things that they can touch and feel and that are close to home. Increasingly our shareholder base is in the United States. I mean the majority of our shares, daily trading volume basis trade on NASDAQ, and that was part of the purpose of cross-listing on NASDAQ. Originally we listed in Toronto first and NASDAQ second. And so we’ve had a shift of our shareholder base, either through financings of just through trading, from Canada to the United States. And we actually have a pretty significant European shareholder base too which puts a third leg on that confusion. But people really like the next door thing and so from just a shareholder base issue it’s important for us to be running clinical studies in the United States. Secondly though, the United States is the world’s largest pharmaceutical market and if you’re going to pick a jurisdiction to focus your time and energy on, from a clinical development perspective when you’re looking towards future commercial sales, you have to be running clinical studies in the United States. We’ve just done the early stage work in Canada because it’s cost effective and we have a very good system in Canada for early stage development, and we thought when we hit the kind of trigger time it would be appropriate to switch so there would be some of our clinical effort out of Canada and in the United States, while still retaining some in Canada. We are in the process of doing that right now.

Q: Talking about investors and shareholder base can you tell us about Oncolytics’ management team and board of directors.
A: We’re a pretty distributed place. When we talk about Oncolytics being in Calgary there’s not a lot of Oncolytics in Calgary. We have our head quarters there and a number of our officers, but we have people in the United States and people sort of scattered around the planet now. We’ve been very fortunate with our management team. Matt Coffey is with me (he’s one who actually invented all this, and knows more about it than anybody that I know, and it’s certainly nice to have that continuity on there running your product development). We have Dr. George Gill, based down in the States, who actually came out of quasi retirement to work on this project. He runs our regulatory affairs side and he’s got a couple of dozen product approvals with the FDA under his belt with big pharma. That kind of experience is hard to find anywhere, and it’s just nice to have it located in the States. I have extremely good financial capability backup. My CFO worked actually in the transportation industry. He was CFO for an airline in Canada and is very broad based in that. So we have, I think, a pretty well-balance management team coming from a variety of different places. Try to extend that into your board of directors as well. We’ve a very active working board of directors. We’ve tried to balance that out with people from the investment banking side, people running biotech companies, people who work in big pharma, and legal. So we have a very very strong, very interactive working board (as a CEO often you wish they were a little less interactive).

Q: Very briefly give us a recap of the financials for the company. How much have you raised to date, what remains, what’s your burn rate, how many full-time employees do you have, and are you doing it all house, or are you contracting some things out?
A: Well we currently have a little over 20 million Canadian in the bank, accessible to us. And our burn rate is estimated over the next couple of years to be in the sort of $700,000 Canadian a month range. So we have cash that takes us into Q2 06, which is nice. We’ve been fortunate in being able to raise money. The key issue for us has been to ensure we had enough capital to reach all the critical milestones we are expecting in 04, and then having a cushion beyond that. We’ve never planned on taking this product into late stage clinical studies by ourselves. The plan has always been to get five or six early studies done and then partner up with one of the tier one oncology programs in the big pharmas, and then work on the product together beyond that. We just wanted to make sure that we had the financial resources, that we had the financial strength behind us that enabled us to go into those kinds of negotiations and discussions from a secure base. I think we’ve accomplished that.

Q: Yeah, so they can’t squeeze you.
A: Yeah, and they’re very good at that. I have a lot of colleagues in big pharma and they don’t like to pay any more than they have to for things, and if you’re running short of resources they’ll wait. Of course they will. That’s just good business, I applaud them for that. Then at least if you know that’s what they are planning on doing you can take steps to ensure that that won’t happen to you.
Q: Can you tell us briefly some milestones anticipated for 04?
A: I think in 04 people can expect to hear the conclusion of the data from our two ongoing studies – at least the T2 prostate cancer data should be out, and we should have the data from at least the phase 1 portion of the glioblastoma study, out and completed. The initiation of further clinical studies both in the United States and in Europe, and certainly much more texture on our NCI agreement and a real understanding of the number and types of studies we will be performing with the NCI.



Hier klicken zum anhören:

http://www.worldtalkradio.com/playlist.asp?SegmentID=3706



@merx

Nach den letzten PPs hat ONCY wenn alle Optionen ausgeübt werden (was nochmal mehr als $5 Mio in die Kriegskasse spülen würde, wobei sie es momentan ja offensichtlich nicht brauchen) knappe 29-30 Mio. shares outstanding (fully diluted).

Wobei es eigentlich egal ist, ob es nun 22, 25 oder 30 sind, wenn langfristig das passiert woran wir beide offensichtlich glauben, dann spielt das eine relativ geringe Rolle.

Schön ist das Cashpolster bis ins Jahr 2006 hinein. Wie Brad schon sagte, die BigPharma Boys mögen es wenn ihre potentiellen Vertragspartner im Entwicklungsbereich finanziell am besten ordentlich gesqueezed werden, weil keine grössere Cash Position bei den Verhandlungen den Rücken stärkt. ONCY kann warten, von daher wird es wohl sehr teuer für die Majors und ONCY hat einen umso besseren Hebel auf die Verkäufe je länger sie warten und je weiter sie das Produkt selbst entwickelt haben.

Denke auch wenn demnächst erstmal die Trials in Zusammenarbeit mit dem U.S. National Cancer Institute in den USA und Europa beginnen, wird dies für mehr Aufsehen sorgen (sowohl medizinisch, als auch pressetechnisch).
Wären wir ein US Unternehmen wäre ONCYs Marktkapitalisierung m.E. schon ein vielfaches von dem was uns als Kanadisches Unternehmen mit Nasdaq Listing (siehe Interview: mittlerweile hat sich unsere grösste shareholder base von Kanada in die USA verlagert, auch Europa wird erwähnt - das spricht für sich - die zunächst lokale Calgary Story verbreitet sich immer weiter).
Naja, ich finds eigentlich gut so wie es ist, denn so kann man sich umso mehr Aktien für den vorzeitigen Ruhestand bunkern...

So, ab heute ist ja erstmal Thanksgiving Time in den USA, von daher wird da nicht gehandelt, in Good Ole Canada allerdings schon.

Gruss an alle!

[merx]

Hallo muycaro,

vielen Dank für die Infobereitstellung.
Hoffe, wir können durch sachliche Info die Basis
für Oncolytics in Europa verbreitern.

Vielleicht wird Oncolytics mal ne AOL,YAHOO oder Microsoft.


Wait and see..................


m e r x

[muycaro]

Wie schon der weise Prophet von 21st Century Alerts zu sagen pflegte:

Getting in on this stock now will be like buying IBM in 1953 . . . McDonald`s in 1966 . . . Berkshire Hathaway in 1967 . . . Microsoft in 1985. This is the kind of stock you kick yourself for the rest of your life for passing it up when it was cheap.

[muycaro]

Ein weiteres ausstehendes Patent (neben ca. 100 anderen), das ich sehr(!) interessant finde:

METHOD FOR REDUCING PAIN USING ONCOLYTIC VIRUSES in my patents list
Inventor: MORRIS DONALD (CA); COFFEY MATTHEW C (CA); (+1) Applicant: MORRIS DONALD (CA); COFFEY MATTHEW C (CA); (+2)
EC: IPC: A61K35/76 ; A61P25/04 ; (+2)
Publication info: WO03094938 - 2003-11-20

This present invention relates to the surprising discovery that oncolytic viruses, in particular reovirus, can reduce pain associated with proliferative disorders, particularily with the growth of a solid tumour mass...........In the present invention, we demonstrate that virus administration resulted in diminished symptomsof direct tumour-associated pain. This lessening of pain occured both with and without actual tumour regression. Furthermore, there were no significant side effects or adverse effects related to the administration of the reovirus.

Based on our recent findings that intratumoral injection of reovirus is capable of causing tumour regression in a variety of animal models in Ras activated cells, a Phase 1 clinical study was conducted to examine any oncolytic effect of the virus in human patients with metastatic cancer that had failed to respond to conventional therapies. The trial established that the virus promoted tumour regression in a variety of solid tumour indications when iadministered intratumourally. Surprisingly, it was also noted that virus administration can result in diminished symptoms of direct tumour associated pain in this patient population. This lessening of pain has occured with or without actual tumour regression. In one instance the reduction of pain was sufficient to permit the patient to discontinue narcotic intake. Further, there were no reports of significant side effects or adverse effects related to the administration of the virus in these patients.

_______________________________________________

Reovirus scheint also nicht nur effektiv in der Tumorbekämpfung zu sein, sondern auch gegen Schmerzen, soweit dass ein Patient sogar seine Schmerzmittel absetzen konnte!

[muycaro]

Habe zwar schon mal etwas ähnliches gepostet, aber hier nochmal die Kurzform, da ich denke, dass dies die Wichtigkeit des Ras Pathways (Oncolytics Methode) in der Krebsbekämpfung validiert.


____________________________________________


Yale scientists trumpet cancer breakthrough

Abram Katz , Register Science Editor 10/10/2003

Yale scientists have discovered a way that cancer spreads, marking a breakthrough that could one day be useful in diagnosing and treating the disease.

Humans also carry Ras genes, which have been implicated in many forms of cancer.

If either the Ras or the polarity gene were normal, the cancer did not spread.

Why mutations in the Ras and polarity genes make cancer cells mobile is not clear.

However, researchers now have a potential target for drugs, he said.

"We would target Ras. Normal cells have normal Ras. Cancer cells have mutated Ras. All we need to do is kill the mutated Ras," Xu said.


http://www.newhavenregister.com/site/news.cfm?newsid=1029720…

[muycaro]

Example 1
Combination of Reovirus and Radiation Therapies

A 48 year old female patient had head and neck tumor (nasopharyngeal). There were three large lesions in the neck area, one on the right side,

one under the jaw, and the third on the left side. The one on the right side was the largest and covered almost from her ear to her shoulder.

The patient had been treated with chemotherapy and radiation therapy with either no effect or recurrence shortly after moderate response.

After chemotherapy and radiation therapy, the patient was treated with reovirus therapy. Thus, 1x10 9 Dearing strain reovirus was injected

into the left side lesion on Days 0,2,and 4 respectively. The reovirus was prepared as previously described (U.S. Patent Application

Publication No. 20020037576). The tumors were measured on Day 0 as the baseline level for each tumor. As shown in table 1, the left side

lesion and the lesion under the jaw measured about 4cm2 and 19cm2 respectively. The right side lesion was not measured as it was too large to

be measured meaningfully.

For other baseline measurements, blood was obtained from the patient to determine the presence of reovirus by reverse transcription polymerase

chain reaction (RTPCR) using reovirus specific primers. In addition, the titer of anti-reovirus neutralizing antibodies in the patient serum

was determined as well, which was performed by incubating diluted serum samples with a culture of l929 cells and reovirus. Whereas infection

of L929 cells be reovirus results in cytopathic effect (CPE) in the infected cells, CPE can be inhibited by anti-reovirus neutralizing

antibodies. Thus, the presence of neutralizing antibodies in the serum is indicated by inhibition of CPE in this assay, and the highest

dilution factor of serum that was capable of inhibiting 50% of the cells from developing CPE was deemed titer of the antibodies. As shown in

table 1, reovirus could not be detected by RTPCR on Day 0, and the level of anti-reovirus neutralizing antibodies was negligibly low.

Tumor size, reovirus and anti-reovirus antibodies were then measured periodically and the results are shown in Table 1. Both the left side

tumor and the lesion under the jaw continued to enlarge for a few weeks. However, on day 28, tumor measurements revealed that the lesion on

the left side (the injected site) decreased in size and was palpably softer. The lesion under the jaw was also reduced slightly.

The lesion

on the right side was too large to be measured accurately, but it appeared unchanged. Significant levels of anti-reovirus antibodies appeared

in serum after reovirus injection, indicating that reovirus replicated in the patient and was recognized by the immune system. Occasionally,

viral particles could even be detected in the blood by RT-PCR. Therefore, reovirus had spread beyond the injection site.

On day 50, the patient received radiation therapy to the right side tumor mass only using electron beams, at a tumor dose of 3000 cGy defined

at 100% isodose in ten daily fractions for 14 days. Surprisingly, visual assessment on Day 70 revealed that this tumor showed some shrinkage

even though the irradiation had been initiated for only 20 days. By Day 98, this tumor was reduced to about 10-25% of the baseline size.

Thus, reovirus is capable of sensitizing tumor cells to radiation therapy. This effect is not limited to the cells that have been contacted

directly with the reovirus, as the cells in the right side tumor mass were not injected with the reovirus. This phenomenon is consistent with

out previous observation that treating one tumor in a subject with reovirus can lead to reduction f another tumor in the same subject.

Furthermore, the lesion on the left side, which was injected with the reovirus but not irradiated, shrank to a quarter of the baseline size 20

days after irradiation of the right side lesion (Day 70), indicating that radiation and reovirus administration may induce a bystander effect

on each other. As another putative result of the bystander effect, the lesion under the jaw, which was neither in the radiation field nor

injected with the reovirus, shrank to a quarter of the baseline size on Day 98.

In view of these results, the combination of reovirus therapy and radiation therapy is a surprisingly effective treatment regime, and its

effect is not limited to the lesions that receive either reovirus or radiation. Instead, all tumors in the same subject, including metastatic

tumors, are inhibited by the combination of reovirus and radiation.

[muycaro]

Alles Auszüge aus den Patent Applikationen (hier zu dem Thema dass Reolysin offensichtlich schmerzstillend wirkt - letztes Posting über die Effektivität von der Kombinationstherapie durch Reovirus/Bestrahlung):

Beispiel 1:

Phase 1 Clinical Study:
Use of Reovirus for Reducing Pain Associated with Malignant Melanoma

A 54 year old female patient was suffering from a malignant melanoma, which formed multiple lesions (more than 10) over the whole body and

failed to respond to conventional anticancer treatments. The patient was permanently on narcotics due to pain associated with the lesion of the

left posterior neck.

The patient received three intratumoral injections of 10-9 pfu of the Dearing strain of reovirus serotype 3 into the lesion on the posterior

neck. The Dearing strain of reovirus serotype 3 used in these studies was obtained by a method disclosed in U.S. Patent Application Publication

No. 20020037576.

Surprisingly, one week following injection, the patient reported diminished pain at the treatment site and was taken off narcotics. There was

no pain at the treatment site during a 8-10 week period after the injection. As shown by punch biopsy conducted from the left shoulder after 2

weeks following the injection, there were no significant side effects or adverse affects related to the administration of the virus in the

patient. Histological results showed only some dermal fibrosis and mild perivascular chronic inflammation.


Beispiel 2:
Phase I Clinical Study:
Use of Reovirus for Reducing Pain Associated with Ewing`s Sarcoma

A 27-year old male terminal patient with Ewings`s sarcoma received a single intratumoral injection of 10-9 pfu of the Dearing strain of reovirus

serotype 3 into a sacroiliac site. The Dearing strain of reovirus serotype 3 used in these studies was obtained by a method disclosed in U.S.

Patent Application Publication No. 20020037576. One week following injection, the patient reported diminished pain at the injection site.

There was no pain at the treatment site during the next several weeks after the injection.

________________________________________________

Und das waren nur Dosen von dem 1/10 was eine Maus bekommen würde...

[muycaro]

Hier mal ein Link zur Datenbank des Europäischen Patentamtes, da könnt Ihr selbst mal etwas stöbern falls Ihr Lust habt - dies ist das Suchergebnis nach Oncolytics:

http://v3.espacenet.com/results?sf=a&FIRST=1&CY=ep&LG=de&DB=…

[muycaro]

In den Patentanträgen scheinen wesentlich mehr (ausserordentlich positiv überraschende) Einzelheiten zu finden zu sein, als bis jetzt durch News bekannt gegeben wurden.
Ich meine, dass Reolysin offensichtlich auch Schmerzen stillte oder Tumorzellen gegenüber zuvor fehlgeschlagener Bestrahlung sensibilisierte ist erstaunlich, wurde aber nie zuvor veröffentlicht.
Dies könnte etwas mit der vorherigen Absicherung durch Patente zu tun haben.

[schachi]

auf dem yahoo board hat sich einer die mühe gemacht eine längere unterhaltung mit brat thomson zu führen und eine zusammenfassung dsrüber zu erstellen.

ich gebe den link für die einführung hier an... ihr müsst dann im yahoo board die einzelnen teile anklicken

viel spass beim lesen... sehr interessant

http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

schachi

[muycaro]

Die Pressemitteilung von Oncolytics diesbezüglich ist ja schon eine Weile her, aber schön zu sehen, dass dies auch den Weg in Fachjournale gefunden hat:



Friday, December 12, 2003 Biotechnology company granted patent for Ras mediated tumor treatment
December 11, 2003 3:01pm
Health & Medicine Week

Oncolytics Biotech Inc. has been granted a patent covering the treatment of Ras mediated tumors using modified herpes viruses.

The patent is entitled "Viruses for the Treatment of Cellular Proliferative Disorders."

"We now have issued patents covering the treatment of cancers using three groups of viruses, including herpes, adenovirus and reovirus, that target the Ras pathway," said Dr. Matt Coffey, vice president, product development of Oncolytics.

"Herpes viruses having alterations in the (gamma)34.5 gene are commonly used in programs ranging from basic research to advanced clinical studies."

The issued claims in this patent cover the use of a herpes virus that has been modified by a mutation in the (gamma)34.5 gene, for the treatment of Ras-mediated cancers. This is believed to cause this virus to provide specificity in Ras-activated cancer cells.

Oncolytics is a Calgary-based biotechnology company focused on the development of Reolysin, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that in vitro the reovirus is able to selectively kill human cancer cells that are derived from many types of cancer, including breast, prostate, pancreatic and brain tumors. This article was prepared by Health & Medicine Week editors from staff and other reports.


©Copyright 2003, Health & Medicine Week via NewsRx.com & NewsRx.net

[muycaro]

Reuters
Merck trails in cancer fight, plans new effort
Friday December 12, 9:52 am ET
By Ransdell Pierson

NEW YORK, Dec 12 (Reuters) - Merck & Co. is the only large U.S. drugmaker that has developed no significant cancer drugs in recent decades and is testing none in current human clinical trials, a shortcoming industry analysts say has hurt the company`s prestige and earnings prospects.

Merck (NYSE:MRK <http://finance.yahoo.com/q?s=mrk> - News <)" target="_blank" rel="nofollow ugc noopener">http://finance.yahoo.com/q/h?s=mrk>) research chief Peter Kim said earlier this week the company is looking forward some day to having a "substantial program in oncology," but acknowledged no studies of its possible cancer drugs have progressed beyond the petri dish or animal-testing stage.

"A scientific explosion has occurred in understanding oncology and what allows a tumor to be maintained," said Kim, who took the helm of Merck`s research labs nearly a year ago. He spoke at a meeting with industry analysts to review the company`s pipeline of experimental medicines.

Merck launched a leukemia drug called Elspar in 1970 and a product called Cosmegen for rare types of cancer in 1965. And it introduced an anti-vomiting pill this April for patients on chemotherapy, which had negligible third-quarter sales.

By contrast, rival U.S. and European companies have steadily produced major cancer-related drugs that racked up sales of $32 billion last year, a number that will zoom to $61 billion by 2007, according to SG Cowen.

Kim did not predict when the world`s No. 3 drugmaker will deliver new cancer treatments, but said they will come from Merck laboratories and through partnerships with other drugmakers, such as its deals this year with GenPath Pharmaceuticals Inc. and and Alnylam Holding Co.

Cancer is the second-biggest cause of death in the United States. The number of newly diagnosed cancer cases -- now about 1.3 million a year -- is expected to rise with the aging population and better screening techniques.

"This is clearly a big area and Merck is in a weaker position than any major rival," said Gordon Carey, senior vice president of Cambridge Pharma Consultancy.

Newer cancer drugs like Novartis AG`s (NOVN.VX) Gleevec and Genentech Inc.`s (NYSE: DNA <http://finance.yahoo.com/q?s=dna> - News <)" target="_blank" rel="nofollow ugc noopener">http://finance.yahoo.com/q/h?s=dna>) Rituxan hit specific molecular targets linked to cancer and thereby cause milder side effects than standard chemotherapy.

Such targeted therapies, which typically cost $5,000 to $25,000 per year, are expected to be mainstay treatments in the next decade. And another 200 cancer products are now in clinical development -- the most active area of pharmaceutical research.

Carey said Merck`s limited record against cancer is "ironic" given that its recently retired research chief, Edward Scolnick, had been one of America`s most noted cancer experts when he was hired to oversee Merck`s labs 18 years ago.

Sam Islay, managing partner of investment firm OrbiMed Advisors, said it would take Merck many years to develop its own cancer drugs. To become a significant player, he said Merck will have to pay ever-increasing fees to license or co-market cancer drugs developed by other companies.

"The cost of obtaining rights to a cancer drug even in the earliest stages of development is now about $125 million, triple what it would have cost three years ago," Isaly said.

Many promising early-stage drugs have already been licensed to other companies, so competition for other desirable products will likely boost the price of future partnership deals, Isaly said.

Merck expects its earnings to decline this year due to generic competition for its treatments for hypertension, ulcers and high cholesterol and the company`s inability to launch any big new drugs since 1999. So its budget for cancer-drug partnerships could be limited.

Cambridge Pharma`s Carey said he has no doubts that Merck is serious about developing cancer drugs.

"Merck has been overtaken in recent years as the top dog in the drug industry because its innovation and number of new products has slipped," Carey said.

"Oncology is a major new focus because they probably see it as one way of taking them back to the No. 1 spot." (Additional reporting by Jed Seltzer)

[muycaro]

Ein interessanter Artikel bezüglich der offensichtlich erfolgreichen Behandlung von Hautkrebs durch Viren in Australien.

________________________________________________________

Cold virus may be skin cancer cure
Wednesday, January 7, 2004 Posted: 0636 GMT ( 2:36 PM HKT)


SYDNEY, Australia (CNN) -- Researchers at an Australian university believe they have developed a breakthrough showing skin cancer can be stopped by the common cold virus.

Skin cancer, or melanoma, is the fifth most common form of cancer.

Australia has the highest rate of melanoma in the world, with one out of every two people likely to develop some form of the disease during their lifetime.

A team led by Professor Darren Shafren at the University of Newcastle, about 150 kilometers north of Sydney, have established that malignant melanoma cells can be destroyed by infecting them with coxsackievirus, the common cold virus.

Their work is to appear in the January 2004 edition of Clinical Cancer Research, a journal of the American Association for Cancer Research.

"We believe this is a significant breakthrough in the development of the treatment of melanoma," Dr Shafren said in a statement released by the university Wednesday.

He said the results achieved so far using human cells and in animal studies had been "very exciting".

"If we can replicate that success in human trials, the treatment of this often fatal disease could be available within the next few years," he said.

Dr Shafren said the team believed the treatment could even be effective for people with advanced melanomas.


Shafren believes the team has made a breakthrough in treating skin cancer.
According to the university researchers, the projected process begins by injecting the common cold virus into a melanoma. The virus replicates itself and then, according to the projection, begins killing off the melanoma.

Within weeks, there is a reduction in the size of the melanoma and it eventually disappears.

When the secondary action begins, the team expects the virus to circulate through the body, finding and killing off melanomas. The effect is that the virus will seek and destroy melanomas that may be undetectable.

Dr Shafren noted that the coxsackievirus was not a manufactured drug or a genetically altered virus. Instead, it was a virus that occurred in the community.

"Viruses are seen as unhealthy organisms but we have identified a potential way they can be used by the body to fight and destroy disease," he said.

About 1000 Australians die from melanoma each year, and about 300,000 visit a doctor to have a skin cancer removed.

________________________________________________________


Viren, vorallem genetisch unveränderte, rücken offenbar immer mehr ins Rampenlicht des Interesses in der Forschung zur Krebsbekämpfung und Oncolytics ist an vorderster Front mit dabei. Bin mal gespannt wann die NCI Trials in den USA beginnen.

Viele Grüsse, muycaro

[muycaro]

Wobei ich zu dem australischen Forschungen noch anmerken muss, dass die erst Versuche im Frühstadium mit menschlichen Zellen, bzw. Tieren waren. ONCY ist ja bekanntlich schon einige Schritte weiter.

[muycaro]

Interessant - ein Beitrag eines kanadischen Analysten zum Thema Risikomanagement bei spekulativen Investments (schon überraschend, dass er plötzlich auf ONCY zu sprechen kommt und ausserdem was er dazu sagt):



Jan 22 2004 14:47:00 - Source: BUS [The Canadian Press]

Weekly Money Monitor (Money-Monitor)
By Malcolm Morrison

TORONTO (CP) _ All investing involves speculation. One of the tough parts is balancing one`s tolerance for risk versus the amount of money expected from investments.

Beyond that, investors sometimes want to allocate a small part of their portfolio _ maybe 10 per cent _ for the extremely speculative. That would involve stocks with a higher risk than, say, a blue-chip company like media giant BCE Inc. along with the prospect of much more lucrative returns.

But even many of today`s most respected, conservative companies looked risky in their youth.

``IBM was a speculative stock at one point. They had to start from somewhere,`` observed Gedd Cantwell, branch manager and a vice-president of National Bank in Calgary.

``You could take Microsoft in the 1970s, take Yahoo in the `90s, they were speculative. But guess what? They had something.``

If you want to ratchet up your level of risk in hopes of higher returns than eight or nine per cent, remind yourself about what taking a bigger chance entails.

``It is not uncommon for a client to say, `I don`t mind risk. I`m OK with high risk,``` said Brendan Caldwell, president of Caldwell Securities.

``If you want better than a risk-free return, it means you will have to take some risk. It doesn`t mean though if you take more risk that you`re going to get a better than risk-free return. That`s what the word risk means.``

Finding the right stock to invest in can be tricky. As usual with any investment, do some homework on the company you`re interested in and don`t substitute cheap chatter for an objective view of the company.

``If you`re getting it second-, third- or fifth-hand, chances are this thing has already made a move or it`s not going to make a move,`` said Cantwell.

Just because you want to try a speculative play or two, it doesn`t mean you`re restricted to junior oil and gas companies or stocks typically trading below $1, which is where a lot of speculative money ends up.

``You could, perhaps, still go with Nortel Networks (TSX:NT),`` said Caldwell, noting that Canada`s biggest high-tech company is still down well over 90 per cent from its old highs.

``We used some Zarlink Semiconductor (TSX:ZL). It`s one that`s down on its luck and hasn`t had a huge bounce yet. You could look in the industrial sector _ Bombardier (TSX:BBD.B), down and out, nobody loves it.

``CAE (TSX:CAE) is similar, a company ... down because of the airplane issues. Went up to $16, went down to $5. There`s a lot of these fallen angels which have in the main, I think, stopped falling.``

Looking at survivors from the tech wreck of 2000 also appeals to Cantwell, who advised a look at Sun Microsystems (Nasdaq:SUNW) ``because they`ve revamped their server line, they have turned around.``

``I would pick Sun any day of the week because if nothing else they will be in business and they have a product people like. You don`t have to speculate on BS plays.

Health stocks are also worth investigating.

``Look at **>Oncolytics<** Biotech Inc (TSX: ONC),`` said Cantwell. The Calgary-based company is focused on the development of its **>Reolysin<** drug as a potential cancer therapeutic.

``It`s an interesting story, up and down like crazy, highs of $6.50, lows of $1.50. Highly speculative. It`s incredible how this thing trades. But if it gets what it wants, what it`s looking for, this thing has an absolute possibility to be hundreds of dollars a share.``

Unless you`re an experienced investor, you might want to make your speculative plays through the mutual fund route rather than individual stocks.

A Canadian resource mutual fund can balance your risk since if you have a basket of stocks. The chances are you still get a decent profit even if the other ones don`t become a success story.

Since the risks _ and potential rewards _ of investing in speculative stocks are greater, investors can have a tough time controlling emotions.

``You leave yourself vulnerable``, said Caldwell. ``So if you`re able to think objectively about your emotions, OK. (Ask yourself You own a stock and if this thing goes to zero, how am I going to feel?``

[muycaro]

Vielleicht habt ihr es ja schon gesehen, Oncolytics haben ihre Webseite neu gestaltet:

http://www.oncolyticsbiotech.com/

Ich finde sie sieht jetzt freundlicher aus und sowohl Navigation als auch Struktur wurden verbessert.

Hier nochmal eine Übersicht über die klinischen Versuche, die sich derzeit auf dem Weg befinden:

http://www.oncolyticsbiotech.com/clinical.html#Phase1

ONCY wurde übrigens am Wochenende mit dem zuletzt von mir geposteten Artikel in diversen kanadischen Tageszeitungen erwähnt.

Ich denke es stehen mal bald wieder ein paar news an nach dem jetzt doch schon etwas längerem "blackout".

Viele Grüsse an alle, die darauf hoffen, dass ONCY eines Tages die Behandlung einer der schlimmsten Geisseln unserer Zeit revolutionieren wird.

[muycaro]

Wenn ich mir den Auszug aus der Patentschrift (siehe Beitrag Nr. 74 in diesem Thread) nochmal genau anschaue kommt mir gerade so ein Gedanke:

_________________________________________________

Use of Reovirus for Reducing Pain Associated with Malignant Melanoma

A 54 year old female patient was suffering from a malignant melanoma, which formed multiple lesions (more than 10) over the whole body and

failed to respond to conventional anticancer treatments. The patient was permanently on narcotics due to pain associated with the lesion of the

left posterior neck.

[...]

Surprisingly, one week following injection, the patient reported diminished pain at the treatment site and was taken off narcotics. There was

no pain at the treatment site during a 8-10 week period after the injection.

________________________________________________

Denkt Ihr, dass die längere Phase des Schweigens bzgl. ONCY vielleicht damit zu tun hat, dass sie bemerkt haben, dass Reolysin während es die Krebszellen attackiert und vernichtet auch die Schmerzen des Patienten lindert und das Management aus diesem Grund möglicherweise noch damit beschäftigt ist sich die Rechte in diesem Bereich zu sichern?

Ich bin auch schon mal gespannt, wann die erste Ankündigung bzgl. der Versuche mit dem US National Cancer Institute kommt.

[merx]

Hallo Jungs und Mädels,

kommt wieder Schwung in die Bude..........


10% und sie steigt und steigt.............


long and schrtong........


oncy gooooooooooooooooooooooooooooooooo


merx

[muycaro]

Vielleicht haben einige nochmal ihre alte Zeitung vom 27.01. vorm verfeuern durchstöbert und sind dabei hellhörig geworden:


Health stocks are also worth investigating.

``Look at **> Oncolytics< ** Biotech Inc (TSX: ONC),`` said Cantwell. The Calgary-based company is focused on the development of its **> Reolysin< ** drug as a potential cancer therapeutic.

``It`s an interesting story, up and down like crazy, highs of $6.50, lows of $1.50. Highly speculative. It`s incredible how this thing trades. But if it gets what it wants, what it`s looking for, this thing has an absolute possibility to be hundreds of dollars a share.``


Und der Mann muss es schliesslich wissen, ist doch Analyst...

...und noch dazu einer, dem ich zustimme...

[muycaro]

Irgend etwas durchgesickert, oder werden grössere Adressen langsam aufmerksam?

[muycaro]

Sieht auch irgendwie nach Verkäuferstreik aus...

[muycaro]

Ganz schön harter Pullback hier. Naja, wenigstens ist etwas Volumen reingekommen und man hat nochmal die Chance sich zu positionieren.

[muycaro]

United States Patent Application 20040029112
Kind Code A1
Thompson, Bradley G. ; et al. February 12, 2004

--------------------------------------------------------------------------------
Oncolytic viruses as phenotyping agents for neoplasms


Abstract
The present invention provides a method of diagnosing neoplasms having a particular phenotype by using oncolytic viruses that selectively replicate in neoplasms having the particular phenotype. For example, reovirus does not replicate in normal cells. However, reovirus selectively replicate in cells with an activated ras pathway, which leads to death of these cells. Therefore, a cell which becomes neoplastic due to, at least in part, elevated ras pathway activities can be diagnosed by its susceptibility to reovirus replication. This invention can further be applied, using other oncolytic viruses, to the diagnosis and/or treatment of other tumors, such as interferon-sensitive tumors, p53-deficient tumors and Rb-deficient tumors. Kits useful in the diagnosis or treatment disclosed herein are also provided.


--------------------------------------------------------------------------------
Inventors: Thompson, Bradley G.; (Calgary, CA) ; Coffey, Matthew C.; (Calgary, CA)
Correspondence Name and Address: BURNS DOANE SWECKER & MATHIS L L P
POST OFFICE BOX 1404
ALEXANDRIA
VA
22313-1404
US


Assignee Name and Adress: Oncolytics Biotech Inc.
Calgary
CA


Serial No.: 602024
Series Code: 10
Filed: June 24, 2003

U.S. Current Class: 435/5
U.S. Class at Publication: 435/5
Intern`l Class: C12Q 001/70

[muycaro]

Hier nochmal die Erklärung des Patentes durch einen qualifizierten Yahoo Poster mit wissenschaftlichem Hintergrund in diesem Bereich:



Re: New US published patent
by: matdu1 02/12/04 09:20 am
Msg: 9494 of 9494


Traditionally, cancers are classified in terms of organs and tissues, e.g. breast, prostate, skin etc. Treatments of cancers have relied heavily on chemicals, among others, that target fast growing cells. The key problem with that approach is the serious toxicities associated with these toxic compounds. Futhermore, this wholesale approach to the often heterogeneous cancer masses result in low overall success rates and high toxicities. With the advances in molecular biology and genomics, more are now known about the molecular causes and anomalies of different types of cancers. New approaches focusing on these specific molecular targets are being developed. One such example is the use of Reolysin in killing Ras-activated cells that are common among a high % of cancers.

The classical chemotherapy approach is like going to buy a suit at Sears off the rack. Chances are that these suits would only fit a small % of the people well, while they don`t look that good with the majority of the population. OTOH, the target-specific approach (like Reolysin), is like going to a tailor to have your suit made to fit you. Before your tailor can make the suit, he/she needs to know more about you and to do some measurements on you so that the resulting suit would fit you as well as possible. What this patent describes are the different ways to do such "measurements" for the cancer patients before the best decision can be made to treat the cancers.

Cancer biopsies can be obtained and then infected with a variety of viruses that exhibit specificities in infecting cells with certain defined mutations/defects. As an example, biopsie samples may be infected with Reolysin in the lab to see if they are susceptible to reovirus in an ex-vivo setting. If the answer is yes, then you would expect Reolysin would have similar lytic effect on the cancer patient. This same approach can be performed with other viruses that target p53, RB or IFN. With a series of such tests, oncologists may then decide on what treatments, as mono- or combination therapies, would yield the best results.

In short, physicians would try to understand more at the molecular level the cause of the cancers before applying the appropriate treatments. As a result, cancer treatments will become less toxic and more effective than the old one-size-fits-all chemotherapies.

Posted as a reply to: Msg 9490 by guidanceplease


Wünsche allen viel Glück und noch eine erfolgreiche Woche.

P.S.: Imclone`s Erbitux wird möglicherweise in den nächsten Tagen durch die FDA zugelassen, das sollte sich positiv auf den Sektor auswirken.
Falls Ihr noch eine Portfolio-Beimischung im Bereich Biotech/Krebsbekämpfung sucht, schaut Euch mal Dendreon (NAS: DNDN) an. Sind nicht mehr wirklich so günstig und schon ziemlich stark gelaufen in letzter Zeit, sehe hier allerdings trotzdem noch ein gutes Potential (nicht so gross wie bei ONCY, aber immerhin). Evtl. mal bei Pullbacks (so wie heute morgen in FRA) zuschlagen (siehe DNDN Thread von motzi).

[muycaro]

Eines noch:
Die Institutionelle Beteiligung an ONCY steigt langsam aber stetig, siehe:


ONCY Oncolytics Biotech, Inc. Nasdaq-SCM

Ownership Summary Description

INSTITUTIONAL
Total Number of Holders 7

% of Shares Outstanding 5.85%

Total Shares Held 1,591,334

Total Value of Holdings $6,078,896

Net Activity 66,901


Top 5 Holders Shares Held


MELLON BANK N A 1,348,880

ONTARIO TEACHER... 150,000

BANKMONT FINANC... 67,974

MWN LTD 12,875

PALO ALTO INVES... 10,000


http://www.nasdaq.com/asp/Holdings.asp?mode=&page=&symbol=ON…
______________________________________________________

Mellon hat nochmal nachgelegt andere auch.

[muycaro]

Imclones Erbitux wurde in den USA durch die FDA zugelassen, obwohl es keine eindeutigen Anzeichen für eine verlängerte Lebenserwartung der Patienten gegeben hat (Tumore schrumpften jedoch).
Ausserdem hatte ein sehr hoher Anteil der Behandelten mit Nebenwirkungen, wie starkem Hautausschlag und einer schweren Lungenerkrankung zu kämpfen:


BIOTECH REPORT

ImClone shares rebound
Earlier plunge remains mystery, SEC reviewing trades
By Ted Griffith, CBS.MarketWatch.com
Last Update: 9:46 AM ET Feb. 13, 2004


BOSTON (CBS.MW) -- Shares of ImClone Systems soared back in Friday trading, reversing a mysterious plunge in the previous session that preceded news the biotech firm`s Erbitux cancer therapy had won long-awaited U.S. approval.

ImClone (IMCL: news, chart, profile ) shares were changing hands at $45.70, up $11.70, or 34.4 percent, from $34, the level where shares were halted on Thursday. The shares recovered all the lost ground and then some from the still unexplained swift tumble the day before.

As expected, federal regulators on Thursday approved ImClone Systems` Erbitux drug for the treatment of colon cancer. But the day was not without controversy -- familiar territory for the biotechnology firm that has been at the center of an insider-trading scandal involving Martha Stewart.

Just before the Food and Drug Administration`s decision was announced in the afternoon, ImClone shares plummeted $9.10, or 21.1 percent, to $34 and were then halted on Nasdaq through the remainder of the regular trading session. Shares bounced back after reopening in the after-hours session, trading to close to $45.

The Securities and Exchange Commission and regulators at the NASD will review trading in ImClone just before the halt, a Nasdaq spokeswoman said. She called such a review "customary." Trades made before the halt at 1:34 Eastern time are expected to stand, according to the spokeswoman.

It wasn`t clear why shares plunged, but it`s possible some investors were acting on a false rumor that the drug would be turned down again by the Food and Drug Administration. The FDA rejected the first Erbitux marketing application back in late December 2001, citing insufficient data submitted by New York-based ImClone.

"The size of the drop almost makes it look like somebody didn`t expect Erbitux to get approval," said analyst Howard Liang, who follows ImClone for JMP Securities.

Commercial potential

Liang said he considered the Erbitux approval to be better than expected because the drug was cleared for use on its own, so-called monotherapy. The FDA, as expected, also OK`d Erbitux for use in combination with another anti-cancer drug, irinotecan. Liang said approval for Erbitux may also ultimately be expanded to include the treatment of lung cancer.

ImClone`s pharmaceutical partner, Bristol-Myers Squibb (BMY: news, chart, profile), will market the drug in the United States.

Bristol-Myers shares slipped 49 cents to $29.40.

Liang said he expects Erbitux to have U.S. sales of $122 million in 2004. He said that sales in colon cancer alone could eventually reach $800 million annually.

Analysts` estimates on Erbitux`s commercial potential vary, but some have predicted sales could top $1 billion, if the drug is OK`d to treat several cancer types. Bristol-Myers and ImClone haven`t provided sales projections.

Colon cancer is the third leading cause of cancer death in the United States, and about 148,000 Americans are diagnosed with the disease every year, according to statistics cited by ImClone and Bristol-Myers.

Erbitux will face competition from drugs already on the market as well as others expected to be launched soon. Genentech (DNA: news, chart, profile ), the world`s No. 2 biotechnology firm, is expected to win clearance no later than next month for Avastin, a colon cancer therapy that`s expected to be used more broadly than Erbitux.

Manufacturing snag?

Manufacturing concerns may have cast a shadow on the approval. ImClone and Bristol-Myers, which is also based in New York, acknowledged that use of ImClone`s manufacturing facility will be held up while the FDA evaluates additional information submitted about the plant in Branchburg, N.J.

For the time being, ImClone and Bristol-Myers will sell a supply of the drug made by contract manufacturer Lonza. ImClone and Bristol-Myers said Erbitux will be commercially available in the United States within two weeks.

Kathy Baum, a spokeswoman for Bristol-Myers, said her company is optimistic that manufacturing will not be an obstacle. The FDA has four months to decide whether to OK the New Jersey facility.

Hemant Shah, an independent pharmaceutical analyst, said he doesn`t expect manufacturing will be a major problem. Shah said he considered the FDA`s blessing of Erbitux to be a major victory for ImClone and Bristol-Myers. Shah said he holds shares of both companies.

"This was a 180-degree turnaround from what we saw more than two years ago," Shah said. "Erbitux was approved with a broader indication than we could have hoped for."

Comeback

For both Bristol-Myers and ImClone, the approval marks a successful end to an effort to revive the Erbitux marketing application, which had a disastrous start at the FDA.

"Over the last several months, we`ve kept our eyes on getting this drug to patients and we`re pleased that`s finally happening," Baum said. "Today is a good day for colorectal cancer patients and it`s a good day for our company."

ImClone officials didn`t return calls seeking comment.

On their first attempt to get Erbitux approved, ImClone and Bristol-Myers stumbled badly. The FDA in late 2001 rejected the initial Erbitux application, sending ImClone shares plunging and triggering a major insider-trading scandal.

Sam Waksal, ImClone`s founder and then-CEO, was accused of tipping off relatives about the FDA setback so they could unload ImClone shares before the news became public. Waksal later pleaded guilty to numerous charges of securities fraud and is serving a sentence of more than seven years in federal prison.

Martha Stewart, a friend of Waksal`s, also drew scrutiny with her decision to sell ImClone shares just before the bad news was announced. By coincidence, the FDA`s decision to approve the revised Erbitux marketing application comes at a time when Stewart is on trial for allegedly misleading investigators about her sale of ImClone shares. Stewart has maintained her innocence.

`Gum in a lock`

The FDA approved Erbitux to treat advanced colon cancer that has spread to other parts of the body. Erbitux is the first biotech antibody-based drug approved to treat this type of cancer.

The drug, which grew out of research done more than 20 years ago by Dr. John Mendelsohn, is designed to work by interfering with the biochemical signals that fuel cancer`s deadly spread in the body. Mendelsohn has said in the past that using Erbitux on cancer is analogous to "sticking gum in a lock" because it inhibits cancerous cells from getting the growth signals.

But Erbitux is by no means a cure for cancer. Indeed, FDA officials said there is no clear evidence yet that Erbitux extends the lives of patients. They did say the drug has been shown to shrink tumors, which can be an indicator that a medication will help cancer patients live longer.

Patricia Keegan, the FDA`s director of the division of therapeutic biological oncology products, said additional data from clinical trials now being conducted should show what effect Erbitux has on survival.

"The fact that it`s an effective therapy for tumor reduction is in itself a benefit to patients, or likely to be a benefit to patients," Keegan said during a conference call with reporters. "Whether it prolongs survival, we can`t tell yet."

The FDA also said that Erbitux, like all drugs, has side effects. The agency said that rare cases of a serious lung condition had been reported in patients who received Erbitux. But it`s not known whether the drug caused the condition, called interstitial lung disease, the agency added.
Ted Griffith is a reporter for CBS.MarketWatch.com

______________________________________________________

Wenn man bedenkt dass bei Reolysin bis heute praktisch keine nennenswerte Nebenwirkungen aufgetreten sind (ausser leichte Grippesymptome unmittelbar nach der Injektion), egal bei welcher Dosierung und dass einige der Patienten aus Phase I mit einer durchschnittlichen Lebenserwartung von 3 Monaten nach eineinhalb Jahren immer noch leben, ist dies m.E. beeindruckend.

Und wenn die FDA schon dem umstrittenen Erbitux die Zulassung gibt...

Naja, wir wollen ja auch nicht zu sehr Äpfel mit Orangen vergleichen.

P.S.: Hatte Euch letztens ja noch DNDN ans Herz gelegt - heute neues 52 Wochenhoch! Deren Medikament Provenge ist derzeit kurz vor komplettierung von zwei Phase III Studien für Prostatakrebs. Bei Provenge wurde bis jetzt eine Verlängerung der Lebenserwartung von 89% beobachtet.

[muycaro]

FDA Sees Rebound in Approval of Innovative Drugs in 2003
New Innovation Initiative Anticipated to Speed Approvals in Years Ahead:

http://www.fda.gov/bbs/topics/NEWS/2004/NEW01005.html

Hört sich ja ganz nach einer "neuen FDA" an.

[merx]

hey muycaro,

in Canada hat ein gewisser Curtis im Laufe des Jahres 2003
1.687 Mio shares verkauft. Manche böse Zungen behaupten:
There are many red flags ?????

Was meinst Du dazu ????


Gruß

merx

[muycaro]

Hallo merx,

meines Wissens war Curtis einer der Gründer von Transition Therapeutics (V.TTH) und hatte die Aktien von Oncolytics im Zuge eines Share-Swaps von Oncolytics (die sich damals wohl eine etwas diversifiziertere Entwicklungs Pipeline aufbauen wollten) und den Gründern von TTH bekommen.

Da die Oncolytics Aktien gute Kursgewinne verzeichnen konnten, hat er wohl einen guten Schnitt gemacht (seine Motive für den Verkauf kenne ich nicht, aber wie sagt man so schön: nothing wrong with taking profits, right?).

Oncolytics haben ihre TTH Aktien auch wieder veräussert.
Ich sehe das eigentlich eher positiv, denn diesen "Overhead" an zum Verkauf stehenden Aktien haben wir somit schon abgebaut.

Auf der anderen Seite sehe ich die Institutionellen Anleger, die sehr(!) langsam, aber sicher auf ONCY aufmerksam werden (beobachte Insti. Holdings Summary von Monat zu Monat).

Ich meine auch in der letzten Zeit waren Auffälligkeiten beim Handel von Oncolytics Aktien zu beobachten, vielleicht stockt da immer noch jemand auf (vielleicht auch nicht - wird sich demnächst zeigen).

Ich bin mal auf die nächsten Meldungen gespannt - langsam wird es Zeit. Aber meistens kommt ja dann was mit dem man nicht gerechnet hatte (siehe Ankündigung NCI Collaboration).

Schönes Wochenende

[muycaro]

Also "Red Flags" sehe ich eigentlich keine, nur dass ich gerne mal wieder ein Update des Progresses hätte.

Was mich eigentlich sehr bestärkt ist immer noch, dass das US National Cancer Institute auf ONCY zugekommen ist (nicht umgekehrt). Oncolytics spart so Millionen von Dollar und ohne dass das NCI beeindruckt gewesen wäre, hätten sie diesen Schritt m.E. ebenfalls nicht getan.

Die nächsten Meldungen die ich erwarte beinhalten unter anderem neue Patente (jederzeit), Prostate Ph. II Results, Glioma Ph. I Results und irgendwann gegen Mitte/Ende des Jahres die Ankündigung der Aufnahme der NCI Trials.

[merx]

Hey muycaro,

danke für Deine informativen Auskünfte. Time will tell.

Gruß

merx

[muycaro]

Nichts zu danken.
Mal sehen was die nächsten Wochen, Monate so bringen.

Viele Grüsse

[muycaro]

#100 (Jubiläum sozusagen)

Bezüglich der Erbitux Zulassung und deren Auswirkung auf andere Unternehmen/Zulassungsverfahren in diesem Sektor nochmal die Meinung eines Posters auf einem US-Board (SCLN), die ich interessant fand, und der ich überwiegend zustimme.
Deshalb möchte ich sie hier nochmal für Euch reinstellen:

___________________________________________



First, to ward off the idiots, I never said I would stop posting. I said I would cut back. And I am. But there is news to great that NONE of you have latched on to (friends need to know)...and a I hate the "slap bitch" type shorts/posts, more than I dislike the "usual cadre". This may be a 2 prong post.

What happened yesterday in Imclone with Erbitux is a tsunami shift in FDA thinking. Yesterday, the FDA threw aout almost all it`s old rules. It is indeed a new day at the FDA. I posted that we should watch IMCL and Erbitux a while ago, lookning for a "kinder and gentler" FDA would help all biotechs. Forget "kindler/gentler"...it is now a wide open game. Why I say this?

Yesterday, the FDA approved Erbitux for colorectal cancer. Erbitux did NOT extend patient survival rates. You still DIED! All Erbitux did - and the FDA stated this VERY carefully in it`s release:

1. In mono application, Erbitux showed a response rate of 10.8%...where in 10.8% of patients, there is evidence of the cancer tumor shrinkage. But it does not extend mortality/death rates.

2. In a combo application of chemotherapy, Erbitux did not extend patient mortality, and 22% of patients showed a shrinkage of tumors.

Do any of you grasp the significance? If not. I will re-phrase what the FDA approved. The FDA just approved Erbitux where it is shown that Erbitux does not extend any patients mortality/death rate. Further in tests, the FDA stated that 90% of patients will not see any shrinkage of their tumor when using Erbitux in mono!!!!. Repeat! 90% of patients DO NOT see ANY shrinkage of tumor...and Erbitux takers still die! THE FDA APPROVED THIS DRUG! It only got 10% in mono!

NOW do you all get it? Have you any grasp at what the FDA has done? What the FDA has done now is set the bar slow low that it could open the floodgates for many drugs that never would have tried to approve. The FDA did this for a CANCER drug...it is yet to be seen if they will approve other indications with only a TEN PERCENT response rate. My guess they will.

Now, literally a year or so ago...there was an understood "rule" for FDA approvals and evaluation of you own trials. The FDA wanted to see "Statistically Significant" results of efficacy. How did the FDA measure that? Easy. The fools at FDA simply decided that to reasch "statistical significance", there MUST be at least a 25% response rate in whatever drug you are trying. 25% was the "Trial Bar" set by the FDA. 10% was where the "Trial Bar" was lowered to yesterday. Now, hark back to 1994 & SCLN? What was the result of Zadaxin in that supposed failed trial? Zadaxin got a mono response rate SVR...of 24%!!!. But the Street deemed Zadaxin a failure because it did not reach the magic 25% demanded FDA threshold. Even though it appears that one of the three sites mixed up placebo vs Zadaxin.

So you see, friends and enemies, what the FDA did yesterday was set a huge & binding precident. They approved Erbitux at 10% response rate. Now, all any applicant who has a lower than 25% response rate merely, has to point to the precident setting FDA case of a 10% response rate Erbitux (and the FDA says they still die.). They will state why they should get approved because of the "Erbitux Decision". Just like courts may now quote decisions like "Miranda" or "Brown vs Board of Education". What is the FDA gonna say? The FDA has put themselves in a real bind now. What they did yesterday was switch from an ARBITRARY 25% figure...to one where the FDA approved on safety and was there ANY possible bebeift to patients, even if small....say 10%. If there was small benfit, and the drug safe, then we will approve and let the MARKET PLACE DECIDE on Erbitux success or failure. That is what critics have hammered the FDA on. If the drug is safe and show some kind of efficacy, approve it and let the market decide if they buy it. 25% threshold is OUT THE WINDOW. Fabulous news for SCLN. Now Zadaxin is a LOCK!, imo.

So, as of yesterday Zadaxin just got approved . Even in the trial that the shorts quote, 1994, Zadaxin got a documented 24% response rate. That is 240% BETTER than Erbitux at 10%. And they approved Erbitux!

Second, SCLN is in THREE cancer trials right NOW! Two phase 2`s in the U.S. and one phase 2 in Europe. In all three trials, earlier tests BLEW AWAY anything Erbitus showed the FDA in cancer response rates. And in Liver Cancer Zadaxin EXTENDED patient mortality by over SIX MONTHS. Erbitux showed NO EFFECT on patient mortality.

The Street and the fool analysts have yet to figure out what the FDA did yesterday. When they do, they will all "pundit-ize" at once, and all the lemmings will jump on board why it is such a good thing for the biotech inductry. Specifically for us SCLN! And now SCLN WILL NOT have to wait for U.S. Phase 3 to end. If the FDA is approving safe drugs with a 10% response rate....what will investors handicap the SCLN shance with our FDA, if the Japan Phase 3 naive patients got a 35%-40% SVR???? CURE RATE????. If we pull TRIPLE or QUADRUPLE of the "Erbitux Threshold" (10%)...then investors must start to handicap, or discount into (and upwards) the price of SCLN for very likely approval by FDA. At teh very worst? Theh now written in FDA stone "Erbitux Threshold" of 10%, will place a lid on how much DOWN SCLN can go. Small biotechs ALL got a lot more attractive yesterday...not just SCLN...ALL snmall biotechs..........Big pharma has far less risk in going with small pharma since the bar dropped from 25% to possibly 10%......the FDA just threw the "bar" on the floor!

That is how important this decision is. To SCLN and to all biotechs, large and small. You heard it here first.

See ya.

[muycaro]

Präsentation des CEO von Oncolytics genau heute in einer Woche in New York:

BIO CEO and Investor Conference 2004

Dr. Brad Thompson, Oncolytics President and CEO presenting Tuesday, February 24, 2004. New York, NY.

http://www.integratir.com/calendarcontent.asp?id=425&ticker=…

[muycaro]

Am 10.3. gibt ONCYs CEO



Dr. Brad Thompson
(Bild habe ich bei wallstreetreporter.com unter "leaders" gefunden - weiss nicht warum es dort eigentlich steht)

dann auch noch eine Präsentation auf einer Konferenz in Basel, Schweiz, zum besten:

3/10/2004 - BioSquare 2004
Dr. Brad Thompson, Oncolytics President and CEO presenting at BioSquare 2004 in Basel, Switzerland.

http://www.integratir.com/calendarcontent.asp?id=426&ticker=…

Ich hoffe dass es bis dahin etwas neues gibt, mit dem er die Zuhörerschaft (sollte es einen Live-Webcast geben, stelle ich den Link noch hier rein) ins Staunen versetzen kann.

[muycaro]

Hier nochmal ein interessanter Artikel über die finanzielle Entwicklung von Übernahmeangeboten im Biotech Sektor in den letzten Jahren (wir wollen nicht hoffen, dass es dazu kommt, allerdings ist die/das Tendenz/Fazit doch erfreulich):

http://www.signalsmag.com/signalsmag.nsf/0/C0D67BEC3F48A27F8…

[muycaro]

Sehe gerade dass der Ontario Teachers Pension Fund seine 150K Stücke, die sie sich letztes Jahr reingelegt haben, offensichtlich verkauft haben (Nasdaq.com).
Mellon Bank haben dafür 33K, Bankmont Financial 22.5K und MWN LTD 13K Stücke nachgelegt. Siehe:

http://www.nasdaq.com

Ich habe heute wieder so ein Gefühl, als ob ONCY in einer Trading Range zwischen $3,60 und $3,80 gehalten werden soll - siehe Intradaychart Nasdaq.

[muycaro]

Short History for ONC
Symbol Exch Report Date Volume Change

ONC T 2004-02-15 280,930 29,383
ONC T 2004-01-31 251,547 39,810
ONC T 2004-01-15 211,737 27,700
ONC T 2003-12-31 184,037 13,500
ONC T 2003-12-15 170,537 -70,980
ONC T 2003-11-30 241,517 -19,483
ONC T 2003-11-15 261,000 60,500
ONC T 2003-10-31 200,500 -391,401
ONC T 2003-10-15 591,901 -214,199
ONC T 2003-09-30 806,100 248,016
ONC T 2003-09-15 558,084 182,384
ONC T 2003-08-31 375,700 -305,400
ONC T 2003-08-15 681,100 400,900
ONC T 2003-07-31 280,200 13,406
ONC T 2003-07-15 266,794 7,194
ONC T 2003-06-30 259,600 94,503
ONC T 2003-06-15 165,097 99,631
ONC T 2003-05-31 65,466 -31,860
ONC T 2003-05-15 97,326 29,242
ONC T 2003-04-30 68,084 30,269
ONC T 2003-04-15 37,815 -47,385
ONC T 2003-03-31 85,200 25,000
ONC T 2003-03-15 60,200 -96,900
ONC T 2003-02-28 157,100 100,100
ONC T 2003-02-15 57,000 1,200
ONC T 2003-01-31 55,800 -4,500
ONC T 2003-01-15 60,300 22,400
ONC T 2002-12-31 37,900 5,000
ONC T 2002-12-15 32,900 10,974
ONC T 2002-11-30 21,926 7,526
ONC T 2002-11-15 14,400 8,156
ONC T 2002-10-31 6,244 -27,156
ONC T 2002-10-15 33,400 28,300
ONC T 2002-09-30 5,100 0
ONC T 2002-09-15 5,100 -13,200
ONC T 2002-08-31 18,300 4,700
ONC T 2002-08-15 13,600 300
ONC T 2002-07-31 13,300 13,300
ONC T 2002-06-30 0 -59,000
ONC T 2002-06-15 59,000 -69,700
ONC T 2002-05-31 128,700 -198,800
ONC T 2002-05-21 327,500 47,900
ONC T 2002-05-15 327,500 47,900
ONC T 2002-04-30 279,600 142,200
ONC T 2002-04-15 137,400 52,700
ONC T 2002-03-31 84,700 28,100
ONC T 2002-03-15 56,600 1,300
ONC T 2002-02-28 55,300 -19,200
ONC T 2002-02-15 74,500 -83,600
ONC T 2002-01-31 158,100 -252,179
ONC T 2002-01-15 410,279 405,179
ONC T 2001-12-31 5,100 -6,000
ONC T 2001-12-15 11,100 8,400
ONC T 2001-11-30 2,700 0
ONC T 2001-11-15 2,700 0
ONC T 2001-10-31 2,700 -8,500
ONC T 2001-10-15 11,200 -6,704
ONC T 2001-09-30 17,904 7,404
ONC T 2001-09-15 10,500 6,600
ONC T 2001-08-31 3,900 47
ONC T 2001-08-15 3,853 -1,147
ONC T 2001-07-31 5,000 -7,500
ONC T 2001-07-15 12,500 -1,300
ONC T 2001-06-30 13,800 -1,300
ONC T 2001-06-20 15,100 10,200
ONC T 2001-06-15 15,100 10,200
ONC T 2001-05-31 4,900 -3,600
ONC T 2001-05-15 8,500 -44,900
ONC V 2001-02-06 33,800 20,652
ONC V 2001-01-05 13,000 9,100
ONC V 2000-12-21 3,900 300
ONC V 2000-12-06 3,600 -1,100
ONC V 2000-11-21 4,700 -8,400
ONC V 2000-11-06 13,100 12,323
ONC V 2000-10-19 777 777
ONC V 2000-10-05 0 -544
ONC V 2000-09-07 3,238 1,438
ONC V 2000-08-21 1,800 0
ONC V 2000-08-04 1,800 0
ONC V 2000-07-20 1,800 0
ONC V 2000-07-07 1,800 -2,500
ONC V 2000-06-21 4,300 0
ONC V 2000-06-06 4,300 1,501
ONC V 2000-05-19 2,799 1,199
ONC V 2000-05-04 1,600 600
ONC V 2000-04-20 1,000 -1,244
ONC V 2000-04-07 2,244 2,044
ONC V 2000-03-21 200 0
ONC V 2000-03-06 200 -100
ONC V 2000-02-22 300 300
ONC V 2000-02-07 0 -940
ONC V 2000-01-20 940 940
ONC V 2000-01-07 0 -1,800
ONC V 1999-12-21 1,800 1,800

Die Liste zeigt, dass ich die Shortposition in T.ONC Aktien (in Kanada) in den letzten 14 Tagen um ca. 30K auf 280K Aktien erhöht hat.

[araucarius]

Neues vom Stockhouseboard von BIOEYE

(meiner Meinung nach einer der fachlich informiertesten des ganzen onc.to-Boards)

FWIW, I see astounding implications (fairly obvious to the astute reader) within current published patent applications that will, IMHO, change the course of cancer detection, diagnosis and treatment perhaps forever.

I suspect that BT is close to expanding on the matter. When he does, many parts of the puzzle will come together all at once.

I believe that once those implications are recognised for what they actually mean, you (along with the biotech industry and the practicing oncology community as a whole) will also be astounded.

BIOEYE

Q1@76

[muycaro]

Hallo araucarius!

Ich glaube dies ist das Patent (noch in der Zulassungsphase) auf das er sich bezieht:



United States Patent Application 20040029112
Kind Code A1
Thompson, Bradley G. ; et al. February 12, 2004

--------------------------------------------------------------------------------
Oncolytic viruses as phenotyping agents for neoplasms


Abstract
The present invention provides a method of diagnosing neoplasms having a particular phenotype by using oncolytic viruses that selectively replicate in neoplasms having the particular phenotype. For example, reovirus does not replicate in normal cells. However, reovirus selectively replicate in cells with an activated ras pathway, which leads to death of these cells. Therefore, a cell which becomes neoplastic due to, at least in part, elevated ras pathway activities can be diagnosed by its susceptibility to reovirus replication. This invention can further be applied, using other oncolytic viruses, to the diagnosis and/or treatment of other tumors, such as interferon-sensitive tumors, p53-deficient tumors and Rb-deficient tumors. Kits useful in the diagnosis or treatment disclosed herein are also provided.


--------------------------------------------------------------------------------
Inventors: Thompson, Bradley G.; (Calgary, CA) ; Coffey, Matthew C.; (Calgary, CA)
Correspondence Name and Address: BURNS DOANE SWECKER & MATHIS L L P
POST OFFICE BOX 1404
ALEXANDRIA
VA
22313-1404
US


Assignee Name and Adress: Oncolytics Biotech Inc.
Calgary
CA


Serial No.: 602024
Series Code: 10
Filed: June 24, 2003

U.S. Current Class: 435/5
U.S. Class at Publication: 435/5
Intern`l Class: C12Q 001/70



--------------------------------------------------------------------------------

Claims

--------------------------------------------------------------------------------


We claim:

1. A method of detecting ras-activated neoplastic cells in a biological sample, comprising contacting the sample with a reovirus and determining the ability of the reovirus to replicate in the sample, wherein the ability of the reovirus to replicate indicates the presence of ras-activated neoplastic cells in the sample.

2. The method of claim 1 wherein the biological sample is from a mammal.

3. The method of claim 2 wherein the mammal is human.

4. The method of claim 1 wherein the reovirus is a mammalian reovirus.

5. The method of claim 4 wherein the mammalian reovirus is a serotype 3 reovirus.

6. The method of claim 5 wherein the serotype 3 reovirus is a Dearing strain reovirus.

7. The method of claim 1 wherein the reovirus is an avian reovirus.

8. The method of claim 1 wherein the biological sample is from an animal bearing a neoplasm selected from the group consisting of lung cancer, prostate cancer, colorectal cancer, thyroid cancer, renal cancer, adrenal cancer, liver cancer, pancreatic cancer, breast cancer, hematopoietic cancer and central and peripheral nervous system cancer.

9. A method of diagnosing a ras-activated neoplasm in an animal, comprising: (a) providing a biological sample from the animal, wherein the sample comprises cells; (b) contacting the sample with a reovirus under conditions which allow the reovirus to replicate in ras-activated cells; (c) determining the ability of the reovirus to replicate in the sample; and (d) identifying the animal as having a ras-activated neoplasm if the reovirus can replicate in the sample.

10. The method of claim 9 wherein the animal is human.

11. The method of claim 9 wherein the reovirus is a mammalian reovirus.

12. The method of claim 11 wherein the mammalian reovirus is a serotype 3 reovirus.

13. The method of claim 12 wherein the serotype 3 reovirus is a Dearing strain reovirus.

14. The method of claim 9 wherein the virus is an avian reovirus.

15. The method of claim 9 wherein the biological sample is from a neoplasm selected from the group consisting of lung cancer, prostate cancer, colorectal cancer, thyroid cancer, renal cancer, adrenal cancer, liver cancer, pancreatic cancer, breast cancer, hematopoietic cancer and central and peripheral nervous system cancer.

16. A method of treating or ameliorating a ras-activated neoplasm in an animal, comprising: (a) identifying a ras-activated neoplasm in the animal by providing a group of cells from the animal, contacting the cells with a reovirus under conditions which allow the reovirus to replicate in ras-activated cells, and identifying the cells as comprising ras-activated neoplastic cells if the reovirus can replicate in the cells; and (b) administering to the animal an effective amount of a therapeutic agent that is selective for ras-activated neoplasms.

17. The method of claim 16 wherein the therapeutic agent is an oncolytic virus selected from the group consisting of reoviruses, adenoviruses mutated in the VA1 region, vaccinia viruses mutated in the K3L and/or E3L region, parapoxvirus orf viruses mutated in the OV20.0L gene, influenza viruses mutated in the NS-1 gene, and herpes viruses mutated in the .gamma..sub.134.5 gene.

18. The method of claim 16 wherein the animal is a mammal.

19. The method of claim 18 wherein the mammal is human.

20. The method of claim 16 wherein the reovirus is a mammalian reovirus or avian reovirus.

21. The method of claim 16 wherein the reovirus is a Dearing strain reovirus.

22. The method of claim 16 wherein the biological sample is from a neoplasm selected from the group consisting of lung cancer, prostate cancer, colorectal cancer, thyroid cancer, renal cancer, adrenal cancer, liver cancer, pancreatic cancer, breast cancer, hematopoietic cancer and central and peripheral nervous system cancer.

23. A method of diagnosing the presence of a neoplasm in a mammal, comprising contacting a sample of cells from said mammal with an oncolytic virus, wherein the ability of said virus to replicate in said sample indicates the presence of neoplasm in said mammal.

24. The method of claim 23 wherein the virus is selected from the group consisting of reoviruses, adenoviruses mutated in the VA1 region, vaccinia viruses mutated in the K3L and/or E3L region, parapoxvirus orf viruses mutated in the OV20.0L gene, influenza viruses mutated in the NS-1 gene, herpes viruses mutated in the .gamma..sub.134.5 gene, vesicular stomatitis virus, ONYX-015 virus, and Delta24 virus.

25. A method of detecting neoplastic cells having a particular phenotype in a biological sample, comprising contacting the sample with an oncolytic virus that selectively replicates in neoplastic cells having the particular phenotype, and determining the ability of the virus to replicate in the sample, wherein the ability of the virus to replicate indicates the presence of neoplastic cells having the particular phenotype in the sample.

26. The method of claim 25 wherein the particular phenotype is selected from the group consisting of interferon-resistance, p53-deficiency, Rb-deficiency, and PKR-deficiency.

27. The method of claim 25 wherein the virus is selected from the group consisting of: (a) vesicular stomatitis virus; (b) ONYX-015 virus; (c) Delta24 virus; and (d) a virus selected from the group consisting of adenoviruses mutated in the VA1 region, vaccinia viruses mutated in the K3L and/or E3L region, parapoxvirus orf viruses mutated in the OV20.0L gene, influenza viruses mutated in the NS-1 gene, and herpes viruses mutated in the .gamma..sub.134.5 gene.

28. A method of diagnosing a neoplasm having a particular phenotype in an animal, comprising: (a) providing a biological sample from the animal, wherein the sample comprises cells; (b) contacting the sample with an oncolytic virus that selectively replicates in neoplastic cells having the particular phenotype; (c) determining the ability of the virus to replicate in the sample; and (d) identifying the animal as having a neoplasm having the particular phenotype if the virus can replicate in the sample.

29. The method of claim 28 wherein the particular phenotype is selected from the group consisting of interferon-resistance, p53-deficiency, Rb-deficiency, and PKR-deficiency.

30. The method of claim 28 wherein the virus is selected from the group consisting of: (i) vesicular stomatitis virus; (ii) ONYX-015 virus; (iii) Delta24 virus; and (iv) a virus selected from the group consisting of adenoviruses mutated in the VA1 region, vaccinia viruses mutated in the K3L and/or E3L region, parapoxvirus orf viruses mutated in the OV20.0L gene, influenza viruses mutated in the NS-1 gene, and herpes viruses mutated in the .gamma..sub.134.5 gene.

31. A method of treating or ameliorating a neoplasm having a particular phenotype in an animal, comprising: (a) identifying a neoplasm having a particular phenotype in the animal by providing a group of cells from the animal, contacting the cells with an oncolytic virus that selectively replicates in neoplastic cells having the particular phenotype, and identifying the cells as comprising a neoplasm having the particular phenotype if the virus can replicate in the cells; (b) administering to the animal an effective amount of a therapeutic agent that is selective for neoplastic cells having the particular phenotype.

32. The method of claim 31 wherein the particular phenotype is selected from the group consisting of interferon-resistance, p53-deficiency, Rb-deficiency, and PKR-deficiency.

33. The method of claim 31 wherein the virus is selected from the group consisting of: (i) vesicular stomatitis virus; (ii) ONYX-015 virus; (iii) Delta24 virus; and (iv) a virus selected from the group consisting of adenoviruses mutated in the VA1 region, vaccinia viruses mutated in the K3L and/or E3L region, parapoxvirus orf viruses mutated in the OV20.0L gene, influenza viruses mutated in the NS-1 gene, and herpes viruses mutated in the .gamma..sub.134.5 gene.
--------------------------------------------------------------------------------

Description

--------------------------------------------------------------------------------


RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Applications Serial No. 60/392,031, filed Jun. 28, 2002; and Serial No. 60/443,188, filed Jan. 29, 2003. The entire disclosure of each of these prior applications is hereby incorporated by reference.

FIELD OF THE INVENTION

[0002] This invention relates to methods of detecting the underlying cause of tumors, particularly the use of reovirus in the diagnosis of ras-activated tumors. In addition, other oncolytic viruses with different selectivities can also be used in the diagnosis of particular tumor types.

REFERENCES

[0003] U.S. Pat. No. 6,136,307.

[0004] WO 94/18992, published Sep. 1, 1994.

[0005] Bischoff JR. et al., "An Adenovirus Mutant that Replicates Selectively in p53-Deficient Human Tumor", Science 274(5286):373-376 (1996).

[0006] Bos, J, "ras oncogenes in human cancer: a review", Cancer Res. 49:4682-4689 (1989).

[0007] Campbell, S. L. et al., "Increasing complexity of Ras signaling", Oncogene 17: 1395-1413 (1998).

[0008] Chandron and Nibert, "Protease cleavage of reovirus capsid protein mul and mulC is blocked by alkyl sulfate detergents, yielding a new type of infectious subvirion particle", J. of Virology 72(1):467-75 (1998).

[0009] Chang et al., J. Virol. 69:6605-6608 (1995).

[0010] Chang et al., Proc. Natl. Acad. Sci. 89:4825-4829 (1992).

[0011] Chang et al., Virol. 194:537-547 (1993).

[0012] Fueyo, J., et al., "A Mutant Oncolytic Adenovirus Targeting the Rb Pathway Produces Anti-Glioma Effect in Vivo", Oncogene 19(1):2-12 (2000).

[0013] Gutkind, J. S., "The pathways connecting G protein-coupled receptors to the nucleus through divergent mitogen-activated protein kinase cascades", J Biol Chem. 273:1839-1842 (1998).

[0014] Kawagishi-Kobayashi, M. et al., Mol. Cell. Biol. 17:4146-4158 (1997).

[0015] Nemunaitis, J., "Oncolytic viruses", J. Invest. New Drugs 17:375-386 (1999).

[0016] Nibert, M. L., Schiff, L. A., and Fields, B. N., "Reoviruses and their replication", pages 1557-96 in Virology (Fields et al., 3rd Edition), Lippencott-Raven Press, 1996.

[0017] Romano et al., Mol. Cell. Bio. 18(12):7304-7316 (1998).

[0018] Sharp et al., Virology 250:302-315 (1998).

[0019] Smith, R. E., et al., "Polypeptide components of virions, top component and cores of reovirus type 3", Virology, 39:791-800 (1969).

[0020] Smith, C. A. et al., "Correlations among p53, Her-2/neu, and ras overexpression and aneuploidy by multiparameter flow cytometry in human breast cancer: evidence for a common phenotypic evolutionary pattern in infiltrating ductal carcinomas", Clin Cancer Res. 6(1):112-26 (2000).

[0021] All of the publications, patents and patent applications cited above or elsewhere in this application are herein incorporated by reference in their entirety to the same extent as if the disclosure of each individual publication, patent application or patent was specifically and individually indicated to be incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

[0022] With recent developments in the field of oncology and cell biology, researchers have been able to begin drug development programs that specifically target the underlying cause of cancer, particularly if the cause is the deficiency or mutation of specific gene products. Therefore, if clinicians have the tools to determine the cause of cancer for each cancer patient, a treatment regime can be chosen which is tailored for the specific cause with optimized efficacy.

[0023] The ras oncogene accounts for a large number of tumors. Activating mutations of the ras gene itself occur in about 30% of all human tumors (Bos, J. L., 1989), primarily in pancreatic (90%), sporadic colorectal (50%) and lung (40%) carcinomas, as well as myeloid leukemia (30%). In addition to mutations of the ras gene itself, activation of the factors upstream or downstream of ras in the ras pathway is also associated with tumors. For example, overexpression of HER2/Neu/ErbB2 or the epidermal growth factor (EGF) receptor is common in breast cancer (25-30%), and overexpression of platelet-derived growth factor (PDGF) receptor or EGF receptor is prevalent in gliomas and glioblastomas (40-50%). EGF receptor and PDGF receptor are both known to activate ras upon binding to their respective ligand, and v-erbB encodes a constitutively activated receptor lacking the extracellular domain. Altogether, direct mutation of the ras oncogene or an upstream element in the ras pathway is believed to occur in approximately two thirds of all tumors.

[0024] Given the significant role of the ras pathway in tumorigenesis, it is desirable to be able to determine if a tumor is associated with activation of the ras pathway so that a specifically tailored treatment regime may be developed. Prior to the present invention, however, there has not been a simple and sensitive method of diagnosing the association of a cancer with the ras pathway. While mutations in the ras structural gene may be detected with a high sensitivity by polymerase chain reaction (PCR), there are many other factors in the ras pathway which may be the cause of high ras activity, such as mutations in the ras gene flanking sequences which lead to abnormally high expression level of the ras gene product, mutations in the structural genes of a factor upstream or downstream of ras in the ras pathway, or regulatory mutations which affect the expression levels of these upstream or downstream factors. Therefore, PCR for the ras gene does not precisely identify all cancers associated with activation of the ras pathway. The need remains for a simple and precise method of diagnosing ras-activated tumors.

SUMMARY OF THE INVENTION

[0025] The present invention provides a method of diagnosing neoplasms having particular phenotypes, particularly neoplasms mediated by abnormally high activity of the ras pathway, by using reovirus or other similar oncolytic viruses. Reovirus does not replicate in normal cells. However, reovirus selectively replicates in cells with an activated ras pathway, which leads to death of these cells. The ras pathway in these cells may be activated due to mutations of the ras structural gene or abnormalities of any other factor in the ras pathway which lead to activation of the pathway. Therefore, a cell which becomes neoplastic due to, at least in part, elevated ras pathway activities can be diagnosed by its susceptibility to reovirus replication.

[0026] Accordingly, one aspect of the present invention provides a method of detecting ras-activated neoplastic cells in a biological sample, comprising contacting the sample with a reovirus and determining the ability of the reovirus to replicate in the sample, wherein the ability of the reovirus to replicate indicates the presence of ras-activated neoplastic cells in the sample.

[0027] The biological sample is preferably from a mammal, particularly a human. Any reovirus capable of replicating in ras-activated cells may be used in the present invention, for example a mammalian reovirus or an avian reovirus. The mammalian reovirus is preferably a serotype 3 reovirus and more preferably a Dearing strain reovirus.

[0028] In a preferred embodiment, the biological sample is from an animal bearing a neoplasm selected from the group consisting of lung cancer, prostate cancer, colorectal cancer, thyroid cancer, renal cancer, adrenal cancer, liver cancer, pancreatic cancer, breast cancer, hematopoietic cancer and central and peripheral nervous system cancer.

[0029] Another aspect of the present invention provides a method of diagnosing a ras-activated neoplasm in an animal, comprising:

[0030] (a) removing a biological sample from the animal, wherein the sample comprises cells;

[0031] (b) contacting the sample with a reovirus under conditions which allow the reovirus to replicate in ras-activated cells;

[0032] (c) determining the ability of the reovirus to replicate in the sample; and

[0033] (d) identifying the animal as having a ras-activated neoplasm if the reovirus can replicate in the sample.

[0034] The animal is preferably a mammal, particularly a human. Any reovirus capable of replicating in ras-activated cells may be used in the present invention, for example a mammalian reovirus or an avian reovirus. The mammalian reovirus is preferably a serotype 3 reovirus and more preferably a Dearing strain reovirus.

[0035] In a preferred embodiment, the biological sample is from an animal bearing a neoplasm selected from the group consisting of lung cancer, prostate cancer, colorectal cancer, thyroid cancer, renal cancer, adrenal cancer, liver cancer, pancreatic cancer, breast cancer, hematopoietic cancer and central and peripheral nervous system cancer.

[0036] Another aspect of the present invention provides a method of treating or ameliorating a ras-activated neoplasm in an animal, comprising:

[0037] (a) identifying a ras-activated neoplasm in the animal by removing a group of cells from the animal, contacting the cells with a reovirus under conditions which allow the reovirus to replicate in ras-activated cells, and identifying the cells as comprising ras-activated neoplastic cells if the reovirus can replicate in the cells; and

[0038] (b) administering to the animal an effective amount of a therapeutic agent-that is selective for ras-activated neoplasms.

[0039] The therapeutic agent that is selective for ras-activated neoplasms is preferably an oncolytic virus. The oncolytic virus is preferably a reovirus, an adenovirus mutated in the VA1 region, a vaccinia virus mutated in the K3L and/or E3L region, a parapoxvirus orf virus mutated in the OV20.0L gene, an influenza virus mutated in the NS-1 gene, a herpes virus mutated in the .gamma..sub.134.5 gene, a vesicular stomatitis virus (VSV), or a Newcastle virus. Other therapeutic agents that are selective for ras-activated neoplasms include, without being limited to, farnesyl transferase inhibitors (FTIs) and RAF kinase inhibitors.

[0040] In any embodiment of the present invention, the reovirus may be a recombinant reovirus. The recombinant reovirus may be generated by co-infection of mammalian cells with different subtypes of reovirus. The recombinant reovirus may be naturally-occurring or non-naturally-occurring. The recombinant reovirus may be from two or more strains of reovirus, particularly two or more strains of reovirus selected from the group consisting of strain Dearing, strain Abney, strain Jones, and strain Lang. The recombinant reovirus may also result from reassortment of reoviruses from different serotypes, such as selected from the group consisting of serotype 1 reovirus, serotype 2 reovirus and serotype 3 reovirus. The recombinant reovirus may comprise naturally-occurring variant coat protein coding sequences or mutated coat protein coding sequences.

[0041] In addition to reovirus, a number of other oncolytic viruses are also selective for ras-activated neoplasms, and therefore they can be used to practice the present invention in the same manner as reovirus. These viruses include, without being limited to, adenoviruses mutated in the VA1 region, vaccinia viruses mutated in the K3L and/or E3L region, parapoxvirus orf viruses mutated in the OV20.0L gene, influenza viruses mutated in the NS-1 gene, or herpes viruses mutated in the .gamma..sub.134.5 gene. Thus, for example, one aspect of the present invention provides a method of detecting ras-activated neoplastic cells in a biological sample, comprising contacting the sample with an oncolytic virus that selectively replicates in PKR-deficient cells, and determining the ability of the virus to replicate in the sample, wherein the ability of the virus to replicate indicates the presence of ras-activated neoplastic cells in the sample. Preferably, the oncolytic virus is selected from the group consisting of adenoviruses mutated in the VA1 region, vaccinia viruses mutated in the K3L and/or E3L region, parapoxvirus orf viruses mutated in the OV20.0L gene, influenza viruses mutated in the NS-1 gene, and herpes viruses mutated in the .gamma..sub.134.5 gene.

[0042] Moreover, many other oncolytic viruses that are capable of selectively infecting particular tumor cells are also useful in the present invention in the same manner as reovirus. For example, vesicular stomatitis virus (VSV) can be used to diagnose interferon-resistant tumors, the ONYX-015 virus can be used to diagnose p53-deficient virus, and Delta24 virus can be used to diagnose Rb-deficient tumors. However, the oncolytic virus useful in the present invention is preferably not an adenovirus, particularly not the ONYX-015 virus.

[0043] Further provided by the present invention are methods of treating or ameliorating interferon-resistant tumors, p53-deficient tumors, or Rb-deficient tumors by first contacting a biological sample harvested from a tumor with a virus selected from the group consisting of VSV, ONYX-015 and Delta24, then treating the tumor with an appropriate therapeutic agent upon positive diagnosis.

[0044] Yet another aspect of the present invention provides a kit comprising a reovirus and a means for detecting replication of the reovirus. The detection means can be a pair of primers specific for the nucleic acid of the reovirus, and may optionally include reagents for PCR. The detection means can also be an antibody specific for a reovirus protein, as well as accompanying reagents such as secondary antibodies. The detection means can further be slides and dyes suitable for observing the morphology of infected cells under the microscope, or virus culture media and cells that can be used to determine the titer of the reovirus. Similarly, the present invention also provides kits comprising another virus capable of replicating in specific tumor cells, as well as means for detecting replication of the virus. Examples of these viruses include, without being limited to, VSV, ONYX-015 virus, and Delta24 virus.

[0045] Another aspect of this invention provides a kit comprising at least two viruses which can be used to phenotype tumors according to the present invention. The viruses are preferably selective for neoplasms with different phenotypes. Preferably, the viruses are selected from the group consisting of reovirus, VSV, the ONYX-015 virus, and the Delta24 virus.

[0046] Yet another aspect of this invention provides a kit comprising a virus useful for diagnosis of a neoplasm of a particular phenotype, as well as a therapeutic agent selective for the neoplasm.

[0047] Furthermore, since oncolytic viruses selectively replicate in neoplastic cells but not normal cells, another aspect of the present invention provides a method of diagnosing the presence of a neoplasm in a mammal, comprising contacting a sample of cells from said mammal with an oncolytic virus, wherein the ability of said virus to replicate in said sample indicates the presence of a neoplasm in said mammal.

[0048] Other aspects of the present invention would be evident in view of the entire disclosure of the present application.

DETAILED DESCRIPTION OF THE INVENTION

[0049] The present invention provides a method of diagnosing neoplasms having particular phenotypes by using oncolytic viruses. In particular, tumors mediated by abnormally high activity of the ras pathway can be diagnosed using reovirus. Reovirus does not replicate in normal cells. However, reovirus selectively replicates in cells with an activated ras pathway, which leads to death of these cells. Therefore, a ras-activated tumor can be diagnosed by its susceptibility to reovirus replication. The diagnosis will then facilitate the treatment or amelioration of the tumor with greater efficiency.

[0050] This invention can further be applied to diagnose and/or treat or ameliorate other tumors, such as interferon-resistant tumors, p53-deficient tumors and Rb-deficient tumors. Kits useful in the diagnosis or treatment disclosed herein are also provided.

[0051] Prior to describing the invention in further detail, the terms used in this application are defined as follows unless otherwise indicated.

[0052] Definitions

[0053] As used herein, "neoplastic cells", also known as "cells with a proliferative disorder", refer to cells which proliferate without the normal growth inhibition properties. A new growth comprising neoplastic cells is a "neoplasm" or "tumor". A neoplasm is an abnormal tissue growth, generally forming a distinct mass, that grows by cellular proliferation more rapidly than normal tissue growth. Neoplasms may show partial or total lack of structural organization and functional coordination with normal tissue. As used herein, a neoplasm is intended to encompass hematopoietic neoplasms as well as solid neoplasms.

[0054] A neoplasm may be benign (benign tumor) or malignant (malignant tumor or cancer). Malignant tumors can be broadly classified into three major types. Malignant neoplasms arising from epithelial structures are called carcinomas, malignant neoplasms that originate from connective tissues such as muscle, cartilage, fat or bone are called sarcomas and malignant tumors affecting hematopoietic structures (structures pertaining to the formation of blood cells) including components of the immune system, are called leukemias and lymphomas. Other neoplasms include, but are not limited to neurofibromatosis.

[0055] A "PKR deficient cell" is a cell in which PKR is not activated as in normal cells. Such PKR deficiency may be due to, for example, a mutation in the PKR gene or a reduced level of PKR protein or activity. For example, ras-activated neoplastic cells are PKR deficient because the activated ras pathway blocks phosphorylated of PKR. Assays for PKR protein or activity levels are known in the art.

[0056] As used herein, "ras-activated neoplastic cells" or "ras-mediated neoplastic cells" refer to cells which proliferate at an abnormally high rate due to, at least in part, activation of the ras pathway. The ras pathway may be activated by way of ras gene structural mutation, elevated level of ras gene expression, elevated stability of the ras gene message, or any mutation or other mechanism which leads to the activation of ras or a factor or factors downstream or upstream from ras in the ras pathway, thereby increasing the ras pathway activity. For example, activation of EGF receptor, PDGF receptor or Sos results in activation of the ras pathway. Ras-mediated neoplastic cells include, but are not limited to, ras-mediated cancer cells, which are cells proliferating in a malignant manner due to activation of the ras pathway.

[0057] A "ras-activated tumor" is a tumor in which the ras pathway is activated.

[0058] An "interferon-resistant tumor" or "a tumor having the phenotype of interferon-resistance" is a tumor that can not be treated or ameliorated with interferon-alpha, beta or gamma.

[0059] A "p53-deficient tumor" or "a tumor having the phenotype of p53-deficiency" is a tumor in which the level of the cellular tumor suppressor p53 is lower than that in a normal cell.

[0060] An "Rb-deficient tumor" or "a tumor having the phenotype of Rb-deficiency" is a tumor in which the level of the cellular tumor suppressor Rb is lower than that in a normal cell.

[0061] An "oncolytic virus" is a virus that selectively kills neoplastic cells. Killing of the neoplastic cells can be detected by any method established in the art, such as determining viable cell count, cytopathic effect, apoptosis of the neoplastic cells, synthesis of viral proteins in the neoplastic cells (e.g., by metabolic labeling, Western analysis of viral proteins, or reverse transcription polymerase chain reaction of viral genes necessary for replication), or reduction in size of a tumor.

[0062] As used herein, "reovirus" refers to any virus classified in the reovirus genus. The name reovirus (Respiratory and enteric orphan virus) is a descriptive acronym suggesting that these viruses, although not associated with any known disease state in humans, can be isolated from both the respiratory and enteric tracts. The term "reovirus" refers to all viruses classified in the reovirus genus.

[0063] The human reovirus consists of three serotypes: type 1 (strain Lang or T1L), type 2 (strain Jones, T2J) and type 3 (strain Dearing or strain Abney, T3D). The three serotypes are easily identifiable on the basis of neutralization and hemagglutinin-inhibition assays (See, for example, Nibert et al., 1996).

[0064] The reovirus may be naturally occurring or modified. The reovirus is "naturally-occurring" when it can be isolated from a source in nature and has not been intentionally modified by humans in the laboratory. For example, the reovirus can be from a "field source", that is, from a human who has been infected with the reovirus.

[0065] The reovirus may be modified but still capable of lytically infecting a mammalian cell having an active ras pathway. The reovirus may be chemically or biochemically pretreated (e.g., by treatment with a protease, such as chymotrypsin or trypsin) prior to administration to the proliferating cells. Pretreatment with a protease removes the outer coat or capsid of the virus and may increase the infectivity of the virus. The reovirus may be coated in a liposome or micelle (Chandron and Nibert, 1998) to reduce or prevent an immune response from a mammal which has developed immunity to the reovirus. For example, the virion may be treated with chymotrypsin in the presence of micelle forming concentrations of alkyl sulfate detergents to generate a new infectious subvirion particle.

[0066] The reovirus may be a recombinant reovirus resulting from the recombination/reassortment of genomic segments from two or more genetically distinct reoviruses. The recombinant reovirus may be from two or more types of reoviruses with differing pathogenic phenotypes such that it contains different antigenic determinants, thereby reducing or preventing an immune response by a mammal previously exposed to a reovirus subtype. Recombinant reoviruses may also exhibit different biological activities (e.g., replication activities in neoplastic cells and biodistribution) compared to the original reoviruses. Recombination/reassortment of reovirus genomic segments may occur in nature following infection of a host organism with at least two genetically distinct reoviruses. Recombinant virions can also be generated in cell culture, for example, by co-infection of permissive host cells with genetically distinct reoviruses (Nibert et al. 1996).

[0067] Accordingly, the invention contemplates the use of recombinant reoviruses resulting from reassortment of genome segments from two or more genetically distinct reoviruses, including but not limited to, human reovirus, such as type 1 (e.g., strain Lang), type 2 (e.g., strain Jones), and type 3 (e.g., strain Dearing or strain Abney), non-human mammalian reoviruses, or avian reovirus. The invention further contemplates the use of recombinant reoviruses resulting from reassortment of genome segments from two or more genetically distinct reoviruses wherein at least one parental virus is genetically engineered, comprises one or more chemically synthesized genomic segment, has been treated with chemical or physical mutagens, or is itself the result of a recombination event. The invention further contemplates the use of recombinant reovirus that has undergone recombination in the presence of chemical mutagens, including but not limited to dimethyl sulfate and ethidium bromide, or physical mutagens, including but not limited to ultraviolet light and other forms of radiation.

[0068] The invention further contemplates recombinant reoviruses that comprise deletions or duplications in one or more genome segments, that comprise additional genetic information as a result of recombination with a host cell genome, or that comprise synthetic genes.

[0069] "Phenotyping" a tumor means classifying a tumor according to its phenotype. For example, tumor phenotypes include ras pathway activation, interferon-resistance, p53-deficiency and Rb-deficiency. The phenotypes are not mutually exclusive, namely, a tumor may be phenotyped into more than one class.

[0070] A "biological sample" is a sample collected from a biological subject, such as an animal.

[0071] An "effective amount" is an amount which is sufficient to achieve the intended purposes. For example, an effective amount of reovirus for the purpose of treating or ameliorating a disease or medical condition is an amount sufficient to result in a reduction or complete removal of the symptoms of a disease or medical condition. The effective amount of a given therapeutic agent will vary with factors such as the nature of the agent, the route of administration, the size and species of the animal to receive the therapeutic agent, and the purpose of the administration. The effective amount in each individual case may be determined empirically by a skilled artisan according to established methods in the art.

[0072] "Treating or ameliorating" a disease or medical condition means the reduction or complete removal of the symptoms of a disease or medical condition.

[0073] A therapeutic agent is "selective" for a particular disease or medical condition if the agent is more effective for the disease or medical condition than for other diseases or medical conditions. Similarly, a therapeutic agent is selective for a particular group of neoplastic cells if the agent kills the particular group of neoplastic cells with higher efficiency than other neoplastic cells.

[0074] Method

[0075] The present invention is useful in the precise phenotyping of tumors, thereby facilitating the development of a treatment regime that is tailored for a specific tumor. In a preferred embodiment, reovirus is used to infect a biological sample harvested from a tumor-bearing animal. Since reoviruses selectively infect ras-activated neoplastic cells but not normal cells or tumor cells in which the ras pathway is not activated, the present method enables the practitioner to precisely determine if the tumor is associated with ras pathway activation. If diagnosed to be ras activated, the tumor can then be treated with ras-specific treatment regimens, such as reovirus therapy (U.S. Pat. No. 6,136,307).

[0076] The ras pathway is a complex signal transduction pathway that leads to cellular proliferation. Ras is a central relay in this pathway, receiving signals from upstream elements (e.g., growth factor receptors) and transmitting them to downstream elements.

[0077] Many growth factor receptors such as epidermal growth factor (EGF) receptor, platelet-derived growth factor (PDGF) receptor, as well as EGF receptor-related molecules (e.g. Her-2/Neu/ErbB2), possess an intrinsic tyrosine kinase activity which is activated by ligand-induced receptor dimerization. This results in autophosphorylation of the receptor on tyrosine residues and the binding of proteins containing Src-homology 2 (SH2) domains. Two such SH2 proteins are Grb2 and SHC which indirectly activate the plasma membrane-associated, small GTP-binding protein Ras. Ras activation also occurs in response to ligand binding to seven transmembrane domain G-protein coupled receptors (e.g. Gutkind, 1998). Activation of Ras and other growth factor receptor-regulated signaling pathways ultimately leads to changes in the cytoskeleton and gene expression which are necessary for cellular proliferation, differentiation, and transformation (reviewed in Campbell et al., 1998).

[0078] The three human ras genes (Ha-Ras, N-Ras, and Ki-Ras) encode 4 proteins (due to alternative splicing of the Ki-Ras mRNA). Under normal circumstances, Ras proteins cycle between an active (GTP-bound) state and an inactive (GDP-bound) state. Ras activation occurs by exchange of bound GDP for GTP, which is facilitated by a family of guanine nucleotide exchange factors. Ras inactivation occurs by hydrolysis of bound GTP to GDP. This reaction is facilitated by GTPase activating proteins (GAPs). In many human cancers, Ras proteins become oncogenically activated by mutations which destroy their GTPase activity, and thus deregulate Ras signaling (reviewed in Campbell et al., 1998).

[0079] Multiple candidate Ras effectors exist that may serve downstream of Ras in signal transduction and oncogenic transformation, including members of the Rho family of small GTPases, phosphatidylinositol-3 kinase (PI3K) and the serine/threonine protein kinase c-Raf-1 (reviewed in Campbell et al., 1998). Raf-mediated signaling is the best characterized Ras effector pathway. Activated Ras recruits Raf to the membrane where Raf activation occurs. Activated Raf is the initial component of a kinase cascade, the Mitogen-Activated Protein Kinase (MAPK) cascade. Raf phosphorylates and activates the MEK1 and MEK2 (MAPK/ERK kinase) protein kinases which, in turn, phosphorylate and activate the Extracellular signal Regulated Kinases ERK1 and ERK2 (also known as MAPK1 and MAPK2). Unlike their downstream targets, ERK1,2, the MEK1,2 proteins are highly specific enzymes whose only known substrates are the ERK1,2 proteins. Upon activation, ERK1 and ERK2 phosphorylate (and thus regulate) a variety of target proteins, including nuclear transcription factors, leading to the ultimate cellular response.

[0080] Accordingly, numerous events can lead to activation of the ras pathway. For example, a mutation may occur in any of the three ras structural genes. Structural mutations may also take place in the receptors upstream of ras, the signal transducers downstream from ras (such as raf or mek1,2), or the ultimate effectors MAPK1 and 2. Similarly, regulatory mutations that lead to abnormally high levels of expression of any protein in the ras pathway may also cause mitogenic cellular responses. Such regulatory mutations may occur anywhere in the regulatory sequences of a ras pathway member, or even in the structural or regulatory region of a factor that controls the expression of a ras pathway member. Consequently, detection of aberration of any specific member in the ras pathway is not an efficient way to determine if the ras pathway is activated.

[0081] It is possible to measure the activity of MAPK, the ultimate effector of the ras pathway, since constitutive activation of MAPK is indicative of ras pathway activation. However, such a biochemical approach requires a substantial amount of sample material, as well as tedious procedures such as extraction and/or partial purification of MAPK.

[0082] By detecting the ras activated phenotype rather than aberration of any specific gene or gene product, the present invention is useful whether the ras pathway activation is due to mutation of the ras structural gene, regulatory sequences of the ras gene, or any other factor in the ras pathway. Furthermore, the present method is relatively simple, without the need to extract or purify an enzyme from the sample.

[0083] The ability of reovirus to infect cells in a sample can be determined by any method in the art. For example, reovirus nucleic acid replication can be measured by polymerase chain reaction with primers specific for the reovirus used; reovirus protein synthesis can be detected by specific antibodies; infected cells can be observed under a microscope and evidence of cytopathic effects induced by the reovirus detected; and replicated reovirus can be harvested from the sample, and virus titer determined, to assess if viral replication has taken place. Other methods of determining the presence of reovirus replication are known to or may be developed by people of ordinary skill in the art.

[0084] It should be noted that a tumor may contain multiple oncogenic abnormalities. In particular, it has been reported that ras activation is often preceded by p53 over-expression in breast cancer (Smith et al., 2000). The presence of other oncogenic abnormalities in addition to ras pathway activation, however, does not impede the ability of a therapy regime specifically tailored for ras-activated tumors. For example, reovirus can still selectively kill ras-activated neoplastic cells even if the cells also contain abnormally high levels of p53.

[0085] Furthermore, since reovirus selectively replicates in ras-activated neoplastic cells but not normal cells, another aspect of the present invention provides a method of diagnosing the presence of a neoplasm in a mammal, comprising contacting a sample of cells from said mammal with a reovirus under conditions that allow the reovirus to replicate in ras-activated cells, wherein the ability of said reovirus to replicate in said sample indicates the presence of a neoplasm in said mammal.

[0086] Similar to reovirus, a number of other oncolytic viruses also selectively replicate in ras-activated cells. It is contemplated that these oncolytic viruses can be employed to practice the present invention in the same manner as reovirus. These viruses typically are mutants that are sensitive to the double stranded RNA kinase (PKR), whereas their wild type counterparts are not sensitive to PKR.

[0087] Normally, when a virus enters a cell, PKR is activated and blocks protein synthesis, and the virus can not replicate in this cell. Some viruses have developed a system to inhibit PKR and facilitate viral protein synthesis as well as viral replication. For example, adenovirus makes a large amount of a small RNA, VA1 RNA. VA1 RNA has extensive secondary structures and binds to PKR in competition with the double stranded RNA (dsRNA) which normally activates PKR. Since it requires a minimum length of dsRNA to activate PKR, VA1 RNA does not activate PKR. Instead, it sequesters PKR by virtue of its large amount. Consequently, protein synthesis is not blocked and adenovirus can replicate in the cell.

[0088] Ras-activated neoplastic cells are not subject to protein synthesis inhibition by PKR, because ras inactivates PKR. These cells are therefore susceptible to viral infection even if the virus does not have a PKR inhibitory system. Accordingly, if the PKR inhibitors in adenovirus is mutated so as not to block PKR function anymore, the resulting virus does not infect normal cells due to protein synthesis inhibition by PKR, but they replicate in ras-activated neoplastic cells which lack PKR activities.

[0089] Accordingly, a virus that is modified or mutated such that it does not inhibit PKR function selectively replicates in ras-activated neoplastic cells while normal cells are resistant. Preferably, the virus is an adenovirus mutated in the VA1 region, a vaccinia virus mutated in the K3L and/or E3L region, a parapoxvirus orf virus mutated in the OV20.0L gene, an influenza virus mutated in the NS-1 gene, or a herpes virus mutated in the .gamma..sub.134.5 gene.

[0090] The viruses can be modified or mutated according to the known structure-function relationship of the viral PKR inhibitors. For example, since the amino terminal region of E3 protein interacts with the carboxy-terminal region domain of PKR, deletion or point mutation of this domain prevents anti-PKR function (Chang et al., 1992, 1993, 1995; Sharp et al., 1998; Romano et al., 1998). The K3L gene of vaccinia virus encodes pK3, a pseudosubstrate of PKR. There is a loss-of-function mutation within K3L. Truncations or point mutations within the C-terminal portion of K3L protein that is homologous to residues 79 to 83 in eIF-2 abolish PKR inhibitory activity (Kawagishi-Kobayashi et al., 1997).

[0091] In another embodiment of the present invention, the vesicular stomatitis virus (VSV) can be used to diagnose interferon-resistant tumors. Interferons are circulating factors which bind to cell surface receptors and ultimately lead to both an antiviral response and an induction of growth inhibitory and/or apoptotic signals in the target cells. Although interferons can theoretically be used to inhibit proliferation of tumor cells, this attempt has not been very successful because of tumor-specific mutations of members of the interferon pathway.

[0092] However, by disrupting the interferon pathway to avoid growth inhibition exerted by interferon, tumor cells may simultaneously compromise their anti-viral response. Indeed, it has been shown that VSV, an enveloped, negative-sense RNA virus, rapidly replicated in and killed a variety of human tumor cell lines in the presence of interferon, while normal human primary cell cultures were apparently protected by interferon. VSV can thus be used to diagnose interferon-resistant yet VSV-sensitive tumors. Like the reovirus embodiment, VSV-based diagnosis is an assessment of the phenotype and does not depend on the mechanism of interferon resistance.

[0093] In another embodiment of the present invention, the ONYX-015 virus can be used to diagnose p53-deficient tumors. p53 is a potent tumor suppressor, which is present in every cell and controls cell growth. Since viruses rely on the cellular proliferation machinery to replicate, they are subject to p53 regulation and can not over-replicate. Certain adenovirus, SV40 and human papilloma virus, however, include proteins which inactivate p53, thereby allowing their own replication (Nemunaitis 1999).

[0094] For adenovirus serotype 5 this protein is a 55 Kd protein encoded by the E1B region. If the E1B region encoding this 55 kd protein is deleted, as in the ONYX-015 virus (Bischoff et al, 1996; WO 94/18992), the 55 kd p53 inhibitor is no longer present. As a result, when ONYX-015 enters a normal cell, p53 functions to suppress cell proliferation as well as viral replication. Therefore, ONYX-015 does not replicate in normal cells. On the other hand, in neoplastic cells with disrupted p53 function, ONYX-015 can replicate and eventually cause the cell to die. Accordingly, this virus can be used to detect p53-deficient neoplastic cells in a sample. A person of ordinary skill in the art can also mutate and disrupt the p53 inhibitor gene in adenovirus 5 or other viruses using established techniques, and the resulting viruses are useful in the present method to diagnose p53-deficient tumors.

[0095] Similarly, the Delta24 virus can be used to diagnose Rb-deficient tumors. The Delta24 virus is a mutant adenovirus carrying a 24 base pair deletion in the E1A region (Fueyo et al., 2000). This region is responsible for binding to the cellular tumor suppressor Rb and inhibiting Rb function, thereby allowing the cellular proliferative machinery, and hence virus replication, to proceed in an uncontrolled fashion. Delta24 has a deletion in the Rb binding region and does not bind to Rb. Therefore, replication of the mutant virus is inhibited by Rb in a normal cell. However, if Rb is inactivated and the cell becomes neoplastic, Delta24 is no longer inhibited. Instead, the mutant virus replicates efficiently and lyses the Rb-deficient cell. Accordingly, the Delta24 virus can be used to determine if a sample contains Rb-deficient tumor cells.

[0096] As is the case with the ras-activated tumor cells, p53-deficient or Rb-deficient cells may be the result of a variety of reasons. For example, a mutation in the structural gene of p53 or Rb may lead to a malfunctioning gene product or poor translation, a mutation in the regulatory sequence of the p53 or Rb gene may cause reduced amount of transcription, a mutation in a transcription factor for the p53 or Rb gene may result in deficient p53 or Rb production, or a mutation in a co-factor necessary for p53 or Rb function may also be the reason of p53- or Rb-deficiency. Since the present invention detects the phenotype, rather than structural aberration of the p53 or Rb gene/protein only, it is more powerful than structure-based methods, such as PCR.

[0097] Once the phenotype of a tumor has been determined, the tumor can be treated according to its phenotype. For example, a ras-activated tumor can be treated by reovirus, or inhibitors of the ras pathway. Accordingly, the present invention also provides a method of treating or ameliorating a ras-activated neoplasm in an animal, comprising identifying a ras-activated neoplasm in the animal by removing a group of cells from the animal, contacting the cells with a reovirus under conditions which allow the reovirus to replicate in ras-activated cells, identifying the cells as comprising ras-activated neoplastic cells if the reovirus can replicate in the cells, and administering an effective amount of reovirus to the mammal. Reovirus therapy has been disclosed, for example, in U.S. Pat. No. 6,136,307.

[0098] Furthermore, the present invention also provides methods of treating or ameliorating a tumor, comprising collecting a sample, identifying the phenotype of the sample with VSV, the Delta24 or ONYX-015 virus, and administering an effective amount of a suitable therapeutic agent according to the phenotype. The therapeutic agent may be the virus itself, or, in the case of p53 or Rb-deficiency, activators of p53 or Rb functions. It should be noted that Delta24 and ONYX-015 are merely examples to elucidate the application of the present invention, while a person with ordinary skill in the art will be able to identify or develop other viruses useful in the diagnosis and treatment of tumors according to the present disclosure.

[0099] As with reovirus, the use of immunoprotected or reassortant viruses of other oncolytic viruses are also encompassed in the present invention. Furthermore, in addition to the viruses specifically discussed in the present application, a person of ordinary skill in the art can practice the present invention using additional oncolytic viruses according to the disclosure herein and knowledge available in the art. The oncolytic virus may be a member in the family of myoviridae, siphoviridae, podoviridae, teciviridae, corticoviridae, plasmaviridae, lipothrixviridae, fuselloviridae, poxviridae, iridoviridae, phycodnaviridae, baculoviridae, herpesviridae, adenoviridae, papovaviridae, polydnaviridae, inoviridae, microviridae, geminiviridae, circoviridae, parvoviridae, hepadnaviridae, retroviridae, cyctoviridae, reoviridae, birnaviridae, paramyxoviridae, rhabdoviridae, filoviridae, orthomyxoviridae, bunyaviridae, arenaviridae, leviviridae, picornaviridae, sequiviridae, comoviridae, potyviridae, caliciviridae, astroviridae, nodaviridae, tetraviridae, tombusviridae, coronaviridae, glaviviridae, togaviridae, or barnaviridae.

[0100] The present invention can be applied to any animal, particularly mammals. Preferred mammals include dogs, cats, sheep, goats, cattle, horses, pigs, humans and non-human primates. Most preferably, the mammal is human.

[0101] Kits

[0102] The present invention provides kits useful for the diagnosis and/or treatment of tumors. One aspect of the present invention provides a kit comprising a reovirus and a means for detecting replication of the reovirus. The detection means can be a pair of primers specific for the nucleic acid of the reovirus, and may optionally include reagents for PCR. The detection means can also be an antibody specific for a reovirus protein, and may optionally contain the accompanying reagents such as secondary antibodies. The detection means can further be slides and dyes suitable for observing the morphology of infected cells under the microscope, or virus culture media and cells that can be used to determine the titer of the reovirus. Similarly, the present invention also provides kits comprising another virus capable of replicating in specific tumor cells, as well as means for detecting replication of the virus. Examples of these viruses include, without being limited to, VSV, the ONYX-015, and Delta24 virus.

[0103] Another aspect of this invention provides a kit comprising at least two viruses which can be used to phenotype tumors according to the present invention. Preferably, the viruses are selected from the group consisting of reovirus, VSV, the ONYX-015 virus, and the Delta24 virus.

[0104] The following examples are offered to illustrate this invention and are not to be construed in any way as limiting the scope of the present invention.

EXAMPLES

[0105] In the examples below, the following abbreviations have the following meanings. Abbreviations not defined have their generally accepted meanings.

1 .degree. C. = degree Celsius hr = hour min = minute .mu.M = micromolar mM = millimolar M = molar ml = milliliter .mu.l = microliter mg = milligram .mu.g = microgram PAGE = polyacrylamide gel electrophoresis rpm = revolutions per minute FBS = fetal bovine serum DTT = dithiothrietol SDS = sodium dodecyl sulfate PBS = phosphate buffered saline DMEM = Dulbecco`s modified Eagle`s medium .alpha.-MEM = .alpha.-modified Eagle`s medium .beta.-ME = .beta.-mercaptoethanol MOI = multiplicity of infection PFU = plaque forming units EGF = epidermal growth factor PDGF = platelet derived growth factor CPE = cytopathic effect VSV = vesicular stomatitis virus PCR = polymerase chain reaction SH2 = src-homology 2

Example 1

Phenotyping a Tumor With Reovirus

[0106] A lump is found in a 65 year old woman when she has her regular mammogram. A sample is collected from the lump during biopsy and appears to be a malignant tumor. In order to determine if the tumor contains ras-activated cells, the sample is placed in cell culture and incubated with reovirus.

[0107] The Dearing strain of reovirus serotype 3 is propagated in suspension cultures of L-929 cells purified according to Smith (Smith et al., 1969) with the exception that .beta.-mercaptoethanol (.beta.-ME) is omitted from the extraction buffer. The particle/PFU ratio for purified reovirus is typically 100/1. The biopsy sample is minced in DMEM, incubated with reovirus for 2 hours at 37.degree. C., changed to fresh DMEM plus 20% FBS, and cultured for 48 hours. Thereafter, the supernatant of the culture is collected and reovirus titer is determined. The result indicates that reovirus has replicated in the sample. Therefore, the breast tumor contains ras-activated tumor cells.


* * * * *


____________________________________________________

Ich denke hier läuft einiges mehr hinter den Kulissen ab als sich "Otto-Normal-Shareholder" so vorstellt.

Ich hatte heute Kontakt mit Cathy Ward von den IR.
Sie teilte mir mit, dass ONCY auf der Konferenz nächsten Dienstag nur eine "Poster Presentation" abhalten würden, was soviel heisst wie, dass sie sich einen kleinen Stand mit einer Grafik aufbauen würden und das Fachpublikum Brad Fragen stellen kann. Es ist nicht geplant, dass Brad selbst vor einem grösserem Publikum sprechen wird.

Auf der nächsten Konferenz in der Schweiz wird Brad dann eine Präsentation vor Publikum halten, allerdings wird diese nicht durch einen webcast übertragen, so Cathy.

[schachi]

muycaro was geht?

jetzt gibt es wirklichen Neuigkeiten bezüglich ONCY und wir hören nichts von Dir.... (ist nur nett gemeint).

Also auf gehts

http://biz.yahoo.com/prnews/040227/to253_1.html

http://biz.yahoo.com/prnews/040227/to257_1.html

somit wird mein Aktiendepot hoffentlich neue Höhen erreichen und ich glaube deins auch...

[muycaro]

WOW, das ist ja der Hammer!!!

Da hören wir monatelang nichts von der Company und dann gleich 2 News Releases auf einmal (Montag/Dienstag wäre mir allerdings lieber gewesen, Freitag ist immer net so dolle - allerdings hat die FDA gestern Genentechs (DNA) Avastin zugelassen, von daher sollte heute der Fokus eh auf die Biotechs gerichtet sein, ausserdem sind die Futures ordentlich im Plus.):

1. Endlich sind die Ergebnisse der Prostate Trials auf dem Tisch (wie zu erwarten keine Sicherheitsbedenken).

2. Und basierend auf 1 die Genehmigung die Systemic trials (intravenöse Verabreichung von Reolysin!!! das ist die Killerapplication für Reolysin!!!) in England zu starten (und ich denke dann kann es auch nich mehr lange dauern bis die ersten Trials in den USA anfangen).

Jetzt demnächst bitte noch die Ergebnisse der Glio Trials und der Start der NCI Trials, anderer Trials ausserhalb Kanadas, und wenn möglich noch einige neue Patente...

Das muss ich erstmal sacken lassen. Melde mich später nochmal (ich frage mich gerade welche Idioten, entschuldigt die Ausdrucksweise gerade noch in Deutschland UNTER Wert - wahrscheinlich sogar an den MM -verkauft haben - oh Mann!)!!

Sorry, der Beitrag ist etwas konfus, aber ich muss mich erstmal sammeln!

Viel Glück Euch allen!

P.S. Yippie!

P.P.S.: Hallo schachi. Ich denke unsere Portfolios werden sich heute zumindest nicht negativ entwickeln...

[muycaro]

Vorbörslich stehen schon 4,18 USD im Bid.

[muycaro]

4,60 USD werden geboten, erste Briefseite 4,75 USD, wurde gerade bezahlt!!!

[muycaro]

Viele Grüsse von hier "oben" an alle die heute morgen unter 3 Euro verkauft haben...

[muycaro]

Kopiert aus dem ONCY Board bei Yahoo (Beitrag ist von einem Poster, der in dem Sektor tätig ist und über SEHR viel Kompetenz in dem Bereich verfügt - kann immer nur wieder staunen und mich freuen, dass wir solche Leute mit "an Bord" haben):



On UK approval
by: matdu1 02/27/04 07:57 am
Msg: 9888 of 9893

It`s exciting to see 2 NRs this morning. I will share some thoughts on the UK trial here and that on the prostate results in a later post. As I posted in an earlier message dated Feb 10, UK is an obvious choice for initiating clinical trials in Europe (see post).

Re: european clinical trials
by: matdu1
02/10/04 01:33 pm
Msg: 9445 of 9880
To gain eventual approval in the EU, I suspect that ONC would be seeking to initiate clinical trials in Europe. Britain is an obvious choice since it`s known to be a relatievly friendly country for doing clinical trials. Would not be surprised to see a CTX (clinical trial exemption) or a CTC (clinical trial certificate) coming from the British Medicines and Healthcare products Regulatory Agency
(MHRA) if that`s the case.

"a Phase I clinical trial to investigate the systemic delivery of REOLYSIN(R) as a
treatment for patients with advanced or metastatic solid tumours"

It`ll be a phase I study on a # of cancers. This sets the table for the selection of the kinds of cancers in the future, more advanced phases of trials. Look for possible multiple indication trials done in parallel after the phase I is completed. Also this UK approval is not replacing the US FDA systemic IND, I expect future approval from the FDA likely as a phase I/II trial.

"The approval of this trial is the culmination of an extensive program in the areas of manufacturing and preclinical toxicology."

I would add that results from the prostate trial and the glioma trial also provide the the necessary information for the regulatory agencies to approve the systemic trial. Safety is always the #1 issue in the mind of the reviewers, and data from the prostate and glioma trials are confimatory of the safety profile of Reolysin.

"The primary objective of the study is to determine the maximum tolerated dose
(MTD), dose limiting toxicity (DLT) and safety profile of REOLYSIN(R).
Secondary objectives include the evaluation of viral replication, immune
response to the virus and any evidence of antitumour activity. The enrolment
in this study is expected to be up to forty evaluable patients"

Unlike most other trials, cancer trials allow applicants to recruite cancer patients (instead of normal volunteers), thus one can observe both safety and dosing profiles of the drug (primary objective in this study), as well as some degree of efficacy (secondary endpoint). Viral replication, immune response and antitumor activity (secondary endpoints) are all the same parameters examined in the prostate trial. In many ways, the prostate trial is the "warm-up" study for the systemic trials in terms of determining what parameters are meaningful and measurable. There perhaps is a good reason for releasing the prostate results simultaneously with the announcement of this UK approval.

Forty patients are expected to be enrolled. This is a high # for a phase I. However, as I stated earlier, this phase I is a set-up for the multiple indication trials later. There will be patients with various types of cancer enrolled. For each cancer type, they may end up with 8-10 patients (just a guess on my part here).

[muycaro]

ONCY ist "inplay":

7:34AM Oncolytics Biotech receives approval to initiate UK Phase I Cancer Trial investigating systemic delivery of REOLYSIN (ONCY) 3.68: Co provided a final update on its technical clinical study evaluating the efficacy and safety of REOLYSIN for the treatment of T2 prostate cancer; says clinical trial has met its histopathological objective of showing that REOLYSIN selectively infects and kills tumour cells in humans without damaging adjacent healthy tissue. Separately, co announces it has received approval to initiate UK Phase I Cancer Trial investigating systemic delivery of REOLYSIN.



http://finance.yahoo.com/mp#oncy

Ich denke das wird ein ziemlich wilder Ritt heute.

Meine These: wahrscheinlich zu Beginn erstmal dramatisches Gap Up, dann leicht nachgebende Notierungen, wenn die Trader wieder rauswollen. Dann bis zum Schluss langsam anziehender Kurs, kommt eben ganz drauf an, welche Adressen heute auf ONCY aufmerksam werden.

[muycaro]

Hier nochmal ein Kommentar von matdu1 vom ONCY Board bei Yahoo bezüglich des Beendigung der Prostata Krebs Studien:

On Prostate Update
by: matdu1 02/27/04 09:04 am
Msg: 9895 of 9896

The prostate trial was performed primarily to provide safety data on Reolysin. The key finding in the study is that reovirus appears to infect selectively only cancer cells and not normal cells:

"This clinical trial has met its histopathological objective of showing that REOLYSIN(R) selectively infects and kills tumour cells in humans without damaging adjacent healthy tissue,"

The trial was done to satisfy regulatory agencies` demand for appoving the systemic trials:

"The data generated was helpful in gaining approval to commence systemic administration studies."

As a replicating virus, the regulatory agencies would like to make sure that Reolysin would not multiply and spread out of control when introduced in humans. I believe they agreed on doing this T-2 prostate trials because this is an early stage cancer and that the patients were to receive surgery soon after the Reolysin treatment, thus minimizing any potential harms to the patients in case something negative should emerge. The drawback of the T2 trial is that they could not possibly obtain any survival benefit data from the trial. Anyhow, the prostate trial served its functions and will not be continued beyond the phase II stage.

"Additional histopathological analysis has demonstrated immune cell infiltration (B and T cells) into virus infected tumour mass. This infiltration was not noted in adjacent normal tissue. Further histopathological analysis including microarray (a measure of gene expression) is currently being conducted."

As I had written some months ago, the prostate trial allowed researchers to look at the safety profile at the physical and physiological (side effects, adverse events, toxicities etc) levels; and to determine the pharmacokinetics (PK) and pharmacodynamics (PD) at the cellular and molecular levels. PK tells us what the body does to the drug (immune cell infiltration, excretion of virus, viral load in the blood,etc); while PD informs us on what the drug does to the body (killing cancer cells, viral spreading, effect on normal cells, etc).

Results from this study indicate that Reolysin is safe, able to infect cancer cells withoug spilling over to impact normal cells. As stated "imuune cell infiltration into virus infected tumor mass...was not noted in adjacent normal tissue". This observation provides strong evidence on the specificity in the infecting profile of Reolysin.
There is also mention of using microarray to determine if there are genes that may be up- or down-regulated during the treatment. Microarray provides a quick and dirty way to identify possible genes involvement and may lead to identificatin of novel gene products of interest. At this point, it sounds more like a research project that may or may not yield concrete results.

For those who are skeptical until the prostate results are published in some peer-reviewed journal, they should remember that when filing INDs that include the prostate results, the review team has the chance to see all the data (possibly more than what a journal reviewer would see) before their decisions. Some of the scientists at CBER whom I know and had worked with side by side are top notch, no non-sense individuals.

[muycaro]

Und hier nochmal "fürs Archiv" was rjc dazu zu sagen hat (hat m.E. nicht die fachliche Kompetenz wie matdu, ist oft zu euphorisch, allerdings sehr genau mit der Story von ONCY vertraut und hat wohl auch relativ gute Beziehungen zum Management):


Re: On Prostate Update
by: rjc2827 02/27/04 09:32 am
Msg: 9902 of 9905

What the prostate results mean.

When the original Phase I (safety Trial) patients received the injections of REOLYSIN into their tumors just beneath the skin, a lot of them saw their tumors shrink. Some saw remote tumors on other parts of their body shrink as well. But maybe it was all a coincidence in timing, or perhaps divine intervention, or … maybe it was the action of the REOLYSIN that effected the benefit.

In the special case of brain cancer, patients received their injections of REOLYSIN directly into the tumor in their brain, and many of them lived (or are still living), dramatically longer than was expected if the REOLYSIN weren’t injected. But maybe it was something that they ate, or perhaps extra exercise, or … maybe it was the action of the REOLYSIN, that effected the benefit.

We had the dead cancer cells, but we didn’t have the smoking hypodermic.

Well now we do!

What the results of the technical Phase II direct injection prostate Trial show, through the histopathalogical examinations of the prostate tumors, is that REOLYSIN selectively infects and kills tumor cells in humans, and HOW it does it, both precisely as predicted by Oncolytics. The results seen in the earlier Trials can now be attributed to REOLYSIN with certainty. In fact, we now have documentation indicating that REOLYSIN could be considered as a FIRST LINE THERAPY for cancer once we get approval … that is, the therapy that is generally used first, with other therapies tried later, and then, only if REOLYSIN isn’t effective against a given cancer cell line.

What must be noted is that Oncolytics is progressing through clinical trials EXACTLY as they had planned, and in the correct order. The Phase II prostate Trial was a technical study that provided required information for the FDA and demonstrated the “general” application (not just prostate), which will allow REOLYSIN to be considered as a first line therapeutic. Advanced prostate cancer will be considered for one of the future systemic Trials.

What remains to be done is to proceed through the required studies to gain approval from the FDA for REOLYSIN’s use as a therapeutic, and to determine the most effective method of delivery for REOLYSIN. It is currently expected that a systemic delivery will be the best route for all cancers, other than the special case of brain cancer, and that multiple injections or infusion, rather than the single injection protocol used in the Phase I glio Trial, will be the preferred method of delivery for brain cancer.

So what do the prostate results mean? They mean that REOLYSIN works, and that now we’ve got the proof!

This post contains forward looking statements, within all the possible meanings of forward looking.

rjc

[MONSIEURCB]

..puhhh...Balsam für Nerven & Seele...ich schätze mal, dass unsere ONCY künftig generell mehr in den Blickpunkt gerät - und das kann dem Kurs nur gut tun, solange nicht die Shortis ihr Spielchen anfangen....happy weekend" - "Monse" Chris

[muycaro]

Reuters
Oncolytics Phase I cancer test meets objectives
Friday February 27, 9:22 am ET


TORONTO, Feb 27 (Reuters) - Oncolytics Biotech Inc. (Toronto:ONC.TO - News; NasdaqSC:ONCY - News) said on Friday its Phase I clinical trial to evaluate the safety of Reolysin to treat prostate cancer met objectives.
The study showed that "Reolysin selectively infects and kills tumor cells in humans without damaging adjacent healthy tissue," said Dr. Brad Thompson, president and chief executive.

The study involved six patients who received a single injection of Reolysin and were monitored for about three weeks.

Shares of Calgary, Alberta-based Oncolytics closed at C$4.90 in Toronto on Thursday. They ended at $3.68 on the Nasdaq.

($1=$1.35 Canadian)


http://biz.yahoo.com/rc/040227/health_oncolytics_1.html

Wow, in den ersten 30 Minuten schon über 700.000 Aktien gehandelt (Nasdaq + Toronto) - denke das werden noch "einige" mehr heute.

Vielleicht war das ja doch ganz gut die News am Freitag zu releasen (obwohl Oncolytics Management ja immer wieder sagt: "we don`t time news releases"), denn ich denke über das Wochenende wird das noch in einigen Printmedien erscheinen.

Demnächst kommen auch die wichtigen Konferenzen der AACR und ASCO (März und Juni). Ich denke da sollten dann weitere Details zu den Prostatastudien bekannt werden.

Nach dem anfänglichen "Hype" in der Vorbörse sind wir wie vermutet etwas zurückgekommen, um uns danach wieder langsam Richtung Norden zu machen. Mir reicht das Halten der 4 USD Marke fürs erste. Lieber langsam und beständig als immer so explosiv... LOL

[muycaro]

Monse, die Leerverkäufer der 100K Aktien seit Anfang des Jahres:

Short History for ONC
Symbol Exch Report Date Volume Change

ONC T 2004-02-15 280,930 29,383
ONC T 2004-01-31 251,547 39,810
ONC T 2004-01-15 211,737 27,700
ONC T 2003-12-31 184,037 13,500

sollten gerade ziemlich "unter Wasser" sein.

[muycaro]

Jetzt über 1 Mio. Aktien gehandelt!
Das sind immerhin ca. 4% aller ausstehenden (z.Zt. ca 27M. 29-30M, sollten alle Optionen und Warrants ausgeübt werden).

[merx]

Sat, February 28, 2004
Calgary biotech soaring


By JON HARDING, BUSINESS EDITOR


The stock of a Calgary biotech firm skyrocketed yesterday after the company received approval from British medical authorities to start a new, early phase of testing of its patented cancer drug. Shares of Oncolytics Biotech Inc. soared 70 cents -- almost 15% -- to $5.60 with a high volume traded on the Toronto stock market.

Britain`s medicines and healthcare products regulatory agency approved a trial to administer the cancer drug Reolysin intravenously, the company said

The drug, discovered in 1999 through research at the University of Calgary, is used to fight advanced, metastatic tumours.

"It`s a very exciting, important day for us," said company president and CEO Dr. Brad Thompson.

Oncolytics Biotech Inc. also announced a final update to its clinical study of Reolysin, which showed the virus-based treatment is non-toxic and selectively infects and kills tumour cells in humans without damaging adjacent healthy tissue. Patients with prostate cancer took part in that study.

"The prostate study got us to an end point and provided the data about (Reolysin`s) safety. In my opinion, the reason there is so much interest today (on the stock markets) is because we`ve been approved in the U.K. for the new study," Thompson said of research to be carried out at London`s Royal Marsden Hospital, Britain`s leading centre for cancer treatment.

Thompson said approval to do intravenous, or systemic, testing is important because about 90% of cancers can be treated that way. Testing will be carried out in London of a much larger pool of patients at the Royal Marsden Hospital, the company said.

One Calgary stock watcher warned investors it`s far too early to bank on Reolysin.

Mike Quinn, senior vice-president of Bissett Investment Management, was surprised, given the risk of biotech stocks, to see Oncolytics` market value shoot up by about $20 million in one day.

"It`s a biotech stock and has risk in the nth-degree. All the report says is that it`s not toxic," said Quinn.

"I`m not sure it`s even on the Monopoly board at this stage, let alone rounding the corner for home. Drug sales could still be seven, eight, nine years down the road."



Next story: Economy boasts uplifting ending

[merx]

Select a city --------- Victoria Vancouver Calgary Edmonton Regina Saskatoon Winnipeg Hamilton Toronto Ottawa Montreal Maritimes --------- more cities... --BC Dawson Creek Fort St. John Kamloops Kelowna Nanaimo Prince George Prince Rupert Trail --AB Lethbridge Red Deer --ON Windsor












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STORY
Calgary cancer drug approved for testing
Firm stresses treatment is years away

Robin Summerfield
Calgary Herald


Saturday, February 28, 2004

Dr. Brad Thompson, president and CEO of Oncolytics Biotech Inc.: "It`s a big day for us."

CREDIT: Ted Rhodes, Calgary Herald

ADVERTISEMENT



The British government has given a Calgary biotech company approval to start testing its promising cancer treatment drug on 40 patients in the United Kingdom.

The approval for a clinical trial at the Royal Marsden Hospital in Surrey came this week and is another step forward for Calgary-based Oncolytics Biotech Inc., and its drug Reolysin, company officials said Friday.

"It`s a big day for us," said company president and CEO Dr. Brad Thompson.

He was quick to caution the drug will not be available any time soon on the market for treatment of cancer patients.

"It`s a very long and complicated process," Thompson said.

News of the Phase I clinical trial approval gave a lift to the publicly traded company with more than 840,000 shares changing hands on the Toronto stock exchange Friday. Its shares rose 70 cents to $5.60, the highest point since mid-November.

With the approval, cancer patients involved in the trials overseas will receive the drug intravenously, targeting not only the primary tumour sites, but also cancer that has metastasized in other areas of the body.

The goal is to determine the maximum dosage that can be tolerated by patients, the dose-limited toxicity, and the safety profile of Reolysin (pronounced REE-oh-LYE-sin).

Researchers will also watch for any effects on the tumours themselves, and patients who see some positive anti-cancer progress will have an opportunity for further doses of the drug.

Up until now, the drug has been tested by direct injections into a cancerous tumour both in mice and humans.

The drug was developed on the strength of research by former University of Calgary researcher Dr. Patrick Lee, who discovered the reovirus`s cancer-killing qualities in 1998.

Lee -- lured away by a research position with Halifax`s Dalhousie University last year -- and two of his grad students took out the first patent. They turned it over to Oncolytics in 1999. The company was formed that year with the intention of developing the treatment into a cancer therapy.

The drug is composed of the reovirus, a naturally occurring virus to which most people will have been exposed to sometime in their lives.

Reovirus has had selective success in killing human cancer cells in breast, prostate, pancreatic and brain tumours, company researchers have found. In research published in 2001 in the Journal of the National Cancer Institute, 20 of 23 mice given a single reovirus injection saw their tumours disappear.

A researcher now working with the reovirus was also cautious about over-emphasizing the drug`s capabilities.

"We`ve had lots of miracle drugs that haven`t panned out," said Dr. Penny Brasher, a biostatistician with the Tom Baker Cancer Centre.

"We are a long way" from seeing the drug available on the market, said Brasher, who worked on the initial trials in mice and is still working on ongoing trials in Calgary.

"Drug development is very, very slow."

That sentiment was echoed by Thompson, who said it could be years before the company sees the results needed to move the drug closer to approval for use in the general population.

In the meantime, Thompson cautioned against people now fighting cancer thinking the drug will be the cure-all for them.

"When we see the results, that`s when they can take hope."

Giving others hope is what Calgarian Joan Lisoway aimed for when she became the world`s first brain cancer patient to get the drug in 2002.

While Lisoway died last May, she agreed to the trial knowing any benefits in the future would come to other cancer patients and not herself.

"I could help, or not help, but not helping means I would only have a short time to live," she said in 2002.

According to Canadian Cancer Society statistics, 2003 saw an estimated 12,000 new cases of cancer, while 5,200 Albertans died from the disease.

[e-mail]

Also See: Company`s stock surges E1.

© Copyright 2004 Calgary Herald















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[merx]

http://www.royalmarsden.org/home.asp

oben der Link des Royal Marsden Hospital an dem die
Studie der 40 Patienten stattfand.

Gruß

merx

[merx]

Looking for a reported ROB TV interview with Brad. Checked Friday`s schedule and didn`t see it. Can anyone help?
A friend of mine grabbed a copy at


http://www.optamedia.com/onc.wmv


Das Interview mit Brad on ROB TV


merx

[muycaro]

In Bezug auf die anstehenden systemic trials (intravenöse Verabreichung des Wirkstoffes, beispielsweise per "Tropf"), ist es nochmal interessant diese Studie zu lesen:


Cancer Res. 2003 Jan 15;63(2):348-53. Related Articles, Links

Systemic reovirus therapy of metastatic cancer in immune-competent mice.
Hirasawa K, Nishikawa SG, Norman KL, Coffey MC, Thompson BG, Yoon CS, Waisman DM, Lee PW.

Cancer Biology Research Group and Departments of Microbiology and Infectious Diseases, University of Calgary, School of Medicine, Calgary, Alberta, T2N 4N1 Canada.

The human reovirus is an oncolytic virus that specifically targets cancer cells with an activated Ras pathway. []Because it is replication competent and highly specific for cancer cells, this virus has the potential to be an effective antimetastatic cancer agent through remote site delivery.[/b] In this study, we exploited the ability of reovirus to replicate in murine cells to test the efficacy of this virus in eliminating distal and/or metastatic tumors in immune-competent mice. We found that i.v. therapy with reovirus not only inhibited metastatic tumor growth but also led to a significant improvement in animal survival. Combining i.v. reovirus treatment with immune suppression (cyclosporine A or anti-CD4/anti-CD8 antibodies) resulted in further reduction in tumor size and a considerable prolongation in survival, compared with viral therapy alone. Combined therapy was also effective in overcoming a preexisting immunity to reovirus (a common occurrence in humans and thus a potential impediment to oncolytic effectiveness) to induce metastatic tumor regression. This is the first study to use systemic delivery of an oncolytic agent in conjunction with immune-suppressive drugs to effectively prolong animal survival. Altogether, our results suggest that i.v. reovirus therapy may present a feasible, novel alternative in the treatment of metastatic cancer in humans.



Liest sich doch gut und erweckt schon eine leichte Vorfreude auf die Ergebnisse aus England.

Vorallem auch dass der Reovirus allein und umso mehr in Verbindung mit dem Immunsystem unterdrückenden Cyclosporine zu einer "signifikanten Reduzierung der Geschwüre, bzw. deutlichen Verlängerung der Lebenserwartung geführt hat" fand ich beeindruckend.

[muycaro]

Mehr frühere Studien:


Effect of Reovirus on an Ascites Model of Human Ovarian Cancer.

In the advanced diagnosed stages of ovarian cancer (International Federation of Gynecology and Obstetrics stages III and IV), the tumor spreads throughout the peritoneal cavity or to distant sites, such as the liver and the pleural surface. To determine whether reovirus therapy is effective at this stage of ovarian cancer, we used a mouse ascites model of human ovarian cancer. CD-1 nude mice were injected i.p. with 2 x 106 MDAH2774 cells 5 days before the initiation of reovirus treatment (day 0). The therapeutic regimen consisted of one i.p. injection of 5 x 108 pfu of live reovirus or UV-inactivated virus (mock-treated control) every 2 weeks. No ascites burden was visible in reovirus-treated mice at day 28, whereas ascites formation was evident in the control mice (Fig. 5A) . Ascites tumor formation in the control mice correlated with increased body weight of these animals (Fig. 5B) . In contrast, little weight gain was observed with the reovirus-treated mice when compared with animals without tumor implantation. Furthermore, all of the control mice treated with inactive virus died by day 42 (median survival, 34.6 days), whereas 9 of the 10 live virus-treated mice were still alive after 60 days (Fig. 5C ; these animals appeared healthy even after 100 days, when they were eventually sacrificed).


Interessant ist hier wieder mal die aussergewöhliche Verlängerun der Lebenserwartung (die 10 unbehandelten Mäuse der Kontrollgruppe waren nach 42 Tagen alle gestorben, wohingegen 9 der 10 mit dem Virus injizierten nach 100 Tagen noch am Leben waren, worauf die Studie abgebrochen wurde, wer weiss wie lange sie noch gelebt hätten - das ist eine Steigerung von mehr als 100%, 200% wenn man die durchschnittliche Überlebensrate heranzieht) - abzuwarten bleibt, ob diese Ergebnisse beim Menschen wiederholt werden können, allerdings bin ich recht optimistisch, dass ONCY mit Reolysin tatsächlich den "Super-Blockbuster" der Krebstherapie gefunden haben könnte. Was das für die Patienten, bzw. für den Wert des Unternehmens zur Folge haben könnte, sollte jedem klar sein.

Bis dann, Euer muycaro

[muycaro]

21st Centurys Update von letzter Woche bezüglich ONCY.
In einem neuen, ausführlichen Report, der $99 kostet, bestehen sie weiterhin auf einem langfristigen Kursziel von $660, sollte Reolysin zugelassen werden (ist ja noch etwas in der Zukunft - zu dem Kursziel kann ich nur sagen, dass ich es in dieser frühen Phase noch "etwas" optimistisch finde, es allerdings nicht völlig ausgeschlossen ist, dass diese irgendwann mal eintrifft - allerdings müssten dafür mindestens 1 Milliarde Dollar Gewinn(!) pro Jahr auf den Tisch um ein KGV von 20 zu rechtfertigen - ok, genug gesponnen - hier nochmal der Link zu dem ONCY Kurs Berechner: http://www.canadiantreeplanting.com/onc_share_price.html).

Hier das Kurzupdate von 21st Century:


Still a buy: Oncolytics Biotech (ONCY), the Canadian company who`s developing Reolysin, the amazing compound that safely melts cancerous tumors, is up 50 cents this afternoon to $4.18, a 13% jump. This morning came news that its Phase I clinical trial to evaluate the safety of Reolysin to treat T2 prostate cancer met objectives, selectively infecting and killing tumor cells in humans without damaging surrounding healthy tissue. In one patient the prostate gland shrank by 67% after just one intra-tumor injection of Reolysin. The company also announced U.K. regulatory approval to begin a Phase I clinical trial to investigate Reolysin as a treatment for advanced metastatic solid tumors. Oncolytics was a December 2002 21st Century Investor recommendation at $1.23. At this price, with some patients, it`s still a buy.


Ich selbst bin erstmal zufrieden wenn sich der Kurs kurzfristig über $4 stabilisiert und wir dann je nach Nachrichtenlage langsam aber sicher nen paar Prozent draufpacken. Lieber etwas tiefer stapeln und sich später positiv überraschen lassen...

[muycaro]

Interview von gestern mit ONCYs CEO auf http://wallstreetreporter.com/linked/OncolyticsBiotech.html.

[muycaro]

Das Interview hatte mal wieder den typischen "low key approach", will heissen Brad war mal wieder bemüht keinen Hype anzufachen.

Was ich jedoch interessant fand waren seine Worte über den systemic trial, da fiel etwas von "aggressive enrollment" oder so ähnlich. Scheint die wollen da jetzt etwas mehr Momentum reinbringen. Die richtige Klinik dafür haben sie sich m.E. schon rausgesucht. Ergebnisse könnte es noch bis Ende des Jahres geben, so Brad, das hängt allerdings von der Geschwindigkeit des Enrollment Prozesses ab.

Ebenfalls erwähnte er den Glioblastoma (schlimmste Form von Gehirntumoren) Trial und dass hier dieses Jahr noch Ergebnisse erwartet werden dürfen.

Die Partnerschaft mit dem US National Cancer Institute soll dieses Jahr ebenso mit ersten Versuchsreihen in den USA Früchte tragen.

Schliesslich meinte Brad noch, dass je länger man nichts von einer Versuchsreihe hört, umso besser sollte man sich als Investor fühlen, da es dann meist den Patienten gutginge und man diese dementsprechend länger beobachten müsse (updates tun trozdem gut, finde ich zumindest).

Der Rest war eigentlich wie immer, eben eine Zusammenfassung was ONCY überhaupt so macht.

Ich fand es insgesamt positiv, vorallem wegen der Bemerkung, dass sie alles dafür tun, den Trial in England möglichst noch dieses Jahr abzuschliessen - das wäre natürlich phänomenal. Ausserdem steht das ja dann wohl auch für die weitere, nun etwas "zügigere" Gangart, die man ja beim Tom Baker Center unter Dr. Morris so offensichtlich vermisst hatte (in einem anderen Interview gab es auch mal einen kleinen "Seitenhieb" dazu).

So, genug Beiträge für heute(?!) - naja, jetzt habt ihr wenigstens etwas zu lesen.

[muycaro]

Hier eine Abschrift des Interviews (bereitgestellt von einem fleissigen Poster auf stockhouse.ca), Q steht immer für die zusammengefasste Frage des Moderators. Die m.E. wichtigsten Passagen habe ich fett gemacht:


Q Timeline and overview of ONC

Oncolytics Biotech was incorporated in 1998 with the purpose of investigation novel therapies for oncology or cancer. And the technical area that we are focused in is the using oncolytic viruses, which are those viruses which directly infect and kill tumor cells to attempt to derive a therapeutic benefit from that. The virus that we have been focusing most of our time and attention on is called the Reovirus. REO is an acronym for respiratory enteric orphan virus. It is one of a group of viruses that are called orphan viruses that actually don`t actually cause disease in humans, they will infect and replicate in humans but they don`t cause any defined pathology. and its a very common virus. Up to half of children by age of 12 have been infected by the virus just from environmental exposure and anywhere between 70 and 100 percent of adults show evidence of infection. The virus has an unique property, it actually exploits the most common set of genetic defects that lead to cancer to enable it to grow. And so what happens is the virus will infect any cell in your body and once its inside the cell it differentiates based on those genetic defects, whether they are there or not. And so it has the potential anyway based on the demonstrated in animal models of treating between up to two thirds and 70% of all human cancers. So its a very broad based potential therapeutic. Our program since 1998 has been directed toward ensuring we can make the product . That’s always an issue with biologics, the ability to make the product. Going through the required toxicology program. We are using a live virus and no matter how safe it is, one has to demonstrate that in a formal toxicology program. And I think we have done that to our satisfaction. And then looking at stepping into programs examining using the virus in the human stage

First of all , when you start with these kind of projects you do what is called a local therapy first. Local therapy is direct injection into tumors. So our first clinical studies, both in general cancers and in prostate and glioblastoma which is brain cancer have been all directed at looking at .local therapy where we inject the virus directly into the tumor. Subsequent to that we`ve just announced that we are moving into a more broad abased form of administration which is intravenous. The importance of intravenous administration for a viral product I think can`t be underestimated. Most cancers have a tendency once we`ve detected them to metastases or spread throughout the body and those metastatic sites, or places where the tumor has spread to can only be accessed easily by administering a product like this intravenously. And so we have basically a two pronged approach to cancer. We will continue developing local administration therapies and we`ll initiate very soon in the UK our first large scale systemic study where we administer the product systemically in hopes of being able to access treating that large body of patients where the primary tumor isn`t the problem anymore its their metastatic sites.

Q Challenges - systemic administration

Well systemic administration if an infectious agent such as a virus is always more of a challenge, more of a challenge mentally than actually from a practical perspective. The safety profile of the viral group either if you look at gene therapy or oncology any of the viruses that have been used in any of these treatments is outstanding. I mean there have been thousands, literally, of patients have been treated in all those studies and there has been an incredibly low level of what we call severe adverse events associated with the administration of it. However you have this mental perception that you are administering a live agent to a person. What we have done in the area with Reovirus is really chained ourselves, I think, to a much higher standard of examining safety with respect to administration prior to moving into human studies. Its quite typical in this field and more so with us, you see the use more species of animals used in toxicology. We use , unfortunately, primates in our studies as well as canines and rodents. We do this to ensure that we can demonstrate to people that the safety profile is as it would seem. Secondly, I think just as a practical issue, with respect to storage, transportation and use, of a live viral to use as a therapy. The end product is just sitting in an IV bag like any other IV bag which is the way you want it. And just dripped into a body over a half-hour to forty five minute period. but still there’s the precautions that’s required till people get used to handling it.... you know, handling a live infectious agent. These aren`t insurmountable challenges but certainly people have done it and we are about to start doing it systemically. They are just the sort of things you have pay attention to and focus upon to be allowed to do these things.

Q Direction of

Were actually have a three pronged approach at the moment. First , we`ll continue with our local therapy program where we continue on with our glioblastoma study. With the anticipation of being in phase 2 in the not too distant future. In that particular area. In parallel with that will be a fairly aggressive systemic delivery program, first in the UK and in other countries and where we initially look at safety and efficacy in that order and then at efficacy and safety in the other order... with respect to administration of that product. The third line of work that we will be focusing on is our collaboration with the National cancer Institute in the United States We`ll be conducting a number of studies with the NCI and our expectation is these studies will focus more on cotherapy with existing chemotheraputics or radiation therapy and that really is important to flesh out the use of the product. The standard in oncology is typically to use the products in combination with other products. For us to be able to examine very early on like this the use of these products in combination therapy is very important for the long term development of product and so those are really the three, local therapy, systemic therapy and cotherapy in collaboration with the NCI

Q 2004 Milestones?

I think people should expect to hear about our ongoing glioblastoma study in that time period, certainly the initiation of the systemic study, we`ll see if we actually have data this year that falls out of that or not. It really depends on the enrollment. and how the patients are doing. Paradoxically, in our business, the longer you don`t hear about a study generally is good news because it means the patients are doing better and you are following them longer. and thirdly I think we can certainly expect the initiation of one or more of the programs of the NCI in formal way

Q Value?

I think Oncolytics viral therapy and specifically Reovirus viral therapy really offers the possibility of being able to treat a very large percentage of human cancers with a safety profile that is certainly as good and most likely far superior to existing chemotheraputics. I think that combination is a pretty powerful story to follow and something we should pay attention to.


http://www.stockhouse.ca/bullboards/viewmessage.asp?no=75221…

[muycaro]

Wallstreetreporter hat auch eine gute (knapp gehaltene) Zusammenfassung bzgl. Oncolytics auf seiner Webseite:


Oncolytics Biotech Inc. focuses on the discovery and development of pharmaceutical products for the treatment of a wide variety of human cancers.
Headquartered in Calgary, Alberta, Canada, the Company was formed in 1998 to explore the oncolytic capability of the reovirus, a virus that preferentially replicates in cells with an activated Ras pathway, one of the most common family of genetic defects leading to cancer.

HIGHLIGHTS

Numerous successful studies completed in animal models Two human clinical trials concluded Conducting a local delivery Phase I/II recurrent malignant glioma trial Approval to commence a Phase I systemic administration trial in the United Kingdom Collaborative agreement with the National Cancer Institute in the U.S. to conduct multiple clinical trials Strong cash position Experienced management team and board of directors.

THE PRODUCT

The Company’s technologies are based on discoveries made in the 1990s in the Department of Microbiology and Infectious Diseases at the University of Calgary. The potential products are being developed using the naturally occurring reovirus for treatment of cancers in humans. The reovirus, or Respiratory Enteric Orphan virus, has been demonstrated to replicate specifically in tumour cells that have a constitutively activated Ras pathway. Activating mutations of Ras and mutations along the Ras pathway occur in approximately two-thirds of all tumours. Tumours bearing an activated Ras pathway are deficient in their ability to activate an anti-viral response mediated by the host cellular protein, PKR. Since PKR is responsible for preventing reovirus replication, tumour cells lacking the activity of PKR are susceptible to reovirus infection and eventual cell death. As normal cells do not possess Ras activation, these cells are able to thwart reovirus infection by the activity of PKR. In a tumour cell with an activated Ras pathway, the reovirus is able to freely replicate and kill the host tumour cell. Progeny virus particles are then able to infect and kill surrounding cancer cells. This cycle of infection, replication and cell death is believed to be repeated until there are no longer any tumour cells carrying an activated Ras pathway available.

THE MARKET

Approximately 1.3 million North Americans will be diagnosed with cancer in 2004, and in the same year more than half a million are expected to die of cancer. In the United States, cancer accounts for 25% of all deaths, second only to cardiovascular disease. The relative lifetime risk of a male developing cancer is 1 in 2, while for women, the risk is 1 in 3.

The costs of these diseases are also significant. In the United States, the National Institutes of Health estimate that the overall annual costs for cancer are $107 billion, of which $37 billion can be attributed to direct patient costs.

.......

Nochmal ein Kommentar dazu von einem Poster:

In his interview with the WallStreetReporter, Brad Thompson stated that Oncolytics Biotech would be taking a 3 prong approach to the development of reovirus for the treatment of cancer and that approach was:

1. local administration of reovirus ... particularly in the treatment of glioblastoma

2. systemic administration of reovirus ... for metastatic cancer (inital studies being conducted at the Royal Marsden Hospital in the UK. Further sites in other countries to be announced)

3. co-therapy administration of reovirus with chemotherapy and radiation .... collaboration on these studies happening with the National Cancer Institute (NCI). (Formal studies to be initiated with some results perhaps reported on later this year.)

Brad Thompson also stressed the ease of administration and storage of the reovirus given that the reovirus is a live virus that is easily stored at ambient room temperature and is quickly administered in an IV bag to the patient.


Kurz zusammengefasst:

3 verschiedene Verabreichungsweisen.

1. Lokal, direkte Injektion in den Tumor, speziell bei Gehirntumoren.

2. Intravenös, per Infusion, insbesondere erfolgversprechend bei metastasierenden Tumoren (siehe PR bzgl. der zugelassenen Versuchsreihe in Grossbrittannien - in der gleichen Klinik ist übrigens auch Gleevec bis hin zur Zulassung wenig später getestet worden - dort werden pro Jahr um die 30.000 Patienten behandelt!).

3.Kombinationsbehandlung mit Chemotherapie und/oder Bestrahlung, sprich die Versuchsreihen in Kooperation mit dem US National Cancer Institute (möglicherweise noch erste Resultate diese Jahr, wobei ich eher auf 1. Halbjahr 2005 tippe, sofern es keine Interim Results sind).

Und schliesslich wies Brad noch auf die einfache intravenöse Verabreichung von Reolysin hin. Der Reovirus kann ohne weiteres bei Raumtemperatur gelagert und verabreicht werden.

.....................

Ich wünsch Euch was, Euer muycaro

[muycaro]

Der Kommentar gilt natürlich dem Interview und nicht der Zusammenfassung.

[muycaro]

Und schliesslich nochmal ein Wort zur Kosteneffizienz der Herstellung des Reovirus (von matdu, Yahoo Board):



BioReliance, the company that is manufacturing Reolysin for ONCY, is a CRO (contract research organization). ONCY is simply one of its dozens of clients. How much they charge ONCY depends on a free market system. There are a # of these CRO in the US and in Canada. BioReliance does have a good reputation though.

I do agree with you that eventually ONCY needs to have multiple manufacturing sites. And that would likely be done by a future partner. All drug manufacturing facilites have to be inspected and approved by the FDA as part of the BLA approval process.

My estimated cost for the current Reolysin production in a 2-litre bioreactor that can produce up to 1-2000 doses at 10 (log9) per dose is around $100-200k or so (just a guess here). That would amount to around 1-2% of how much ONCY can charge (around $10k per treatment). A pharma partner will likely scale up production to at least 20-litre bioreactors, further increasing production capacity and lowering cost.

[muycaro]

Wer sich näher informieren will kann sich auch mal die gerade upgedatete Seite http://beatcancernow.com angucken.

[Oncolyt]

Bioreliance sind übrigens übernommen worden, ich weiss garnicht mehr von wem ; beschäftigst du dich auch mit
Genemax, muycaro, die haben ja die TAP Technologie erfunden und fangen auch in Kürze mit Phase 1 an ...

[muycaro]

Hallo. Das ist richtig, Bioreliance ist kürzlich von Invitrogen übernommen worden:

http://finance.yahoo.com/q?s=ivgn

Mit Genemax habe ich mich noch nicht beschäftigt, werde ich mir aber mal ansehen, danke.

Hier noch ein interessanter Artikel:

http://66.102.9.104/search?q=cache:stPWIA6ImRIJ:www.kidscanc…

[Oncolyt]

Hi, schau dir das ruhig mal an, Genemax ist mindestens genauso interessant wie ONCY !

P.S. Bin seit heute bei ONCY mit von der Partie, denn hier steckt möglicherweise mehr Potiential
als derzeit bei Dendreon (700 Mio Mcap.) , bei Cell Genesys (600 Mio. Mcap.)und bei Imclone (3 B. Mcap.)!!

[muycaro]

DNDN halte ich auch, aber im Vergleich zu ONCY bin ich da stark untergewichtet. Ich persönlich halte ONCY für DIE Spekulation überhaupt im im Sektor der Krebstherapie.

[merx]

Hey muycaro und die andern,

erstmals vielen Dank an Dich für die guten Infos, Du scheinst ja voll informiert zu sein. Bin seit der Geschichte mit Synsorb in Oncolytics investiert und hab
im 1,20 § Bereich den Truk geladen. Nun nehmen wir uns halt
die Zeit und schauen was da auf uns zukommt. Die Sache mit
dem Trial in London macht die Angelegenheit doch international. So viel ich weis, ist auch der Pictect Fond
in der Schweiz investiert. Wer kann da mal genau nachsehen ??? Über 1 Mio Shares sind jetzt schon in Toronto
und NY gehandelt worden. Man darf gar nicht drandenken was
mit einer solchen Firma , MK passiert wenn da die Marieee abgeht. Ihr wisst ja , das kann jederzeit sein. Shorten möchte ich diese ONC wirklich nicht. Manche sagen dies ist
so eine Aktien wie Taser, aber wir wollen nicht unsere Gedanken zu weit schweifen lassen.
Lassen wir uns ganz einfach überraschen......
Denken wir auch an jene, welche eventuell durch eine Injektion von Reolysin von der Geisel Krebs womöglich geheilt werden können.

Gruß

m e r x

[MONSIEURCB]

zum Theme ONCY - interessante Seite:
http://www.beatcancernow.com/
Gruß - Monse

[Oncolyt]

DAS ist es !!



Wir haben gerade ein unheimlich starkes, nach oben
gerichtetes Momentum in der Aktie, bei 10-fach hohem
Volumen .... !

[Blondyke]

Hi Onco, na, wie wär`s ..( )
9.Sce2

[Blondyke]

Du, Onco, was heißt`n eigentlich "PKR` im Volkesmund ..

[Oncolyt]

Willkommen Blondyke in Klondyke,

Schätze mal, daß WO dir den Maykiss gesperrt hat,weil die nicht wollen,
daß im Genemax-Forum Schach gespielt wird oder so ähnlich,
beschäftigst du dich auch mit Oncolytics ?

9.-00

[Blondyke]

Ich weiß leider nicht allzuviel über Krebsforschung, wenngleich ich doch glaube, daß die Natur gerade an neuen
Aids-Varianten tüftelt, und man deshalb mit dem Krebs bald
die Friedenspfeife rauchen dürfte ...

Nur, welcher Weg wohl der richtige ist ?!-

10.Ld2

[Oncolyt]

Der von Genemax oder der von Oncy ! - Warum ? - Weil ich die im Depot habe !! Jetzt muss ich die Partie wieder aus
dem Kopf weiterspielen, weil ich nicht mit Ld2 gerechnet hatte, sondern mit 10.Sf3. Als Antwort darauf hatte ich
den unglaublichen Zug 10.-f4!! ausgetüftelt, schau dir das mal an ...

10.-Sa6

P.S. Als "Aids-Aktie" kann ich dir Gilead Sciences empfehlen ... !

[Blondyke]

Beide, wobei mich bei der Graphik eben der Begriff "PKR"
interessiert, wieso gibt`s`n die dann nimmer, wenn der
pöse Krebs sich mal eingenistet hat.

f4 hatte ich zum Glück gesehen ...
11.Sf4

[muycaro]

Hallo Blondyke und Oncolyt,

ich finde es ja schön, dass ihr Euch beide anscheinend für Oncolytics interessiert, allerdings würde ich Euch eingehend darum bitten diesen Thread ausschliesslich zur sachlichen(!) Diskussion über Oncolytics Biotech als Unternehmen, das Management, Patente, Neuigkeiten und vorallem die Wissenschaft die dahinter steckt zu verwenden.

Wenn Ihr Schach spielen, über andere Off-Topics schreiben, oder besonders viele Smilies posten wollt, tut dies meinetwegen bitte im Genemax Forum oder macht einen Thread auf dem w:o Sofa auf.

Dies ist KEIN OTC-BB oder Hotstocks Thread (an alle zukünftigen Poster, bevor es überhaupt anfängt: sinnloses rumgepushe ist ebenfalls nicht erwünscht)!

Bis jetzt hat dieser Thread noch einen hohen Informationsgehalt und es wäre schön, wenn das auch so bleibt. Wenn Ihr nichts produktives zu Oncolytics beizutragen habt, postet lieber einmal weniger (bitte auch keine ausschweifenden Kursdiskussionen, bringt eh nichts). Nichts für ungut.



Hier eine kurze Erklärung von PKR:


Bisher lässt sich Krebs nur mit schweren Geschützen, wie z.B. Chemotherapie wirksam zu Leibe rücken. Da solche Medikamente jedoch nicht selektiv wirken, ziehen sie zwangsläufig gesunde Zellen in Mitleidenschaft (sprich Chemotherapie und Bestrahlung töten nicht nur Tumorzellen, sondern auch gesunde).

Forscher arbeiten daher seit langem an dem Ziel, Merkmale zur Unterscheidung zwischen Tumor- und normalen Körperzellen zu finden, um selektivere und damit verträglichere Medikamente zu gewinnen.

Hier kommt das Enzym PKR ins Spiel. Siehe die gepostete Grafik von Oncolyt.

Krebszellen starben bei entsprechenden in-vitro-Versuchen in großer Zahl ab, normale Zellen wuchsen hingegen völlig normal weiter. Das Virus schädigt also im Gegensatz zu herkömmlichen Krebsmedikamenten nur die Tumorzellen, nicht aber gesundes Gewebe. Bei Tests mit Mäusen wuchs ein als besonders bösartig geltender Hirntumor, ein Glioblastom, deutlich langsamer (Oncolytics ist derzeit kurz vor Beendigung seiner klinischen Phase I Versuchsreihe bezüglich Glioblastoma beim Menschen).

Die Ergebnisse machen also Hoffnung darauf, eine hochselektive Methode gefunden zu haben, die der klassischen Chemotherapie in ihrer momentanen Form deutlich überlegen wäre (Im Gegensatz zu dem Reovirus schädigt Chemotherapie leider auch im hohen Masse gesundes Gewebe, s.o.).


Viele Grüsse, muycaro

[muycaro]

Hier noch eine ausführlichere Erklärung zu PKR:

http://njms.umdnj.edu/biochemistry/fb_Gunnery_Shobha_2002.ht…

Und hier nochmal eine Zusammenfassung von Oncolytics (siehe insb. "The Product"):

http://66.102.11.104/search?q=cache:jYPu07qIeUYJ:www.biobn.com/index.cfm%3Fpage%3Dviewcompany%26CoID%3D143+pkr+%2B+cancer&hl=en&ie=UTF-8

[Blondyke]

Danke muycaro,
..und Oncolyth, wegen mir können wir gern im Genemax Forum spielen, da is`es auch ruhiger.

[Oncolyt]

Vielen Dank, muycaro,

Das wusste ich alles nicht, du scheinst dich ja gut auszukennen,
aber sag mal, was hälst du eigentlich von den aktuellen monoklonalen Antikörpern,
wie Avastin von Genentech und Erbitux von Imclone ? Schätze mal, denen sind wir haushoch überlegen, was ?!

Maykiss, wir sehen uns im G.Forum

[MONSIEURCB]

Die Zahlen sind raus!!!!

http://biz.yahoo.com/prnews/040308/to112_1.html

[muycaro]

Hallo Oncolyt, ich bin kein Experte in dem Bereich und habe deshalb diesbezüglich nochmal mit einem Freund gesprochen. Hier mal einige Gedanken zu Deiner Frage:


Erbitux und Avastin sind humanisierte monoclonale Antikörper, deren Ziel die EGF, bzw. VEGF Rezeptoren darstellen.
Sie wirken beide etwas toxisch, da die Rezeptoren ihre normalen Funktionen haben, die durch die Antikörper gestört werden.

Reolysin (ONCYs Reovirus) hat dagegen ein wesentlich besseres Sicherheitsprofil, und hat bis jetzt praktisch keine Nebenwirkungen gezeigt (ausser max. 24 Stunden anhaltenden leichten Grippesymptomen bei einigen Patienten) - wenn man sich dagegen die Nebenwirkungen von Erbitux und Avastin ansieht, sind das zwei verschiedene Welten.

Ein weiterer Nachteil der Antikörper ist, sie können sich im Gegensatz zum Reovirus nicht reproduzieren. Dies resultiert darin, dass sehr viele Moleküle bei den Behandlungen verbraucht werden müssen, was sich wiederum in den hohen Behandlungskosten von mehr als $40k pro Jahr und Patient niederschlägt (Reolysin ist bekanntlich sehr günstig herzustellen, ca. 1% vom geplanten VK kostet das Verfahren EUR 100-200 vs. EUR 10.000-20.000 gepl. VK und somit wesentlich günstiger als Erbitux oder Avastin).

Die klinischen Versuche mit beiden Antikörpern haben bis jetzt nur eingeschränkten Nutzen gezeigt: Erbitux wirkte bei weniger als 20% der wegen Colorectal Krebs (Darmkrebs) behandelten Patienten und es konnten keine Daten gesammelt werden, die auf eine eindeutig lebensverlängernde Wirkung hinweisen würden. Lediglich schrumpfte der Krebs in einigen Fällen.
Avastin hat eine lebensverlängernde Wirkung von durchschnittlich ca. 5 Monaten bei Colorectal Krebs gezeigt, also auch nicht wirklich sehr beeindruckend.
Bei der Behandlung von Brustkrebs hat Avastin in einer früheren Versuchsreihe versagt.
Reolysin dagegen hat m.E. eine gute Chance in vielen verschiedenen Arten von Krebs wirksam zu sein, vorallem in der Kombinationstherapie (wird sich in den vom NCI gesponsorten Versuchen beweisen müssen).

Ich denke dass Reolysin, sofern es funktioniert, ein wesentlich breiteres Spektrum an Applikationen, bzw. resultierend dadurch einen wesentlich grösseren Markt haben wird, als irgendwelche dieser Antikörper.
Dies sollte sich im Aktienkurs in den nächsten Jahren wiederspiegeln.

Viel Glück!

[muycaro]

An der Zulassung von Erbitux scheiden sich eh die Geister, da hier, wie zuvor geschildert, nur eine sehr limitierte Wirksamkeit nachgewiesen werden konnte.
Die FDA scheint damit die Kriterien zur Zulassung von Krebsmedikamenten deutlich heruntergeschraubt zu haben, was sich in der Zukunft dementsprechen wiederum positiv für wirksamere Präparate niederschlagen sollte.

P.S.: Volumen an der Nasdaq - Wow!

[Oncolyt]

Danke ! Danke! Genau das hatte ich im Gefühl, was du da ausgeführt hast, es sei denn die Nanotechnologie findet
noch eine bessere Methode in Zukunft, aber das kann ja noch 20 Jahre dauern ! Ich war übrigens mal in AVXT.OB
Avax Technologies drin, die mit ihren autologen Vakzinen gegen Krebs kläglich an dieser FDA gescheitert sind, bei
denen weiss man nie, was die grad im Schilde führen ...

[Oncolyt]

Und schau dir die Marktkapitalisierung und den Kurs von Genenterch an !!!
Da könnte ich nicht übel Lust bekommen mein ganzes Depot mit nur Oncolytics aufzufüllen ...

[muycaro]

Naja, zu Genentechs Verteidigung muss man sagen, dass sie ja ausser Avastin schon mehrere andere zugelassene Produkte haben, die ordentlich Geld in die Kassen bringen.
Ich persönlich halte Genentech auf diesem Niveau trotz allem etwas überbewertet.

Diversifikation ist an der Börse sehr wichtig, egal wie gut eine Story ist. Erst recht bei solch spekulativen Biotech Aktien.
Hier gibt es enorme Chancen, aber auch dementsprechend hohe Risiken.

Ich halte ONCY wie schon mal erwähnt langfristig immer noch für extrem unterbewertet/unterschätzt und für DIE Spekulation überhaupt in dem Sektor, daher ist es auch für mich manchmal (zu) schwer der Aktie nicht einen höheren Stellenwert in meinem Depot einzuräumen als ich es eigentlich mal geplant hatte.

Aus meiner Sicht hat der Wert einfach ein ausserordentliches Chance-/Risikoverhältnis. Sollte alles so laufen wie geplant, könnte man m.E. allerdings auch schon mit einigen tausend Anteilen einen sehr(!) beachtlichen Wohlstand erreichen.

Viele Grüsse, muycaro

[merx]

Hey ONC holder,

was für ein Wochenausklang sowie ein solcher Wochenbeginn.
Leute, Ihr werdet beobachten wie nun ab 5$ die Instis Blöcke zu 5,10,25 kaufen werden. Gespannt was Brad am Freitag in Zürich sagt. Sag nur Long and schtrong......

Handel in Frankfurt und Berlin noch in keinem Verhältnis zu
Toronto und NY.
Naja, wir wolln ja ONC nicht pushen, aber die Aktie scheint
am Radar entdeckt worden zu sein.


Bitte weiterso informativ im Board posten.


Gruß

m e r x

[Oncolyt]

Sehr richtig, Diversifikation !

Was macht deine Genemax Analyse, muycaro, beeil dich, heute +23 % und ich bin fett drin !

[muycaro]

Ich habe gerade nochmal eine Abhandlung gefunden, in der die Wirkungsweise, etc. des Reovirus beschrieben wird - wer sich noch nicht so gut damit auskennt, kann dort mal nachlesen:

http://www.lib.duke.edu/chem/chem110/papers/Blake%20Lamm.htm

Das Fazit der Abhandlung:


VI. Conclusion

Activated Ras signaling pathways due to direct mutations in the Ras gene as well as through genetic alterations of upstream pathway elements prove to be some of the most promising areas of gene therapy as a treatment for cancer. The mere fact that reovirus, an oncolytic agent that causes no known human disease, targets cells with such mutations provides hope to the thousands who suffer from this deadly disease. Reovirus is continuing to be examined for its ability to remotely target cancerous cells and tumors in immunodeficient as well as immunocompetent animals. In all the articles I reviewed, reovirus shows promising results as becoming an effective and efficient means of treating cancer. The issue of whether reovirus is a possible cure is still not known. In the near future, scientist hope to examine ways in which reovirus can be used to alter cancerous cells so as to improve the effect of radiation therapy and chemotherapy on cancer. Furthermore, scientists hope to begin reovirus treatment on human beings who are in the later stages of cancer development. If these treatments prove successful, reovirus may very well be one of the greatest medical discoveries in the history of medicine.

____________________________________________________





>>>>If these treatments prove successful, reovirus may very well be one of the greatest medical discoveries in the history of medicine.<<<<

[muycaro]

Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Inc. Announces Issuance of Eleventh U.S. Patent
Tuesday March 9, 8:32 am ET


CALGARY, March 9 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) ("Oncolytics") announced that it has been granted U.S. Patent 6,703,232 entitled "Method of Producing Reovirus." Claims in this patent cover producing reassorted reoviruses for the treatment of Ras-mediated tumours.

"This patent expands our portfolio of intellectual property," said Dr. Matt Coffey, Vice President, Product Development of Oncolytics. "This patent adds to previously issued patents regarding manufacturing of the reovirus."

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill human cancer cells in vitro that are derived from many types of cancer, including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

This news release contains forward looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements, including among others, the Company`s belief as to the safety and efficacy of the reassorted reoviruses, the Company`s expectations as to the potential applications of the patented technology and other statements relating to anticipated developments in the Company`s business and technologies, involve known and unknown risks and uncertainties that could cause the Company`s actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward looking statements. The Company does not undertake to update these forward looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/prnews/040309/to137_1.html

[muycaro]

Für denjenigen, den es interessiert, hier ein Link zur Patentschrift:

http://tinyurl.com/3f4cg

[Oncolyt]

|^^^^^^^^^^^^^^^|||___
| $$GO ONCY$$_||||__,___
|_..__..___..__.===|=|__|__] ] ]
(@)`(@);;````(@)*(@)******(@)+

[Oncolyt]

RAF kinase is the enzyme in the pathway that RAS activates to signal proliferation. Other kinases in this part of the growth signaling pathway include MEK and ERK. The RAS signaling pathway is triggered by activation of the RAS gene. Mutations of the RAS gene occur in approximately 20 percent of all human cancers, including 90 percent of pancreatic cancer, 50 percent of colon cancer, and 30 percent of non-small cell lung cancer. Recently researchers found that a specific RAF kinase, BRAF, is mutated in two-thirds of melanomas and approximately 10 percent of colorectal and in some other solid tumors.

P.S. Onyx Pharmaceuticals ist in Phase 3 und hat 1 Billion Mcap !!

[Oncolyt]

Damit wollte ich nur sagen, dass
Oncolytics mit hoher Warscheinlichkeit
auf dem goldrichtigen Weg ist !

|^^^^^^^^^^^^^^^|||___
| $$GO ONCY$$_||||__,___
|_..__..___..__.===|=|__|__] ] ]
(@)`(@);;````(@)*(@)******(@)+

Get to the loading dock and back up the Truck !!

[muycaro]

ONXX Medikament was Du hier ansprichst, BAY 43-9006, nutzt zwar auch die Mutation des Ras Pathways zu seinem Vorteil, ist allerdings kein selbst reproduzierender Virus wie der Reovirus, sondern eine sogenannte "small molecule drug" und hat auch eine andere Wirkungs-, bzw. Herangehensweise als Reolysin:

"By inhibiting RAF kinase, BAY 43-9006 blocks the RAF/MEK/ERK signaling pathway that is activated by the RAS gene to trigger cell proliferation.

Other inhibitors of growth signaling that have been approved by the FDA include Herceptin®, a monoclonal antibody that inhibits the HER2 receptor that is upregulated in breast and ovarian cancer, and Gleevec(tm), a small molecule that inhibits an enzyme that causes excessive proliferation of white blood cells, resulting in chronic myeloid leukemia. In addition, there are other compounds in late-stage clinical testing that target the EGF (epidermal growth factor) receptor. The receptor and the enzyme targets of these therapies activate the RAS cell-growth signaling pathway. IRESSA, now approved for non-small cell lung cancer, is a small molecule inhibitor of the EGF receptor.

BAY 43-9006 differs from existing FDA-approved signal transduction inhibitor drugs in several important ways. First, while some currently available drugs are designed to prevent signals that activate the RAS protein, BAY 43-9006 disrupts a signaling enzyme "downstream" from RAS, namely RAF kinase. Thus, BAY 43-9006 has the potential to be effective against cancers caused by abnormal external activation of RAS, as well as abnormal stimulation of growth due to mutations in the RAS gene and mutations in RAF itself, giving BAY 43-9006 a broader array of possible anticancer applications. In addition, BAY 43-9006 also has an anti-angiogenic effect through the inhibition of VEGFR-2 and PDGFR-ß. Another key differentiator for BAY 43-9006 is that it is orally active, which would be a significant improvement over drugs that must be administered intravenously, especially since these agents are often given for long periods of time."


Ausserdem hat ONXX sein Virus Programm schon vor einiger Zeit stillgelegt um sich auf seine small molecule Plattform, bzw. BAY 43-9006 zu konzentrieren:


RICHMOND, CA – June 11, 2003 – Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) today announced that the company is further prioritizing the clinical development of BAY 43-9006, a novel anticancer compound expected to enter Phase III clinical testing later this year. Based on encouraging results to date from Phase I and Phase Ib clinical trials, the company, together with its partner Bayer Pharmaceuticals Corporation, intends to pursue multiple clinical paths with BAY 43-9006. As a result, Onyx will discontinue its therapeutic virus program, resulting in a reduction in force of approximately 50 of the company’s employees, most of whom were dedicated to the virus program.

http://www.onyx-pharm.com/news/pr_061103.html


Meiner Meinung nach sind beide Technologien nicht wirklich direkt miteinander vergleichbar und ich sehe Reolysin auch als interessanter an. Einziger Vorteil von ONXX ist, wenn man schon mal Äpfel mit Orangen vergleichen will, dass sie schon in Phase III sind und mit Bayer einen starken Partner haben, wobei ich nicht weiss wieviele Zugeständnisse ONXX Bayer ggü. beim deren Marketing Agreement beim Umsatzanteil gemacht hat (Oncolytics könnte schon längst einen Partner haben, wollen allerdings einen möglichst hohen Anteil der zukünftigen Umsätze für Oncolytics selbst sichern, und haben auch genug Geld in der Kasse um noch einige Zeit damit zu warten).

[muycaro]

Allen Leuten, die sich näher mit Oncolytics beschäftigen wollen, kann ich nur den folgenden Link ans Herz legen, in dem einige interessante Beiträge zu ONCY gesammelt sind:

http://oncy.5u.com/

Es wird dort so ziemlich alles wirklich sehr umfangreich und leicht verständlich erklärt.

Ansonsten ist natürlich auch:

http://www.beatcancernow.com

sehr gut um die ersten Hausaufgaben bzgl. ONCY zu machen, wobei der obere Link noch einiges mehr enthält.

[muycaro]

Eins noch: ONXX Medikament ist wohl eher mit Gleevec, bzw. Avastin zu vergleichen, siehe vorherige Posts zu Imclone und Genentech.
Soweit ich weiss war der Virus, den sie früher entwickelten auch nicht "replication competent", konnte sich also nicht selbst reproduzieren (vergleiche mit Introgens Adenovirus).

[muycaro]

Onyx früheres Virenprogramm basierte auf genetisch veränderten Andenoviren, die sich in Krebszellen mutierte P53 Gene zu Nutze machten.
Der Reovirus ist dagegen in keiner weise genetisch verändert.

[Oncolyt]

Alles klar, muycaro, wir sind uns , was
ONCY betrifft, glaub ich , völlig einig !

ONCY hat doch 11 Patente, sind nicht darunter auch die
Verwendung des Adenovirus und des Herpes simplex Virus
gesichert, wenn ich mich recht entsinne ... ?

|^^^^^^^^^^^^^^^|||___
| $$GO ONCY$$_||||__,___
|_..__..___..__.===|=|__|__] ] ]
(@)`(@);;````(@)*(@)******(@)+

[merx]

Hey Oncolyt und Muycaro,

könnt Ihr mal nachforschen welche Fonds sich bereits für
ONC entschieden haben und ihrerseits schon Bestände haben ?

Hab mal was gelesen vom Pictect Biofond ??????

Die Mellonbank hat nen größeren Bestand. Der Teacherfond
hat seine 15000 Teil verkauft.

Bitte mal recherieren.


Merx

[Oncolyt]

TOP INSTITUTIONAL HOLDERS:

Mellon Bank, N.A. 1,315,900 Shares
Bankmont Financial Corp. 67,974 Shares
MWN Ltd. 12,875 Shares
PALO Alto Investors, LLC 10,000 Shares

TOP MUTUAL FUND HOLDERS:

Dreyfus Premier International Fds-Growth Fund 75,000 Shares
Dreyfus Variable Investment-International Equity Portf 74,700 Shares
Dean International Value Fund 23,300 Shares

[muycaro]

"Oncolytics als potentielle Heilung von Krebs" wurde neben anderen Errungenschaften der Universität von Calgary in der gestrigen Calgary Sun (kanadische Tageszeitung) erwähnt. Zwar nichts wirklich grosses, aber die Erde wurde schliesslich auch nicht an einem erschaffen:

POTENTIAL CANCER CURE
The faculty of medicine again shook the notion of what people thought they knew when they recently told the world they developed a treatment that could potentially put an end to cancer.

Reolysin, a new drug developed by Oncolytics Biotech Inc., may hold the key for cancer patients and was created using breakthroughs achieved by U of C scholars.

Calgary scientists found that viruses, such as the common cold, can effectively and selectively fight cancer cells in the human body without harm or side effects to the adjacent tissue.

http://www.canoe.ca/NewsStand/CalgarySun/News/2004/03/14/381…

[muycaro]

" Oncolytics als potentielle Heilung von Krebs"

Ups, das sollte natürlich richtig heissen "Oncolytics Medikament Reolysin als potentielle Heilung von Krebs".

In dem heute allgemein schlechten Gesamtmarkt (offensichtlich Angst vor Terrorgefahr) sieht ONCY bis jetzt zumindest ja erstaunlich stabil aus.

[Oncolyt]

Konkurrenz aus Deutschland ?

16.03.04.Das deutsch-amerikanische Biotechnologie-Unternehmen MediGene AG erhielt vom US-Patent- und Markenamt ein Patent für onkolytische (krebszerstörende) Viren.

Dieses Patent schützt eine Methode, mit gentechnisch veränderten Herpes Simplex Viren (HSV) Tumorzellen zu bekämpfen. Die Viren lösen eine lokale Infektion aus und regen dadurch das Immunsystem des Patienten an, den Tumor und Metastasen zu bekämpfen. Dieses Konzept stellt neben der tumorzerstörenden Wirkung der Viren selbst einen zweiten Wirkmechanismus der onkolytischen Viren dar.

Dr. Peter Heinrich, Vorstandsvorsitzender der MediGene AG, kommentiert: " Dieses Patent verdeutlicht erneut das Potenzial unserer HSV-Technologie, die wir entwickeln, um Krebs auf verschiedenen Wegen zu bekämpfen. Erste klinische Studien, in denen Krebspatienten mit MediGenes Herpes Simplex Viren behandelt wurden, haben bereits zu viel versprechenden Ergebnissen geführt. Das neue US-Patent erweitert MediGenes führende Patentposition im HSV-Bereich."

MediGene hat bisher zwei Varianten onkolytischer Herpes Simplex Viren entwickelt. NV1020 gegen Lebermetastasen aus Dickdarmkrebs hat eine klinische Phase 1-Studie erfolgreich abgeschlossen. Eine Phase1/2-Studie wird derzeit von MediGene vorbereitet und soll in 2004 beginnen. G207 zur Behandlung von Gehirntumoren (Glioblastom) hat eine klinische Phase 1 erfolgreich durchlaufen, eine weiterführende Phase 1/2-Studie hat MediGene im August 2003 aus finanziellen Gründen angehalten. MediGene überprüft derzeit das Projekt und ist an Partnern zur Weiterentwicklung dieses viel versprechenden Medikamentenkandidaten interessiert. Das neue US-Patent bezieht sich auf Herpes Simplex Viren, die ein gewünschtes Fremdprotein herstellen und gleichzeitig durch die Veränderung von zwei bestimmten Herpesgenen für die sichere Anwendung am Menschen abgeschwächt wurden. MediGenes G207 weist diese Merkmale auf und wird damit durch das genannte Patent geschützt.

--------------------------------------------------------------------

Tja , Muycaro, was ist denn jetzt los, ich dachte wir
haben das Patent , aber da bin ich wohl falsch informiert

Wo ist den jetzt der Unterschied zwischen Reovirus
und gentechnisch abgeschwächten HS Virus,
wie siehst du die Chancen beider Produkte im Vergleich ???

[Oncolyt]

P.S. Warum musste Onyx` früheres Virenprogramm, basierend auf genetisch
veränderten Andenoviren, eingestellt werden, was war denn das Problem ?

[Oncolyt1]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[Oncolyt1]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[muycaro]

Oncolyt, komm bitte mal wieder ein bisschen runter.
Wenn Du Dir ein bisschen Mühe gemacht hättest, wärst Du wohl auch von alleine auf die Antwort gekommen. Ich bin auch kein Guru/Alleswisser und muss die Sachen auch nachforschen.
Solltest Du Fragen haben, insbesondere so interessante (jedoch leicht paranoid formulierte - vielleicht denkst Du nochmal drüber nach, ob ONCY wirklich das richtige für Dich ist), dann schau doch bitte erstmal 5 Minuten lang, ob Du nicht selbst eine Antwort darauf finden kannst. Dann kannst Du Deine Thesen inklusive der Fragen hier posten (oder erstmal neutral bleiben) und alle haben etwas davon.


Ich bin selbst kein Patentexperte, allerdings sollte jedem klar sein, dass Patente immer sehr spezifisch sein müssen.
Das läuft eben nicht à la "hiermit patentiere ich den Nutzen aller möglichen Viren, egal wie nun die Behandlung genau aus sieht, gegen Krebs".

Oncolytics hat sich den Nutzen der verschiedenen Virengattungen, wie Reo-, Adeno- und Herpes Simplexviren (die letzteren beiden genetisch modifiziert, damit sie sich reproduzieren können, was normalerweise nicht möglich ist. Ursprünglich sind letztere beiden "replication defective", im Gegensatz zum Reovirus, der nicht verändert werden muss um sich selbst zu reproduzieren, er ist schon von Natur aus "replication competent") als potentielle Behandlung von Ras aktivierten Krebszellen patentieren lassen (Virus dringt in die Ras aktivierte Krebszelle ein, zerstört diese und vervielfältigt sich zusätzlich dabei).

Soweit ich das einigermassen richtig verstanden habe, hat sich Medigene hingegen, um es einfach auszudrücken, den Herpes Simplex Virus als Markierung der Krebszellen und deren spätere Vernichtung durch das menschliche Immunsystem patentieren lassen (Xenogenization).
Deren HSV ist auch mehrfach genetisch verändert, im Gegensatz zu dem HSV, dessen Nutzen ggü. Ras mutierten Krebszellen sich Oncolytics hat patentieren lassen, bei dem nur das Gamma 34.5 Gen verändert wurde.

Über Medigenes Ansatz weiss ich leider nicht genug Bescheid, um mich jetzt darüber auszulassen, aber auf den ersten Blick scheint Oncolytics bereits mehr als nur ein paar Schritte voraus zu sein (versuchs-, sowie patenttechnisch).
Hinzu kommt, dass ich den Reovirus als mit Abstand kompetenteste virologische Lösung dem Krebs etwas entgegen zu setzen halte, da er bereits von Natur aus selbst reproduzierend ist, was die Adeno-, bzw. Herpesviren eben nicht sind. Auch habe ich eher Bedenken bei deren Sicherheitsprofil (zumindest der unveränderte Herpes Virus ist recht aggressiv, dieses kann gentechnisch in den Griff bekommen werden, stellt allerdings eine zusätzliche Hürde da, die es beim Reovirus gar nicht erst gibt), welches bei dem Reovirus bis jetzt ja wirklich ausserordentlich ist, da es so gut wie keine Nebenwirkungen gibt.

Ich sehe hier also auf den ersten Blick keine direkten Überschneidungen zwischen den Patenten.

Hier nochmal ein Post von Yahoo bezüglich der Reproduktionseigenschaften der verschiedenen Virengattungen und Oncolytics Patentschutz diesbezüglich:


This is a copy of RJC`s reply to message number 8434 posted by drstoks regarding a medline abstract "Oncolytic viruses: clinical applications as vectors for the treatment of malignant gliomas.

Re: replication competent viruses
by: rjc2827 12/31/03 02:03 pm
Msg: 8437 of 11515
That’s an interesting abstract for a number of reasons.

One of it’s authors is Dr. JM Markert who has done the bulk of the clinical work with HSV for gliomas, who has taken an active interest in REOLYSIN for years now, and who could be the Principal Investigator for the expected US FDA Phase II REOLYSIN glio Trial.

It’s interesting because this comparative study sees that: “Much effort in the past has been placed in utilizing replication-defective viruses to this end but they have shown many disadvantages. Much recent attention has been focused on the potential of replication-competent viruses to discriminatingly target, replicate within, and destroy tumor cells via oncolysis, leaving adjacent post-mitotic neurons unharmed.”

The only way to make HSV, the adenovirus, or the vaccinia virus replication competent (but only replicating in cancer calls) is to modify these viruses such that they won’t block a cells natural (PKR) response to a virus. This particular modification is covered for both HSV, and for the adenovirus in patents granted to Oncolytics, and is the subject of a patent applied for by Oncolytics, and pending, in the case of the vaccinia virus.

rjc



Wegen der Details der Patente werden sich sicher später nochmal die Patentexperten bei den Amis zu Wort melden. Zum Teil haben diese schon Patente im Biotechbereich eingereicht und kennen sich somit besser aus.


##########################


So, bezüglich ONXX Virenprogramm könntest Du ja mal auf deren Website nachschauen, dort steht nämlich in dem entsprechenden Press Release:

Zitat:

ONYX TO FOCUS EXCLUSIVELY ON SMALL MOLECULE CANCER PROGRAM
BAY 43-9006 Takes Priority as Therapeutic Virus Program is Discontinued

RICHMOND, CA – June 11, 2003 – Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the company is further prioritizing the clinical development of BAY 43-9006, a novel anticancer compound expected to enter Phase III clinical testing later this year. Based on encouraging results to date from Phase I and Phase Ib clinical trials, the company, together with its partner Bayer Pharmaceuticals Corporation, intends to pursue multiple clinical paths with BAY 43-9006. As a result, Onyx will discontinue its therapeutic virus program, resulting in a reduction in force of approximately 50 of the company’s employees, most of whom were dedicated to the virus program. Following this reduction in force, Onyx’s remaining scientific and administrative personnel will be focused on furthering the development of BAY 43-9006. Onyx expects to record a restructuring charge related to this activity in the third quarter of this year. It is estimated that the company will save approximately $4 million on a quarterly basis. However, these savings are expected to be offset by increased clinical development expenses for BAY 43-9006 as the compound enters Phase III testing.

“Though the decision to close our therapeutic virus program was not an easy one, it was an appropriate business action,” said Hollings Renton, Onyx’s chairman and chief executive officer. “BAY 43-9006 has continued to generate positive data in clinical trials, resulting in some difficult but necessary portfolio management choices.”

Mr. Renton continued, “Without a corporate partner in the near term to share the investment needed to make meaningful progress in our therapeutic virus program, we cannot continue to fund this program as well as BAY 43-9006. At this point in time, it is important that we apportion our resources in a way that will most directly advance the commercialization of BAY 43-9006.”

According to the codevelopment collaboration between Onyx and Bayer, Onyx funds 50 percent of the development costs for BAY 43-9006. In return, Onyx will share equally in any profits generated in the United States, where the companies can copromote the product. Everywhere else in the world, except Japan, Onyx`s share of any profits will be somewhat less than 50 percent since Bayer has exclusive marketing rights. In Japan, Bayer will fund product development, and Onyx will receive a royalty based on any sales.

To date, BAY 43-9006 has been evaluated in hundreds of patients with cancer. Clinical trials include four completed Phase I single agent studies, eight ongoing Phase Ib studies combining BAY 43-9006 with different standard chemotherapies and two ongoing Phase II single agent studies. Final Phase I monotherapy results, along with data from two of the Phase Ib combination studies, were recently reported at the annual meeting of the American Society of Clinical Oncology (ASCO). Onyx and Bayer intend to conduct further clinical testing of BAY 43-9006, including a Phase III study planned for later this year.

Cancer is the second leading cause of death in the U.S. Despite its prevalence, many forms of cancer are inadequately treated with conventional approaches. Due to this large unmet medical need, BAY 43-9006 may have significant commercial potential across a number of tumor types -- either as a monotherapy or in tandem with current treatments with chemotherapeutic agents.

“Though we are winding down our therapeutic virus program, I have great faith in the ultimate potential of this novel approach. We are leaving open the option of restarting this program, either directly or in combination with outside investigators,” said Mr. Renton. “Our employees have made important scientific progress in this area, and I thank them for their numerous contributions.”

[...]

http://www.onyx-pharm.com/news/pr_061103.html




Also, kurz und bündig, ONXX spart sich dadurch im Jahr ca. $20 Millionen ein, die sie für die Entwicklung von BAY 43-9006 (von dem Bayer auch noch 50% der Entwicklung finanziert) in mehreren grossen Studien benötigen.
Sie schliessen ja dabei eine spätere Wiederaufnahme des Programms ausdrücklich nicht aus.
Eine reine Businessentscheidung also. BAY 43-9006 war weiter in der Entwicklung und wird 50% von Bayer gesponsored, also wird sich hier auf die schnellstmögliche Zulassung des am weitest entwickeltsten Produktes fokussiert (positiver Cash Flow sobald wie möglich), das soll schon öfter mal vorkommen in der Industrie.

[muycaro]

Um die Vor- und Nachteile der verchiedenen Virengattungen besser nachzuvollziehen, rate ich jedem sich mal diese Powerpoint Präsentation zu Gemüte zu führen:

http://tinyurl.com/yrypk

Für alle die kein Powerpoint haben, hier die HTML Version, die allerdings nicht so übersichtlich ist:

http://66.102.9.104/search?q=cache:W3ksWidViGsJ:duke.usask.c…

[Oncolyt1]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[muycaro]

Hallo Oncolyt,

die Patente werden eine lange Zeit vorher beantragt, bevor sie genehmigt, bzw. veröffentlicht werden. Dies dauert im Biotechbereich in der Regel 1-2 Jahre.

Was ONXX genau bewogen hat ihr Adenovirusprogramm 2003 auf Eis zu legen kann ich Dir auch nicht zu 100% sagen, ausser was ich vorher schon geschrieben habe, eben dass sie dadurch alle Ihre Ressourcen auf das Medikament, das sie mit Bayer zusammen entwickeln fokussieren können (siehe deren Press Release).

Vielleicht haben sie auch gemerkt, dass der natürliche Reovirus ihrem modifizierten Adenovirus einfach zu stark überlegen ist, oder dass sie eine Technologie von ONCY lizensieren müssten um weiterzukommen...

[muycaro]

So, ich bin ab heute auf Geschäftsreise, kann also seltener posten.
Sollte es also wieder einen `Notfall` geben, wie wenn sich z.B. Medigene den x-fach genetisch veränderten HSV auch noch zur direkten Injektion in die Lippe patentiert um diese schön `voll` auszusehen zu lassen, dann erstmal schön ruhig bleiben.
Ihr macht das schon!

Hier nochmal ein Artikel von Forbes.com über die gegenwärtige und zukünftige Preisentwicklung von Medikamenten.

Forbes.com:
Drug Prices: The Genentech Solution
Matthew Herper, 03.16.04, 4:24 PM ET

NEW YORK - If developed nations want access to breakthrough medicines, they should have to pay full price, says Genentech Chief Executive Arthur D. Levinson.

Levinson, the thoughtful scientist who has headed up the world`s oldest biotech since July 1995, weighed into the ever-raging issue of high drug costs at a March 12 meeting with industry analysts in New York. "Clearly," he said, "the dollars going into health care are going up exponentially....That can`t happen forever. The question is when is it going to implode?"

Levinson`s take: "I think the drug industry, and I`m speaking largely about big pharma here, is shooting themselves in the foot by allowing people to buy drugs in Canada for as low as 10 cents on the dollar. I almost see it as unconscionable."

While big pharmaceutical firms seem caught in a perennial public relations battle over high drug costs, their younger, hipper siblings in the biotech industry have often seemed to go unscathed. This despite the fact that biotech drugs are among the priciest around, with a single dose of Genentech`s (nyse: DNA - news - people ) new cancer fighter Avastin costing $2,200, 60% more than a year`s worth of Pfizer`s (nyse: PFE - news - people ) cholesterol pill Lipitor. That may be a fair price compared with other biotech cancer drugs, but it still boggles the mind.

In the U.S., drug companies negotiate with insurance companies that must compete with one another for customers. In Canada and Europe, national health plans have monopolistic buying power. If the pharmaceutical industry wants to sell its wares to Canadians, it must go through the Canadian government. Not surprisingly, American insurers are willing to pay a much higher price than the Canadian government. And many Americans pay retail price for their medicines. The result is that drugs are much more expensive in the United States than in countries with price controls in place. So much more expensive, in fact, that many blockbuster medicines reap most of their sales stateside (see: "The World`s Best-Selling Drugs"). "The U.S. is subsidizing the rest of the world," Levinson said. "There`s no doubt about that."

It`s worth noting that Genentech does not sell any of its drugs internationally. Most are marketed outside the U.S. by Roche, which owns a majority stake in the South San Francisco-based biotech. Moreover, Levinson said, his firm`s medicines are not much cheaper elsewhere than they are in the U.S. But Levinson says that if he had the choice, he would "draw a line in the sand." A country that refused to pay a fair price for a medicine simply wouldn`t get it. Levinson said it`s unfair to allow some countries to get drugs on the cheap just because the U.S. pays a great deal. Moreover, he added, if all drugs were sold at those cut-rate prices, the incentives that drive medical innovation would vanish.

That argument may sound harsh--it would deny breakthrough medicines to entire nations. But it only takes one step further the drug industry`s inevitable response to drug re-importation, one measure being widely discussed to cut American drug costs. In a March 11 research note, Richard Evans, a pharmaceuticals analyst at Sanford C. Bernstein, argued that drug giants such as GlaxoSmithKline (nyse: GSK - news - people ), Merck (nyse: MRK - news - people ) and Bristol-Myers Squibb (nyse: BMY - news - people ) can easily get around re-importation. Even re-imported drugs, Evans noted, would need to have their manufacturing processes checked by the U.S. Food and Drug Administration. The drug giants could simply make sure Canadian drugs included one manufacturing step that was not FDA approved. "Bring it on," Evans wrote.

The real danger to the drug industry, Evans wrote, is that the U.S. government might be given more power to negotiate drug prices. Congress could accomplish that merely by deleting a single paragraph from the Medicare bill it passed last year. "If re-importation distracts legislative attention from this more dangerous topic," Evans wrote, "all the better."

[muycaro]

Oncolytics Präsentation vor Institutionellen Investoren, Fondsmanagern und Vertretern grösserer Pharma- und Biotechkonzerne (potentielle Partner) nächste Woche wird live im Web übertragen:

Press Release Source: Oncolytics Biotech Inc.


Media Advisory - Oncolytics Biotech Inc. to Present at Invest Northwest CEO and Investor Forum
Thursday March 18, 12:37 pm ET


CALGARY, AB, March 18 /PRNewswire-FirstCall/ - Dr. Brad Thompson, Chairman, President and CEO of Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY), will present a corporate overview to institutional investors, pension fund managers, pharmaceutical and biotech corporate partners and other financial professionals at the Invest Northwest CEO and Investor Forum in Bell Harbor International Conference Center in Seattle, Washington on Tuesday, March 23, 2004 at 12:00 p.m. PT.
ADVERTISEMENT


A live audio webcast of the presentation will be available at: http://www.videonewswire.com/event.asp?id=21398 or www.oncolyticsbiotech.com the company`s website. It is recommended that listeners log on 15 minutes in advance of the presentation to register and download any necessary software.

An audio replay of the presentation will begin three hours after the presentation time and will be available until March 31, 2004 at www.oncolyticsbiotech.com.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill human cancer cells in vitro that are derived from many types of cancer, including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

The webcast time is subject to change. This release and the presentation related thereto contain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control and which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or expectations implied by these forward-looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/prnews/040318/to281_1.html

[merx]

http://dtp.nci.nih.gov/docs/ddg/ddg_current.html


schaut`s euch mal das an !!!!!!!!!!!!!!!!!
ganz unten

no comment .............


wou...........


die shorties wer`n brenna


merx

[MONSIEURCB]

..sozusagen "PHASE 3 DER SHORTY-VERNICHTUNG"! Klingt gut...

[muycaro]

CBS Market News erwähnen ONCY:

Oncolytics Biotech (ONCY: news, chart, profile) is another name well positioned to rise. The shares approached 52-week highs Monday after carving out a sizeable five-month base. Initial support around $5.00 represents the breakout point.

http://tinyurl.com/372ku

[muycaro]

Hier der Link zu Brads Präsentation:

http://www.videonewswire.com/event.asp?id=21398

[Oncolyth10]

!

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[Oncolyth11]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[Reolysator7]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[muycaro]

Privatplatzierung durch einen europäischen institutionellen Investor - langfristig m.E. auf jeden Fall ein guter Schritt, da es weitere ca. $10M in die Kriegskasse spülen kann + Vertrauensbeweis. Kurzfristig (bis spätestens 7.4.) könnte es eine kleine Euphoriebremse darstellen, was vielleicht auch mal ganz gut ist?!:


ONCOLYTICS BIOTECH INC. Quick Quote: ONC 6.68 (-0.03)


Oncolytics Biotech Inc. Announces $6.73 Million Private Placement
3/24/04

CALGARY, Mar 24, 2004 (Canada NewsWire via COMTEX) --
Oncolytics Biotech Inc. (`Oncolytics`) (TSX: ONC, NASDAQ: ONCY) announced today that it has entered into a private placement with a European institutional investor. Subject to regulatory approval and upon completion of the transaction, Oncolytics will issue 1,077,1dw
00 common shares and 538,550 common share purchase warrants for aggregate gross proceeds of $6,731,875. Each whole common share purchase warrant will entitle the holder to acquire one common share of Oncolytics upon payment of $7.75 per warrant. The private placement is anticipated to close on or about April 7, 2004. Oncolytics will use the proceeds from the private placement for general corporate purposes.

The securities to be issued by Oncolytics have not and will not be registered under the United States Securities Act of 1933, as amended (the `1933 Act`), or the securities laws of any state of the United States, and may not be offered or sold in the United States absent registration or an applicable exemption therefrom under the 1933 Act and the securities laws of all applicable states. This press release is not an offer of securities in the United States.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN(R), its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics`researchers have demonstrated that the reovirus is able to selectively kill human cancer cells in vitro that are derived from many types of cancer, including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN(R) was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN(R).

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company`s expectations related to the private placement of the units as to progress in the clinical trial program and the Company`s belief as to the potential of REOLYSIN(R) as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, ability of the Company to complete the private placement on the terms set forth in its agreements, the Company`s ability to obtain regulatory approval for the offering, the availability of funds and resources to pursue Research and Development projects, the efficacy of REOLYSIN(R) as a cancer treatment, the success and timely completion of clinical studies and trials, the Company`s ability to successfully commercialize REOLYSIN(R), uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward- looking statements. The Company does not undertake to update these forward- looking statements.

/NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES. ANY FAILURE TO COMPLY WITH THIS RESTRICTION MAY CONSTITUTE A VIOLATION OF U.S. SECURITIES LAW./

VIEW ADDITIONAL COMPANY-SPECIFIC INFORMATION: http://www.newswire.ca/en/releases/orgDisplay.cgi?okey=56839

For further information: For Canada: Oncolytics Biotech Inc.: Doug Ball,210, 1167 Kensington Cr NW, Calgary, Alberta T2N 1X7, Tel: [phone],Fax: [phone], www.oncolyticsbiotech.com; For Canada: The Equicom Group:Joanna Longo, 20 Toronto Street, Toronto, Ontario M5C 2B8, Tel: [phone] ext. 233, Fax: [phone], jlongo(at)equicomgroup.com; ForUnited States: The Investor Relations Group: Gino De Jesus or Dian Griesel,Ph.D., 11 Stone St, 3rd Floor, New York, NY 10004, Tel: [phone],Fax: [phone], theproteam(at)aol.com
News release via Canada NewsWire, Toronto 416-863-9350 -MC-


http://www.stockhouse.ca/news/news.asp?newsid=2213574&tick=O…

[schachi]

nochmals news... diesmal ein private placement... eigentlich dachte ich ja die hätten genügend money bis 2006, well...

http://www.stockhouse.com/news/news.asp?newsid=2213574&tick=…

grüße
schachi

[muycaro]

Ich sehe das so:
Vor einigen Wochen standen wir noch deutlich(!) unter $4 (US). Jetzt will jemand ca. 1 Mio. Aktien für umgerechnet ca. $4,66 pro Aktie kaufen.
Ich denke das spricht für sich.

Die Warrants können bei ca. $5,80 ausgeübt werden, was weitere Millionen in die Kasse spülen kann.
Ich denke hier wird langfristig ein solides Fundament gelegt, sowohl im finanziellen Sinne (wir haben bald immerhin fast $1 Cash/Aktie, mit dem die Versuchsreihen forciert werden können), als auch für den Kurs, zumal die Verwässerung durch diese Massnahme nur ca. 3%, bzw 4,5% nach Ausübung der Warrants beträgt.

Kurzfristig also vielleicht etwas unerwartet, langfristig allerdings vollkommen legitim und sinnvoll.
Wenn man sich die Platzierungen vor dieser anschaut, sieht man, dass die institutionellen hier langfristig einen extrem guten Schnitt gemacht haben (siehe Mellon Bank).
Da ONCY für mich eine langfristige Spekulation darstellt ist m.E. alles im grünen Bereich.

Viele Grüsse, muycaro

[muycaro]

Abschrift von Brads Präsentation letzter Präsentation:

Our technology focus is very specific and narrow. We are looking at oncolytic viruses. So those are viruses that actually actively infect and kill cells primarily through a replication cycle and are specifically reaching cancer cells. And I’ll be going into some detail about the percentage of different cancers that actually have that state. We measure everything we do against a so-called optimum drug profile which makes it handy to structure a talk around so I’ll be discussing some of the elements on this list during this talk.

The virus is one of those viruses that differentiate not on cell surface antigens but based on different metabolism found inside the cells. The natural environment for this virus which is a very common environmental virus. About up top half of 12 year old children will have actually evidence of being exposed to this virus in the environment, and anywhere up to 70 to 100 percent of any adults population will have antibodies to this virus. The natural cell environment is rapidly growing cells either in the lungs or the bowels. The primarily source of infection (and this is before lunch I know) is fecal oral so fecal contaminated water which is ingested or inhaled which is very common unfortunately. And as I stated a pseudo RAS activation found in those rapidly growing cells that line the lung or bowel and these are shed pretty much daily. And that s the natural reservoir for the virus. Obviously were putting the virus in places you don’t ordinarily get in the environment. And how the virus works is that it will actually attach onto any cell in the body it actually enters primarily through binding onto salacic acid residue its internalized and once its inside the cell it will differentiates between a cell that doesn’t have RAS activation in which case it doesn’t grow or one that does.

The virus is a very rapid killer. Eighteen to twenty four hours after infection we typically see death and then the virus ,which is an uncommon thing with viruses and you have to get used to that with viral therapies, actually produces more drug. And so each time we get up to to twenty thousand progeny virions which then infect the surrounding tissue. And its a little odd dealing with these viruses any of the companies that work with oncolytic viruses that are replication competent in fact what you put in really doesn’t matter because once it gets an active replication course You get systemic spread and spread to other tumor masses. So the hallmark of these therapies is that if you inject into one tumor, two weeks later some other tumor will start shrinking on you. Which is kind of an interesting prospect. This virus exploits a condition that is extremely common in cancers. Activated RAS pathways are implicated in at least two thirds of cancers and that number keeps going up every year. And of course that provides an interesting challenge when you are trying to design clinical studies.

Imagine a product the t certainly in the lab when you are screening or in animal models work on pretty much everything to a high degree. The percentage does vary from cancer to cancer. Cancers that tend to be more aggressive that have a higher tendency to metastasize have a higher percentage. Particularly pancreatic cancer, some of the brain cancers that we are interested in, metastatic liver are typically in the 95 to 100% range for all of the cancers. The major carcenoma groups; non small cell lung, prostate , breast, and so on are all in the 65 to 75% range. So from the technical scientific perspective extremely broad basis for therapy. And like I said that does provide some challenges when you are trying to develop clinical studies. RAS can be activated either through mutations at RAS which varies from cancer to cancer or mutations with anything upstream from RAS such as an over-expression say of EGFR, in an ???? kinase ??? any of those things will cause a state of RAS activation and that leaves the virus able to grow and kill specifically those cancers.

One thing that we are very interested in a product that looks this broadly active is working with the common ways people administer the product. Certainly, as I’ll be describing, we’ve, done several intratumoral or intracerebral clinical studies and we are about to start our first big intravenous administration study. And again this a hallmark of the viral therapies you investigate a variety of different routes of administration because most of the viruses under investigation have very broad theraputic basis. It again also drives the study design in the fact that because they are live infectious agents we tend to be driven by safety concerns. And as a group, if you look at all the gene therapies and all the oncolytic viral therapies , some several thousand patients have now been treated and less than ten serious adverse events for that entire group with all the viruses clustered together. Notwithstanding that, the regulatory agencies with which we deal are very cautious with these viruses and so what you typically see is clinical trial pathways that set out with localized superficial tumors head and neck- something I’ll be discussing- moving onto deep single tumors and then moving on to an intravenous. So its sort of a lateral clinical path driven by safety. As a result you will see incredibly large size safety packages in animals -unfortunately we do primates and dogs and rats.- and you look at all the different routes of administration at extremely high dosages. And another hallmark is you often find that you never reach a dose limiting toxicity which is kind of interesting. Or often never see any sorts of adverse events. The toxicology’s sort of odd in this case too because really the true case of toxicology in looking at cancer patients where the virus reproduces. 10^7 viruses for example in an animal that doesn’t have any tumor burden doesn’t mean much. But if you put 10^7 viruses into an animal with a large tumor burden or a human and through those you have 10^13 or 10^14 viruses floating around its just a different perspective based on toxicology. I mean imagine a regular small molecule that has a known ????? ???? ??? based on the amount od drug you stick in somebody in a toxicology program. It certainly does complicate our lives quite a bit.

We have been fortunate to have derived a very broad patent coverage. We currently have eleven US patents issued. We filed world wide of course. And the claims that we’ve got cover all the areas certainly of interest to us. Two that we’d like to draw peoples attention to it is possible actually to engineer other viruses in some cases to actually be RAS selective in their growth you can actually prevent your adenovirus and herpes virus from growing in cells that aren’t RAS activated. We have patent claims issued in that area and we have a large family in behind with the intention of trying to stretch our patent life out ot 30 or 40 years as versus 15 or 20.

Again in the viral area something that we tend to focus on more than other people, in biologics is the ability to make the product. This has been a hurdle for a number of the viruses to get into large scale systemic studies. So a lot of time and attention paid to this. Just briefly - and we use Viral Alliance outside of Washington DC - to do our total manufacturing and we have been able to achieve very high productivity so you get a little bioreactor has enough to produce product for large scale pivotal studies. And that is very important and certainly has been something that a number of our collaborators are very interested in.

Looking from a clinical development strategy. Our strategy from the start has been to start out with local administration of superficial tumors, which I’ll discuss, move to deep intratumoral administration and then move to systemic administration. And of course we are interested in systemic administration primarily because it accesses the great majority of cancer patients. But In our case specifically there is some indication that most and some people claim all -I’m not willing to go that far- metastatic disease have an activated RAS component. ?? ?? ?? ??So when you think you have 3 or 4 million patients worldwide in western Europe, the United States, and Japan that could benefit from a therapy selected for metastatic disease is a prime driver for us to be interested in this area. We will continue on of course with our local intratumoral program in some cases and our NCI collaboration which I’ll discuss I think will be focused mostly on regional arterial administration to specific areas in combination studies.

Two years ago we announced our first results from programs of phase 1 studies as an anti-tumoral study or a starting point on safety these patients had all had multiple chemotherapy most had had radiotherapy and surgery. And it was a standard dose escalation study. We were doing a single multiple injections into large superficial tumors. Tumors up to 10 cm by 10 cm which are ???? big tumors. We didn’t find any severe events or dose limiting toxicology again a hallmark of this area. And we were pleased - and this is measured two dimensionally - at 30 % regression - so thats 50 % three dimensionally we actually saw what we called viral activity which is a nice way of saying the tumor shrank that much we saw clinical response. We ??? ?? this response in this heavily pretreated population. And for interest going forwarsd as I mentioned we would often see effects where weeks later a tumor physically away from the tumor will start to shrink and that effect would go on for months and months. So its kind of an odd case where you inject a tumor and it might go completely away which we had in a number of cases and two weeks later a tumor 3 or 4 cm away starts to shrink and then a month later something up the arm or up the torso starts to shrink. Its a very very again different process than what you normally see with standard chemotherapy or radiotherapy. I show the picture -and it doesn’t, show up very well on the screen- not to show the tumor shrank , which it did, but to show the fact that around the tumor we are not seeing any necrosis. And again this is a hallmark of this therapy. We were extremely selective ???? within tumors. Often we would see 20, 30, 40 or 50% of what we thought was the tumor mass left over. It never grows back .It never starts growing again. And when you do wedge? biopsies let you find there isn’t any tumor in it what is left is just connective and support structure. And you just don’t see that in standard chemothreapy or radiotherapy because you are killing all the surrounding tissue. We have never seen that in the case of this. It is extremely selective to the point where you have cell to cell contact where you have a healthy cell sitting beside a dead cancer cell and you don’t see any cross effects. Its quite gratifying to actually see that.

Now after our first superficial tumor study we went to deeper tumors which are T2 prostate cancer patients. And it is gratifying to hear Gleason scores being discussed because people hardly ever talk about Gleason scores. Just so people understand these Gleason patients even though its early its early prostate cancer usually sort of 7,8,9 Gleason scores. This is an efficacy end point ??? and histopathology which is why we were calling it our phaseless clinical study Life-span extension wasn’t the intent. We were doing a single transrectal administration of the virus directly into the gland. Which was extremely uncomfortable and two weeks after that we were still doing the prostatectomy which is the standard therapy for T2 prostate cancer. We were looking for histopathological evidence of both cell death and certainly apoptotic cell death with this virus in the tumor and in the surrounding tissue. We found absolutely no evidence in the surrounding tissue as I mentioned cell to cell contact in damage to surrounding tissue. And we saw apoptosis- it was a very small study six patients- in 4 of the six patients. Interestingly enough in the two week period we had one patient had an extremely strong clinical response but there was no evidence of apoptosis which we are still scratching our heads about. That patient’s gland shrank by about two thirds and the PSA went back to normal and he was a little distressed actually to have to have his gland still out because that was the protocol. We are actually seeing strong evidence of T-cell infiltration into the site. And we think now there may be a secondary immune effect after the primary oncolytic effect and that may explain the very long duration tumor shrinkage that we saw in our original phase 1 study.

We currently in Canada have an ongoing Phase 1 -2 glioblastoma multiforma study we are using multiple recurrent glioma patients have a median survival of less than three months. And we are doing a steriocastic single administration into those tumors and that study is still ongoing and still enrolling. We filed in the United States with the FDA to do a similar protocol but with an improved delivery technology. The standard today is ???? diffusion into tumors versus steriotactic injection so my expectation is that once that US study is approved then we will circle back into Canada and use that improved technology there as well. We are measuring primarily safety and survival in that study. Tumor response is interesting again we observe we infect the tumor with the virus it doesn’t necessarily shrink on imaging. You open it up and there is nothing there but it still looks like a tumor. And of course we are measuring Karnofski which is standard in this area.

Late last year we announced we had signed an agreement with the NCI in the United States they will be supporting up to five clinical studies in the United and their interests are focusing on combination therapies and either regional or systemic work. And they are currently screening the virus in combination with all the standard chemotherapies. We’ve seen quite good evidence of synergy and super-additive effects with the virus plus other chemos and we have also seen that effect with radiotherapy in a number of our patients in our clinical studies. And once the NCI has done the background work which we are encouraging them to do then we expect later this year to actually announce which clinical studies they will be performing with us.

And finally systemic studies. As I mentioned for us this is the largest potential patient population. You are talking literally millions of patients with metasties that are likely to be available for this particular product. The product is extremely well tolerated which is also an area of focus with systemic studies in viruses. Some of our colleague viruses in other companies have shown spiking fevers and cytokine cascade effects. And we haven’t seen any of this in animals. We’ve treated them daily for up to 28 days at extremely high doses - enough to run very large clinical studies - and we haven’t seen any effects and that’s in canines and unfortunately primates. We’ve seen very good effects in animals with metastatic disease. And I hate to use the C word but you see that sometimes. And of course we’ve seen initial indications of virus tumor to tumor spread in our other study. The first systemic study and this is actually is a phase 1 with a phase 2 component embedded in it is going to be done in the UK at the Marsden. The Marsden is a very good site as a single site - this is a plug for them because they see about 30 thousand new patients a year at that one site- so its a very good place to run early stage studies. And this will be a standard dose escalation study with a repeat therapy component for those patients that have benefit so we will keep treating these patients as long as they keep showing benefit. The patient profile will be heavily weighted toward lung and liver cancers with a subset of pancreatic cancer. Later this year we will be filing in the United States to do a similar study that will be more weighted to tissue sarcoma so we will get a slightly different patient profiles.
Just in summary, Oncolytics trades on the TSE and on NASDAC. And we have enough cash to take us


http://www.stockhouse.ca/bullboards/viewmessage.asp?no=76332…

[Oncolyt111]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[merx]

Hey Oncys,

heut geht aber die Marieeee ab...........


Schtrong bei (bayrisch)


Gruß

merx

[r.schaui]

+ 15 % und über 1 Mio Aktien an Nasdaq und in Toronto gehandelt

[MONSIEURCB]

@merx:
Stiermassig-pfundid-damisch-gamsig-ULTRA-SCHTRONG-BAI!!!!

Tja, langsam wachen wohl einige auf...schön für uns!

[sauerback]

SK 6,20$ ha nicht schlecht.

[muycaro]

3/31/2004 - 4th Annual European C21 BioVentures Conference
Dr. Brad Thompson, Oncolytics President and CEO presenting at the 4th Annual European C21 BioVentures Conference in London, U.K.

Hallo, ich denke mittlerweile (wie auch schon vor einiger Zeit mal anklingen lassen) fangen langsam an einige Institutionelle aufmerksam zu werden (vergleiche durchschnittliche Handelsvolumina März `04 mit den Monaten davor), kann mich aber natürlich auch irren.
Da der 31. März das Quartalsende darstellt, sollten wir wohl bald mehr wissen (dann mal auf der Nasdaq Webseite nachschauen).
Ich hoffe nur das Ganze ist kein sich in den Kinderschuhen befindlicher Übernahmeversuch ohne dass jemand etwas davon merkt.
So, muss jetzt weg, versuche die Tage mal wieder öfter hier reinzuschauen, kann aber nichts versprechen.
Enjoy the ride!

[muycaro]

Die ersten Politiker springen auf...

Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Appoints Mr. Jim Dinning to the Board of Directors
Tuesday March 30, 8:30 am ET


CALGARY, March 30 /CNW/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) (`Oncolytics`) today announced the appointment of Jim Dinning to the Board of Directors.
"Mr. Dinning`s experience as a director and board member in a number of public companies and other organizations, combined with his extensive experience from his service in provincial government, will add additional depth to our Board," said Dr. Brad Thompson, President and CEO of Oncolytics.

Mr. Dinning is currently executive vice-president, TransAlta Corporation. Prior to joining TransAlta in 1997, Mr. Dinning held several key positions during his 11 years as a member of the legislative assembly of Alberta, including his term as provincial treasurer from 1992 to 1997. Today, he serves as a director for a number of public, private and not-for-profit entities including Finning International Inc., Shaw Communications Inc., Western Financial Group, the Banff Centre, Canada West Foundation and the CD Howe Research Institute. He was the chair of the Calgary Health Region from 1999 to 2001. He has been recognized for his achievements with a Distinguished Service Award from the Institute of Chartered Accountants of Alberta and an honourary doctor of laws from the University of Calgary.

"It`s exciting to be engaged with an Alberta-based company in its development of new cancer therapeutics," said Mr. Dinning.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN(R), its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN(R) was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN(R).




http://www.newswire.ca/en/releases/orgDisplay.cgi?okey=56839

For further information

PLEASE CONTACT: For Canada: Oncolytics Biotech Inc., Cathy Ward, 210, 1167 Kensington Cr NW, Calgary, Alberta, T2N 1X7, Tel: [phone], Fax: [phone], [e-mail], www.oncolyticsbiotech.com
For Canada: The Equicom Group Inc., Joanna Longo, 20 Toronto Street, Toronto, Ontario, M5C 2B8, Tel: [phone] ext. 233, Fax: [phone], [e-mail]
For United States: The Investor Relations Group, Gino De Jesus or Dian Griesel, Ph.D., 11 Stone Street, 3rd Floor, New York, NY, 10005, Tel: [phone], Fax: [phone], [e-mail]



--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/cnw/040330/oncolytics_appointmnt_1.html

[muycaro]

ONCY wird heute zum zweiten Mal auf CBS Market Watch erwähnt (letztes Mal genau vor einer Woche):

Company Symbol Mon Close Support Resistance
Oncolytics Biotech ONCY $6.18 $5.45 New High

Profiled last Tuesday, Oncolytics Biotech (ONCY: news, chart, profile) broke substantially higher Monday. It was the Nasdaq`s tenth-leading percentage gainer posting a single-day advance of 17.1 percent.

Though admittedly extended on a near-term basis, the longer-term picture will favor further gains barring a break below the former March high at $5.45.



http://finance.yahoo.com/q?d=t&s=ONCY

[merx]

http://www.aims.ca/Prevevents/dinning.html

der neue Mann an Board von ONC.


Good look.........



m e r x

[muycaro]

Gute Beziehungen können nicht schaden.
Dass Dinning anscheinend gute Kontakte in die Verwaltungsebene der Provinz Alberta hat (ehemaliger langjähriger Schatzmeister) könnte ebenso hilfreich sein, wie sein Wissen in Finanzfragen. Immerhin wird ONCY hoffentlich in nicht allzu ferner Zukunft gerade dort fähige Köpfe benötigen (horrende Dividendenzahlungen an merx und mich ausrechnen, etc. ).

Falls jemand die Seite noch nicht kennt, hier nochmal eine gute Gesamtübersicht für neue Investoren:

http://oncyedu.info

[merx]

http://ragingbull.lycos.com/mboard/boards.cgi?board=ONCY&rea…

Auszug aus dem Ragingbullboard,
interessant das untere Drittel.

IMHO

merx

[muycaro]

Nettes Publikum morgen auf der Präsentation (Lehman, Nomura, Warburg, etc.) - with real deep pockets it seems:

The mission of the 4th Annual European C21 BioVentures (EC21) conference is to educate all stakeholders in the bioscience industry about the trends that are driving its growth and development in the 21st century. The conference was first held in 2000 in London to serve the financial community. In 2002 and 2003, the conference moved to Munich and was hosted by the Bavarian Ministry for Economic Affairs, Transport and Technology. Since then, it has evolved into an annual gathering to explore the future of bioventure investing. EC21 will attract leading technology gurus, investors and company executives to meet informally to exchange ideas and to review the business goals of innovative new companies in the fields of biotechnology, informatics, medical devices and healthcare services.

EC21 BioVentures Advisory Board: (likely to attend)
3i Deutschland
Apax Partners
Atlas Venture
Capital MSL
DVC Deutsche Venture Capital
Earlybird Ventures
F&C Management
Ferghana Partners Group
Global Healthcare Hedge Fund
HBM Partners
Index Ventures
Investor Growth Capital
Lehman Brothers
Nomura International
Quest Management
Techno Venture Management
Warburg Pincus

The audience is inclusive of all the stakeholders in the future growth and development of the global bioscience industry. Representatives from a broad spectrum include: senior executives from leading life science and IT companies, entrepreneurs, scientists, technology transfer experts, investment fund and asset managers, investment and commercial bankers, corporate finance specialists, equity analysts, venture capitalists, high net worth private investors, representatives of stock exchanges, regional bioscience associations, and government officials working in the area of technology and industrial development. In addition, a limited number of representatives from leading service providers and the media will also attend.

[muycaro]

Aus dem englischen ADVFN.com Board (noch unbestätigt, suche noch nach der ursprünglichen Quelle, melde mich später): Oncolytics lässt Reolysin jetzt auch in Grossbrittanien produzieren:
Gleich $8 US!

RNS Number:3277X
Cobra Bio-Manufacturing PLC
05 April 2004


For Immediate Release 5 April 2004



COBRA BIOMANUFACTURING PLC

COBRA SIGNS AGREEMENT TO MANUFACTURE REOLYSIN(R) FOR ONCOLYTICS BIOTECH INC

Keele, UK: Cobra Biomanufacturing plc (AIM: CBF), the international manufacturer
of biopharmaceuticals, today announces an agreement with the Canadian
biotechnology company Oncolytics Biotech Inc. ("Oncolytics") for the production
and supply of an anticancer product, REOLYSIN(R), based on Oncolytics`
proprietary formulation of the human reovirus. The programme includes GMP
manufacture and long term supply through further Phase I and then Phase II
clinical trials.

Oncolytics develops anti-cancer products, based on its reovirus technology. This
agreement provides Cobra with an opportunity to participate in the development
of Oncolytics` first product based on it`s proprietary formulation of the human
reovirus: REOLYSIN(R).

Cobra will use its expertise in the development of virus manufacturing
strategies and analytical development to provide GMP manufacturing services for
the clinical evaluation of REOLYSIN(R).


David Thatcher, Chief Executive of Cobra, said:

"We very much look forward to helping to provide the manufacturing needs of
Oncolytics. The agreement will lead to the production of virus for further
clinical trials of a product that has already shown exciting results in
pre-clinical and Phase I trials. Cobra is delighted to have the opportunity to
apply its experience to this innovative product, which is being developed by
Oncolytics. This agreement potentially covers production of multiple batches of
analytical development to provide GMP manufacturing services for the clinical
evaluation of REOLYSIN(R) over the next few years and can add significant value
to Cobra`s income stream."


Dr. Brad Thompson, President and CEO of Oncolytics, said:

"Cobra Biomanufacturing will provide us the additional manufacturing capability
required to meet our anticipated clinical trial needs, their capabilities and
experience make Cobra a great fit with our manufacturing requirements."

[muycaro]

Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Inc. Appoints J. Mark Lievonen to the Board of Directors
Monday April 5, 11:13 am ET


CALGARY, April 5 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) (`Oncolytics`) today announced the appointment of Mark Lievonen, President of Aventis Pasteur Limited, to the Board of Directors.
ADVERTISEMENT


"With his experience leading Canada`s premier vaccine company, Mr. Lievonen brings substantial background in biopharmaceuticals and I am very pleased with his appointment to the Board of Directors," said Dr. Brad Thompson, President and CEO of Oncolytics.

Mr. Lievonen is currently the President of Aventis Pasteur Limited and responsible for the company`s operations in Canada. The company is at the forefront of innovation in vaccine research and development in Canada. Prior to his appointment as President, Mr. Lievonen was Senior Vice President and General Manager of the Oncology Business Unit. He was responsible for developing the strategy and funding of Aventis Pasteur`s cancer vaccine program and the global marketing and sales of cancer immunotherapeutic products. Mr. Lievonen holds a Bachelor`s Degree in Business Administration and an MBA from York University and received his Chartered Accountant designation in 1981 while working with Coopers and Lybrand. He is a member of the Board of Directors of BIOTECanada and served as Chair from January 2000 to May of 2003. He was also Chair of the Steering Committee of the BIO 2002 International Biotechnology Exhibition. In 2003, he was appointed as a Director of the Ontario Genomics Institute Board and Cabinet Member of the United Way of Greater Ontario Board, chairing the Health Care Division.

"Oncolytics has a novel approach to cancer therapy and is working hard to bring their research forward," said Mr. Lievonen. "I look forward to working with the Oncolytics team to develop this innovative Canadian company."

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/prnews/040405/to228_1.html

[muycaro]

Über das neue Mitglied unseres Board of Directors (kommt aus der Führungsriege von Aventis!):


Cancer’s answer
By Donna Bailey Nurse
Photography by Edward Gajdel

CA Mark lievonen is president of Canada’s biggest vaccine maker. He’s leading the search to find a cure for one of humanity’s most frightening illnesses

On a typical weekday morning J. Mark Lievonen steps out of his comfortably elegant home in Unionville, Ont., and slips into his midnight blue 2001 Saab SE convertible. He drives south down Kennedy Road to Highway 407 then along Bathurst to Steeles. If he is lucky and beats the traffic, by 7:15 he will arrive at the offices of Canada’s largest vaccine producer. Once inside, the president of Aventis Pasteur Ltd., the Canadian arm of Aventis Pasteur, grabs a cup of coffee and a quick breakfast at the cafeteria before making his way to his spacious office. On this particular day, he takes a two-hour conference call with his boss, Wayne Pisano, executive vice-president of commercial operations for Aventis Pasteur worldwide. Joining them on the line are the presidents of Aventis Pasteur International and Aventis Pasteur US. Given that Canada makes up only 2% of the pharmaceutical market, it tickles Lievonen to think that the Canadian branch is on an equal footing with the Europeans and the Americans. “That, in itself, reveals a lot about the unique position of this company,” he says.

Aventis Pasteur Canada is part of an international operation that employs some 8,000 people worldwide, 1,100 of them in Canada. Founded in 1914 as Connaught Laboratories, it was acquired by Institut Mérieux in 1989 and was part of a 1999 merger that formed Aventis SA, an international conglomerate that generates more than 17.6 billion euros ($26.6 billion) annually. Aventis Pasteur Ltd. (Canada) now distributes vaccines to combat 17 diseases, including the flu. But the company is best known for Pentacel, a childhood vaccine that provides single-injection protection against five diseases, including pertussis, polio, Hib (haemophilus influenza b), diphtheria and tetanus. Researched and developed wholly in Canada, Pentacel was launched in 1997 and commands 100% of the Canadian pediatric market.

In Canada Aventis Pasteur occupies 50 acres on the northern fringes of Toronto, along with two floors at Sunnybrook Medical Centre, where much of the research takes place. And this past summer, Aventis Pasteur opened a state of the art facility to house Lievonen’s pet project: a cancer vaccine program. “We are a company that deals with preventing diseases and saving lives,” says Lievonen. “For the past 15 years we have been working on a vaccine for HIV. And now, when you look at an area like cancer, we will also be treating disease. We feel that we are making a difference in the world.”

Lievonen sounds like one of those impassioned Doctors Without Borders. But he is not a medical professional. He is a CA. Lievonen’s circuitous route to the presidency of one of Canada’s most respected pharmaceutical companies describes a steep and unique learning curve, incorporating finance, marketing, health and science. According to Lievonen, his CA training has supported him every step of the way.


“I can’t speak highly enough about my CA education,” he says. “The general business training [it] provides is far greater than most people realize. It has given me the ability to reason, the ability to assess, the ability to strategize. It’s tremendous.”

Hired by Coopers & Lybrand in 1979 — after graduating from York University with a BBA — Lievonen earned his CA designation in 1981. He spent the next two years in the firm’s tax department and, in 1983, Connaught Laboratories invited him to join their treasury department. (Also, in 1984, Lievonen returned to York University and earned an MBA in marketing finance, which he completed in 1987.) Connaught had been one of Lievonen’s clients at Coopers & Lybrand, where he had also audited McNeil Laboratories. “I just happened to be in the pharmaceutical industry by default,” he says. And he readily admits he wasn’t the world’s best tax accountant. “I prefer the big picture,” he says. Still, Lievonen must have been doing something right, because in 1988, when he was just 32, he was appointed corporate vice-president of finance. Lievonen was ecstatic with the promotion. “I felt tremendous,” he remembers. “It had always been one of my goals to be vice-president of finance.”

But 1990 was his watershed year. That’s when Lievonen was named senior vice-president of commercial development and administration. He was now responsible for both Canadian and international sales and marketing. He went from a background in finance to running marketing and sales. “I remember going home and telling my wife, Lori, about my new job,” he recalls. “She said, ‘but you’re an CA, and you have nothing to do with finance anymore?’ She started laughing and I could hardly keep a straight face myself.”

Lievonen’s CA training provided him with the confidence to make the transition smoothly. “It’s that broad finance training and business analytical skills that one can apply to many situations,” he explains. “Let’s say I am presented with a proposal around the discontinuation of a product or a price change or a distribution agreement somebody wants to sign. Or say somebody comes in here with a business analysis. If the person has done a really appropriate job around the objectives, the alternatives and the recommendation, I’ll use my big picture skills to assess the plan and we can be done in three and a half minutes. On the other hand, if the analysis is poor, then I can focus in on the details. I will drill down and drill down and send the person away to try again.”

Lievonen stands five foot eleven. He wears wire-rimmed glasses and has gray hair that in bright sunlight glints blonde. At 47, he has the kind of features that promise never to age and a manner to match: loquacious and enthusiastic, Lievonen radiates energy.

Indeed, he comes across as so young and unpretentious, so frankly nice that his superiors once worried he might not have the leadership mettle required to rally the troops and move the company forward. They didn’t need to be concerned. “Mark’s boyishness is not really an issue,” says Nancy Simpson, Aventis Pasteur Ltd.’s manager of external communications. “He’s got a very serious side. He really gets down to business very quickly. I can generally determine what mood he’s in by what he is wearing. I prefer to meet with him when he’s in a polo shirt than when he is wearing a shirt that is starched and white. Believe me, there’s a real difference.”

Lievonen has given some thought to what makes for effective leadership since his elevation to the presidency in March, 1999. “I used to work on developing an external kind of toughness,” he admits. “But now I say to myself that it’s good to be positive, firm, fair and respectful. I usually find I can send a stronger message when I need to by just doing it in a very calm way.”

By any standard, Lievonen’s approach to business has been an indefatigable success. Besides holding the position of president, he is a member of Aventis Pasteur’s global commercial operations management, a group that consists of the presidents of the three main parts of the company — the American, Canadian and French — who get together to plot Aventis Pasteur’s global strategy. He’s on the board of directors of BIOTECanada, director of the Ontario Genomics Institute, and a cabinet member of the United Way of Greater Toronto, chairing its healthcare division. “What impresses people most about Lievonen,” says Janet Lambert, president of BIOTECanada, the association that represents the country’s biotechnology firms, “is his leadership skills. He is well known and respected throughout the industry. He’s a champion of the industry.”

Lievonen’s impressive career has not been won at the expense of family. He has striven tirelessly to recreate for his children — Holly, 13, and Jeff, 18 — the security and support he fondly remembers from his own suburban Toronto upbringing. Lievonen was born in Rexdale, Ont., in 1956 and looks back at a childhood that was traditional and happy, very “Leave it to Beaver.” His father, a marketing manager, and homemaker mother indulged a typical Canadian kid’s love of sports, especially hockey. Unfortunately, he was not much of a skater, and by his teens, he turned to more cerebral pursuits. He played in a band, The Pink Elephant, before more serious academic interests took hold (the band lasted about a year).

He did have a unique passion as a teen: business. While most young men his age were flipping through comic books and watching horror flicks, Lievonen was devouring The Wall Street Journal. He was mesmerized by business and political novels. “Business resonated with me,” he says. “I don’t know why. Even now, business magazines are pleasurable things for me to read: learning about people and what they have created.”

Lievonen excelled in school, graduating third in his class and winning a scholarship to York University. If he had any thoughts of sowing a few wild oats at York, they were quickly dismissed on the first day of orientation. He was stopped in his tracks by Lori Walters, a drama major and the woman who would become his wife.

Lievonen had always envisioned a career in corporate law. But while in his third year at York, studying business, he attended a career seminar that altered this plan. A chartered accountant from Price Waterhouse was on hand to address the students. “I was quite stimulated by what this individual had to say,” Lievonen recalls. “He talked about the career options for CAs, the potential income, the exposure to different opportunities. I thought, ‘I can go to law school and it will take me three more years, and if I do well I’ll get an articling position. And then if I do well I might get to work somewhere. On the other hand, I could study to become a chartered accountant and pretty much have my choice of firms.’ ”

He was right. After graduation, Lievonen landed interviews with 12 accounting firms and was offered 10 jobs. Coopers & Lybrand’s north Toronto office was a perfect fit. Lievonen is a man of dizzying global ambitions, yet steadfast in maintaining the middle-class values that have served him so well. A devoted family man, he has tried to secure a settled lifestyle for his growing family. Last year, he took time off from work to join his daughter on a school camping trip and found time one year to coach three baseball teams, one for his daughter, and two for his son.

“It’s important,” he says. “My parents always showed up to watch my games. At the time it was like, ‘Don’t stand out so much.’ I mean, my parents were always there. But when I look back on it, it was great. So that work/life balance has been important to me right from the beginning. I try my best to manage it.”

By 1995 there was a great deal to balance in Lievonen’s day-to-day life. He was on the verge of spearheading one of the most ambitious projects in Aventis Pasteur’s history: the research and development of a cancer vaccine. “Mark, along with a scientist named Michel Klein, had the original vision for the cancer program,” says Irene Marson, director of oncology business at Aventis Pasteur. “And Mark made it happen.”

Aventis Pasteur had started debating the possibility of developing a cancer vaccine after the success of BCG, a therapy that proved effective in the treatment of superficial bladder cancer. Lievonen, in charge of commercial operations at the time, was asked to lead a strategic review to determine whether it made any sense to parcel BCG into its own company.

At the same time, in a laboratory in Troy, NY, Virogenetics Corp., a company affiliated with Aventis Pasteur, was developing another cancer vaccine technology. Lievonen’s review suggested that BCG was too narrow a platform for a spinoff and the entire vaccine technology needed to be considered. The trick for Lievonen was to transfer this cutting-edge research to Canada. He had long envisioned establishing a full-fledged cancer vaccine facility on the Connaught campus of Aventis Pasteur in Toronto. If he could pull this off, Aventis Pasteur would become an industry leader in one stroke.

On the other hand, not everyone at Aventis Pasteur embraced the idea of the cancer program. “Some people thought it was a great idea,” Lievonen recalls. “But others didn’t want to hear about it. They felt we had enough on our plates dealing with infectious diseases.”

One of Lievonen’s particular gifts is his ability to pull disparate groups together. “This is important in an industry that develops everything from canola to vaccines to discovering a cure for Parkinson’s to methods of cleaning up oil spills,” explains Lambert. And Lievonen knew how to cut to the chase, to bring everyone together for a focused analysis of the looming challenge. All that was at stake were the lives of millions of cancer sufferers and the fate of several hundred million dollars in research funding.

“There were two main questions,” Lievonen says. Should Aventis Pasteur be involved in cancer vaccines in the first place? Success might be some way off, but the financial cost of such groundbreaking research and development would be great and immediate. If Aventis Pasteur decided to take the risk, where should it locate the program? The US has the largest pharmaceutical market in the world, France claims a large number of skilled researchers and all three countries have facilities for clinical studies.

“After a lot of analysis and discussion,” Lievonen says, “we decided Aventis Pasteur should go into cancer vaccines and that we should do it in Canada.”

The key to winning acceptance for bringing the program to Toronto turned out to be a financial commitment from the federal government, which was willing to contribute substantial funding through a federal agency called Technology Partnerships Canada. Aventis Pasteur would be spending a whopping $350 million over 10 years, but Technology Partnerships Canada promised to ease the pain, contributing $60 million over the same period.

In June 1997, then prime minister Jean Chrétien officially announced the agreement at a news conference held at Aventis Pasteur’s Toronto offices. Lievonen was appointed senior vice-president and general manager of the oncology business unit. He was now charged with finding a cost-effective way of transferring the cancer program from Troy to Toronto. He settled on a most excellent plan. Cutting right to the chase, he helped convince Jim Tartaglia, a chief inventor of the made-in-the-USA technology, to come to Canada.

“It was an example of the reverse brain drain,” Lievonen says. “We had challenges bringing a leading US scientist to a better position here. It took a lot of effort around remuneration and special incentives. The Canadian government likes to talk about the innovation agenda. But at Aventis Pasteur we really live it.”

Tartaglia, vice-president of research and development, arrived in Toronto in January 1999. “I wanted to come because I’d been part of the organization since 1990,” says Tartaglia, “and because I had invested my scientific career in the development of recombinant vaccines for infectious disease and cancer. That, coupled with the involvement of technology Partnerships Canada. I was also excited about the research team we would be building at Aventis Pasteur.”

Lievonen’s new cancer vaccine facility employs 50 scientists busily researching and developing a therapeutic vaccine that will help strengthen the body’s immune system — a crucial step in fighting the disease. To date, the program has produced two candidate vaccines — one to treat colorectal cancer and another to fight melanoma. They are currently in phase one/ two clinical trials in humans. “What we are looking for,” Lievonen says, “is safety and the ability to stimulate an immune response. Once you have that, you move to phase three, which is where you really start looking for a clinical benefit or efficacy over the next few years.”

Under Lievonen’s steady hand, Aventis Pasteur has fulfilled its promise as an industry leader in vaccine research and development. But this laudable goal does not compare to what truly spurs him on. “Many people forget about the diseases that were scourges of mankind,” he submits. “Polio in the ’50s was absolutely devastating. We’ve gotten complacent about immunization. It has been so successful that people no longer recognize the need.” Lievonen’s mission is to ensure the general public understands this need will always be present and stay alert to the possible reappearance of any number of diseases. “A few years ago,” he offers as an example, “there was an issue over whooping cough vaccine — it was being linked to certain disorders. Some communities in the US and England stopped vaccinating and there was a resurgence of the disease.”

Sadly, Lievonen has seen even more spectacular and devastating evidence to support his near-evangelical call for vigilance and continued research. “Today, SARS and the West Nile virus are bringing infectious diseases back into our consciousness,” he says.


http://www.camagazine.com/index.cfm/ci_id/19137/la_id/1.htm

[r.schaui]

muycaro, können die beiden Meldungen von heute (#201 und #202)alleine eine derartige explosion auslösen ?? allein heute an Nasdaq und in toronto über 10 % aller aktien gehandelt, können das fonds bewirkt haben - oder sind evtl schon ergebnisse aus den klinischen Tests durchgesickert ??? was meinst du ??
r.schaui

[muycaro]

#194 von muycaro 30.03.04 11:54:36 Beitrag Nr.: 12.594.217 12594217
Dieses Posting: versenden | melden | drucken | Antwort schreiben
3/31/2004 - 4th Annual European C21 BioVentures Conference
Dr. Brad Thompson, Oncolytics President and CEO presenting at the 4th Annual European C21 BioVentures Conference in London, U.K.

Hallo, ich denke mittlerweile (wie auch schon vor einiger Zeit mal anklingen lassen) fangen langsam an einige Institutionelle aufmerksam zu werden (vergleiche durchschnittliche Handelsvolumina März `04 mit den Monaten davor), kann mich aber natürlich auch irren.
Da der 31. März das Quartalsende darstellt, sollten wir wohl bald mehr wissen (dann mal auf der Nasdaq Webseite nachschauen).
Ich hoffe nur das Ganze ist kein sich in den Kinderschuhen befindlicher Übernahmeversuch ohne dass jemand etwas davon merkt.
So, muss jetzt weg, versuche die Tage mal wieder öfter hier reinzuschauen, kann aber nichts versprechen.
Enjoy the ride!



Wie schon vor ein paar Tagen angemerkt, denke ich dass hier Institutionelle akkumulieren. Zumindest die gehandelten Volumina sprechen stark dafür (vergleiche Volumina März 04 mit den Monaten davor, bzw. heute ist das Volumen das höchste jemals gehandelte überhaupt).

Die Meldungen von heute hatten m.E. damit wenig zu tun, da der Kurs schon vorher nach oben geschossen ist.
Ich hatte vor kurzem auch mal angemerkt, dass ich nicht hoffe, dass dies der Beginn einer (unbemerkten) Übernahmeschlacht ist.

Die Aufnahme eines der Aventis (die wohl kurz vor einer möglichen Fusion mit Novartis stehen, wobei sich dort zwei der Grössten in der Forschung, Herstellung und Vermarktung von Krebstherapien treffen) Topmanager ins Board of Directors von ONCY ist unerwartet.

Man kann derzeit wohl nur spekulieren, was hier hinter den Kulissen abgeht. Dass irgendwelche News durchgesickert sind, halte ich für nahezu unmöglich, da ich die IR von ONCY mittlerweile recht gut kenne. Die "Big Boys" mögen da natürlich etwas andere Vorraussetzungen haben.

Fazit:
Ich würde sagen es sind institutionelle Käufer plus die Bewertung ist einfach zu niedrig gewesen und viele kleinere haben sich eingedeckt.

Dazu kommt, dass eventuell demnächst News anstehen (Glioma Ph I Ergebnisse, Start des Enrolment von den Trials in London, Start der Versuchsreihen in Zusammenarbeit mit dem US National Cancer Institute in den USA, weitere Patente, eventuell Analystencoverage, etc.).

Solch hohe Volumina + stark ansteigende Notierungen wie heute rufen natürlich auch Day- und Swingtrader auf den Plan (long und short), die für weiterhin SEHR hohe Volatilität (Schwankungsbreite des Kurses) sorgen dürften (heute zwischen $7,20 und 9,80 - mir ist fast das Herz stehen geblieben, schliesslich bedeutet jeder Cent(!) hoch oder runter für mich hunderte von Euro).

Ich halte meine Position langfristig und freue mich natürlich über den Kurszuwachs, den ich im übrigen für gerechtfertigt halte wenn ich mir das Potential von Reolysin vor Augen halte (siehe der Share Price Calculator) - ich meine das ist der Grund warum ich Oncolytics damals überhaupt mal gekauft habe: ausserordentliches Chance-/Risikopotential und die Möglichkeit einer sprichwörtlichen Revolution in der Krebstherapie (selektive Wirkungsweise, kaum Nebenwirkungen, etc.).

Viele Grüsse, muycaro

[muycaro]

Wegen Übernahmespekulationen - das ist es was mich z.B. die Stirn runzeln lässt:

SUBJECT: Lievonen appointment Posted By: rtim
Post Time: 4/5/04 12:56
« Previous Message Next Message »

Interesting appointment in that Bill Cochrane was also recently appointed to the board. Lievonen and Cochrane were colleagues at Connaught Laboratories before it was bought out by Merieux... which became Aventis.
Cooincidental??? I doubt it.



http://www.stockhouse.ca/bullboards/viewmessage.asp?no=77009…

[r.schaui]

muycaro, danke für deine ausführlichen statements, kannst du auch etwas über die aktionärsstruktur von oncolytics sagen
danke, r.schaui

[muycaro]

Darüber kann ich nichts 100%iges sagen.

Ich denke, die meisten Aktien liegen immer noch in den Händen der "kleineren" Investoren, auch wenn diese zum Teil mehrere 100K bis 1000K Aktien halten (viele lokale Investoren aus der Gegend um Calgary).

Ansonsten befanden sich nach meinen Informationen bis vor kurzem ca. 15-20% des Floats in institutionellen Händen, obwohl auf der Nasdaq Webseite nur ca. 6% ausgewiesen wurden (mittlerweile?).

Viele der Aktien werden natürlich auch von "Kleinstanlegern" wie Dir und mir gehalten. Da sich die Oncolytics Story immer mehr rumzusprechen scheint, decken wir hier mittlerweile alle 5 Kontinente ab.
Und jeder erzählt mal nem Bekannten was und der kennt zwei weitere... Viele Aktien dürften also in mehr oder weniger festen Händen um die Welt verstreut liegen.

Schlussendlich sind dann noch die Day- und Swingtrader, von denen wir wohl einige während dem Anstieg der Wochen mitgenommen haben.

Die Führungsriege (BT, MC, DB, etc. und das BOD) von Oncolytics selbst hält noch einige Millionen an Optionen (dürften so gute 3 Mio. sein).

Ansonsten einfach mal ab und zu auf der Nasdaq Webseite vorbei schauen - könnte schon demnächst überraschen, so denn die Big Boys ihre Bestände auch reporten.

Eines noch: je mehr Aktien bei den Instis liegen, desto mehr "Spielchen" bezüglich dem Kurs werden gespielt werden, um ein paar Reihen Stopps aufzusammeln, etc.
Man sollte sich im Klaren darüber sein, welche Ziele man mit einer Spekulation auf Oncolytics Erfolg anstrebt (kurzfristige Spekulation: Disziplin bewahren, Schwankungen ausnutzen - schwierig, nichts für mich, zumindest nicht bei diesem Wert, langfristig: eigenes Chance-/Risikoprofil ermitteln und nur soviel investieren ohne das man immer noch gut leben könnte), bzw. sich auf einige wilde Tage in der Zukunft vorbereiten.

Viele Grüsse.

Hier nochmal der Link zu einigen der ONCY Info-Seiten (sehr informativ und hilfreich):

Zusammenfassung:
http://oncy.5u.com/

Reolysin/Reovirus:
http://www.beatcancernow.com

Share Price Calculator:
http://www.canadiantreeplanting.com/onc_share_price.html

[muycaro]

Hier noch mal die Quelle zu Post #201, damit auch alles seine Richtigkeit hat:

http://www.cobrabio.com/prs/050404.htm

Cheers!

[muycaro]

Aktuelle Shortposition in ONC (Kanada):

Short History
Symbol Report Date Volume Change
ONC - T 2004-03-31 563,055 220,414

ONC - T 2004-03-15 342,641 49,675

ONC - T 2004-02-29 292,966 12,036

ONC - T 2004-02-15 280,930 29,383

ONC - T 2004-01-31 251,547 39,810

ONC - T 2004-01-15 211,737 27,700

ONC - T 2003-12-31 184,037 13,500

ONC - T 2003-12-15 170,537 -70,980

ONC - T 2003-11-30 241,517 -19,483

ONC - T 2003-11-15 261,000 60,500

ONC - T 2003-10-31 200,500 -391,401

ONC - T 2003-10-15 591,901 -214,199

ONC - T 2003-09-30 806,100 248,016

ONC - T 2003-09-15 558,084 182,384

ONC - T 2003-08-31 375,700 -305,400

ONC - T 2003-08-15 681,100 400,900

ONC - T 2003-07-31 280,200 13,406

ONC - T 2003-07-15 266,794 7,194

ONC - T 2003-06-30 259,600 94,503

ONC - T 2003-06-15 165,097 99,631

ONC - T 2003-05-31 65,466 -31,860

ONC - T 2003-05-15 97,326 29,242

ONC - T 2003-04-30 68,084 30,269

ONC - T 2003-04-15 37,815 -47,385

ONC - T 2003-03-31 85,200 25,000

ONC - T 2003-03-15 60,200 -96,900

ONC - T 2003-02-28 157,100 100,100

ONC - T 2003-02-15 57,000 1,200

ONC - T 2003-01-31 55,800 -4,500

ONC - T 2003-01-15 60,300 22,400

ONC - T 2002-12-31 37,900 5,000

ONC - T 2002-12-15 32,900 10,974

ONC - T 2002-11-30 21,926 7,526

ONC - T 2002-11-15 14,400 8,156

ONC - T 2002-10-31 6,244 -27,156

ONC - T 2002-10-15 33,400 28,300

ONC - T 2002-09-30 5,100

ONC - T 2002-09-15 5,100 -13,200

ONC - T 2002-08-31 18,300 4,700

ONC - T 2002-08-15 13,600 300

ONC - T 2002-07-31 13,300 13,300

ONC - T 2002-06-30 -59,000

ONC - T 2002-06-15 59,000 -69,700

ONC - T 2002-05-31 128,700 -198,800

ONC - T 2002-05-21 327,500 47,900

ONC - T 2002-05-15 327,500 47,900

ONC - T 2002-04-30 279,600 142,200

ONC - T 2002-04-15 137,400 52,700

ONC - T 2002-03-31 84,700 28,100

ONC - T 2002-03-15 56,600 1,300

ONC - T 2002-02-28 55,300 -19,200

ONC - T 2002-02-15 74,500 -83,600

ONC - T 2002-01-31 158,100 -252,179

ONC - T 2002-01-15 410,279 405,179

ONC - T 2001-12-31 5,100 -6,000

ONC - T 2001-12-15 11,100 8,400

ONC - T 2001-11-30 2,700

ONC - T 2001-11-15 2,700

ONC - T 2001-10-31 2,700 -8,500

ONC - T 2001-10-15 11,200 -6,704

ONC - T 2001-09-30 17,904 7,404

ONC - T 2001-09-15 10,500 6,600

ONC - T 2001-08-31 3,900 47

ONC - T 2001-08-15 3,853 -1,147

ONC - T 2001-07-31 5,000 -7,500

ONC - T 2001-07-15 12,500 -1,300

ONC - T 2001-06-30 13,800 -1,300

ONC - T 2001-06-20 15,100 10,200

ONC - T 2001-06-15 15,100 10,200

ONC - T 2001-05-31 4,900 -3,600

ONC - T 2001-05-15 8,500 -44,900

ONC - V 2001-02-06 33,800 20,652

ONC - V 2001-01-05 13,000 9,100

ONC - V 2000-12-21 3,900 300

ONC - V 2000-12-06 3,600 -1,100

ONC - V 2000-11-21 4,700 -8,400

ONC - V 2000-11-06 13,100 12,323

ONC - V 2000-10-19 777 777

ONC - V 2000-10-05 -544

ONC - V 2000-09-07 3,238 1,438

ONC - V 2000-08-21 1,800

ONC - V 2000-08-04 1,800

ONC - V 2000-07-20 1,800

ONC - V 2000-07-07 1,800 -2,500

ONC - V 2000-06-21 4,300

ONC - V 2000-06-06 4,300 1,501

ONC - V 2000-05-19 2,799 1,199

ONC - V 2000-05-04 1,600 600

ONC - V 2000-04-20 1,000 -1,244

ONC - V 2000-04-07 2,244 2,044

ONC - V 2000-03-21 200

ONC - V 2000-03-06 200 -100

ONC - V 2000-02-22 300 300

ONC - V 2000-02-07 -940

ONC - V 2000-01-20 940 940

ONC - V 2000-01-07 -1,800

ONC - V 1999-12-21 1,800 1,800


Die Position wuchs also mit dem Anstieg immer weiter an und überschritt vor ein paar Tagen die 500.000 Aktien Marke. Jetzt ist nur die Frage, ob noch mehr dazugekommen ist, oder ob diese Positionen schon wieder eingedeckt wurden und die letzten Tage ein Shortsqueeze waren.

[muycaro]

Na, ONCY Fans, alles gut bei Euch?!

So, das Private Placement wäre damit dann also auch durch (bin jetzt nur noch gespannt an wen die Stücke gingen - Mellon? Ave....?):


CALGARY, April 8 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX: ONC,
NASDAQ: ONCY) announced today that it has closed its previously announced
private placement. Oncolytics issued 1,077,100 common shares and 538,550
common share purchase warrants for aggregate gross proceeds of $6,731,875.
Each whole common share purchase warrant entitles the holder to acquire, on or
before October 7, 2005, one common share of Oncolytics upon payment of $7.75
per warrant. All of the securities issued in connection with this private
placement are subject to a four-month hold provision.
An adviser retained by Oncolytics received a commission of 7.0% of the
gross proceeds and was issued 107,710 common share purchase warrants. Each
common share purchase warrant entitles the holder to acquire, on or before
October 7, 2005, one common share of Oncolytics upon payment of $7.00 per
warrant. Oncolytics will use the proceeds from this financing for general
corporate purposes.
After giving effect to this transaction, Oncolytics has 28,577,739 common
shares issued and outstanding.
The securities to be issued by Oncolytics have not and will not be
registered under the United States Securities Act of 1933, as amended (the
"1933 Act"), or the securities laws of any state of the United States, and may
not be offered or sold in the United States absent registration or an
applicable exemption therefrom under the 1933 Act and the securities laws of
all applicable states. This press release is not an offer of securities in the
United States.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the
development of REOLYSIN(R), its proprietary formulation of the human reovirus,
as a potential cancer therapeutic. Oncolytics` researchers have demonstrated
that the reovirus is able to selectively kill human cancer cells in vitro that
are derived from many types of cancer, including breast, prostate, pancreatic
and brain tumours, and have also demonstrated successful cancer treatment
results in a number of animal models. Phase I clinical trial results have
indicated that REOLYSIN(R) was well tolerated and that the reovirus
demonstrated activity in tumours injected with REOLYSIN(R).

http://www.oncolyticsbiotech.com

[merx]

Hey muycaro und die andern,

ich wills euch verraten wer das PP bekommen hat.

Es ist bei mir gelandet. (Nur a kleins Späßle).

So Leute wie gehts weiter ???

Denke, daß unsere ONC immer bekannter wird. Die amerikanischen MM versuchen auf Teufel komm raus SL-Orders
auszulösen um an die begehrten Shares zu kommen. Wir haben
ja schon Geduld bewiesen und werden diese auch künftig haben.
Denke wir werden heute gegen 9$ gehen.

Gruß

merx

[Oncolyth222]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[muycaro]

Freut mich zu hören.
Oncolyt, hast Du Dich neu angemeldet (da andere ID, oder bist Du jemand anders).

Falls >Du< es bist:

Nochmal bzgl. Onyx und warum die ihr Virenprogramm damals erstmal auf Eis gelegt haben - ich weiss jetzt den definitiven Grund (wusste ich damals eigentlich auch, aber das war mir irgendwie entfallen, man wird auch nicht jünger).

Das war nicht nur wegen Einsparung von Ressourcen um sich auf BAY... zu konzentrieren, sondern hauptsächlich deswegen, weil sie ihren genetisch veränderten Adenovirus nicht in ausreichenden Mengen für die Versuchsreihen, geschweige denn für die Vermarktung hätten herstellen können. Oncolytics hat damit mit seinem natürlichen Reovirus offensichtlich kein Problem.


Viele Grüsse, muycaro

[Upgeni_Chucklolnykov]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[Upgeni_Chucklolnykov]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[merx]

http://www.netmba.com/econ/micro/supply/curve/

Schaut`s euch mal diesen Link an.

Dies kann passieren,wenn sich die Shortis eindecken müssen.



merx

[muycaro]

Lesenswerter Barrons Artikel aus der New York Times über den Biotechsektor:

Monday, April 19, 2004

INVESTING IN HEALTH

Ripe for the PickingLittle biotech firms are catching the eye of Big Pharma. Juicy stocks?
By BILL ALPERTIN

BIOTECH, IT`S A GREAT TIME to be small.

Patents will soon expire on some of the pharmaceutical industry`s blockbuster drugs, and there isn`t enough in the industry`s own development pipeline to fill the breach. So Big Pharma is on the lookout for any little firm with a good-looking molecule.
"The pharmaceutical industry is desperate for molecules," said Alexander Kamb, a Novartis cancer researcher speaking at a recent panel at the MIT Sloan School of Management. Another speaker predicted that half of Big Pharma`s drug pipeline would come from licensing deals within five years, up from about a quarter now.
Yet only a small number of biotechnology firms have clinical test results to show a prospective bidder. Such validated products are commanding top dollar in recent license deals and acquisitions. In December Pfizer paid $1.3 billion in cash for Esperion Therapeutics, a tiny firm with a drug that boosts levels of "good" cholesterol; the price was 54% above Esperion`s stock-market value. Less than a year after Amgen committed more than $200 million to license potential cancer drugs from Tularik, Amgen decided last month to buy Tularik outright for $1.3 billion in Amgen stock -- a premium of 40% over the market value.
The drug industry committed 50% more dollars to licensing deals last year than in 2000, according to estimates by Recombinant Capital, a consulting firm in Walnut Creek, Calif. Over the same period, the volume of drug-industry acquisitions of biotech companies approximately doubled in dollar terms.
That`s a thrilling trend for investors in the smaller biotech stocks. Over the 12 months ended March, the Nasdaq Composite Index rose 49% and the large-capitalization Amex Biotech Index rose 58%. But the 200-odd stocks tracked by Recombinant Capital -- half of which have market caps of less than $300 million -- had a median gain of 106%.
The runup has left biotech stocks quite pricey. Those biotechs with earnings now go for 40 times the next 12 months` earnings -- or about 2.3 times the price-earnings multiple of Big Pharma stocks and the stock market generally. But the prospects of licensing deals and acquisitions could well support the prices for some time to come; it is clear from the recent deals that drug companies are willing to pay up for biotech.
Well...most of them anyway. Grumbles Robert R. Ruffolo Jr., head of Wyeth research: "These things are getting obscenely expensive." For the foreseeable future, those biotech firms with a product prospect will probably get even more obscenely expensive.
In picking possible beneficiaries, Morgan Stanley biotech analyst Steve Harr likes to focus on firms with new treatments for the toughest medical problems, like cancer. Among those firms are OSI Pharmaceuticals, Millennium Pharmaceuticals and Onyx Pharmaceuticals. (See table, Potential Deals1).


Certainly, the big drug companies have plenty of motivation to look for help: Their in-house researchers just aren`t producing enough new products. The number of new drugs launched has flattened out in recent years, in the range of 20 to 30 annually. The industry has managed to increase revenues 10% a year, nonetheless, by turning more products into blockbusters.
Some of the biggest-selling drugs will go off patent in the next couple of years, including cholesterol fighters such as Bristol-Myers` Pravachol and Merck`s Zocor. Patents expire in 2006 on Pfizer`s antidepressant Zoloft and its antibiotic Zithromax.
The wave of patent expirations will make it hard for the drug industry to continue its recent growth, said Boston Consulting Group analyst Peter Tollman, at the MIT Sloan "BioInnovations" gathering earlier this month. Tollman has studied those expirations in a drug industry model that assumes that the industry drives eight new products into blockbuster sales territory every year, as it has for a while, now. His model shows industry sales growth sliding from 10% to nearly zero, by 2007.
Drug firms are doing plenty of their own biotechnology in-house -- brewing antibodies and analyzing genetic activity. But Big Pharma also is looking to broaden its research pipeline through deals. The industry committed $25 billion to licensing pacts in 2003, compared to about $16 billion three years earlier, says Recombinant Capital. The average dollar amount committed per licensing deal rose to more than $75 million in 2003, from about $40 million in 2000.
Biotech licensing isn`t a brand new strategy for drug companies, but in the past, the big companies tended to wait until a biotech product had reached the second phase of human trials, or even the third and final phase. Each phase of testing involves more patients and more carefully designed experiments. Waiting for Phase III results was like drilling for oil in a gas station, jokes Pfizer strategist Rajiv Shukla.
There aren`t enough late-phase biotech candidates to satisfy the drug industry`s hunger, these days, so drug firms have been bidding for products in the earliest clinical trial phase -- and even in the preclinical laboratory phase.
Biotech firms with an immature product used to be happy to get a couple of million bucks up front and the promise of royalties, says Mark G. Edwards, the managing director of Recombinant Capital. Now, a growing crowd of drug-company bidders has enabled biotech firms to command up-front payments in excess of $50 million for licensing a product that is still in a Phase I clinical trial.
In September, Aventis paid $80 million to Regeneron for the rights to a Phase I product that keeps tumors from building their own blood supply (like Genentech`s recently-approved Avastin product). Aventis also bought $45 million worth of Regeneron stock, and promised hundreds of millions of dollars worth of future payments if the product reaches certain milestones.
As the drug companies place bets earlier in the testing phase -- where an average of 80% of products end up failing -- they are hedging those bets with a dizzying mix of deal terms. Edwards` consulting firm even sells software that lets bidders simulate different combinations of sales forecasts, royalty rates and profit splits.
Acquisitions are simpler to understand than licensing deals and, simply put, they`re getting bigger. While the number of biotech buyouts by drug firms has been roughly constant in the last decade -- in the range of five to 10 a year -- the price tags have climbed. Drug firms paid a total of $2.7 billion for seven biotech acquisitions in the year 2000, according to Recombinant Capital. For the six deals last year, they paid over $5 billion.
The higher stock prices of biotech stocks leave Morgan Stanley`s Harr less bullish than last year. But he still sees partnerships as clear opportunities for certain companies.


Eyetech Pharmaceuticals came public in January, raising nearly $160 million in an offering priced at $21 a share. At a recent $34, the New York-based firm has a stock market capitalization of almost $1.4 billion. That may seem like a lot for a company with one unmarketed product. But Eyetech`s Macugen is a breakthrough treatment for the eye disease known as macular degeneration. About 200,000 new cases of the disease appear each year, among aging Americans -- causing a circle of blindness right in the center of their field of vision.
Macugen blocks the cellular signal that causes overgrown blood vessels to damage the retinas of patients with the disease. In Phase III trials, the drug was about 30% more effective than a placebo at preventing vision loss. Eyetech hopes to submit its marketing application before the end of the September quarter. If approved, Macugen could be launched in early 2005 by Eyetech and marketing partner Pfizer, which ponied up $100 million in 2002 for rights in the U.S., Europe and Japan. Harr estimates that Macugen sales could approach $1 billion yearly, in 2009 -- with about two-thirds of that accruing to Eyetech. That leaves the little firm with a nice asset for either its shareholders or an acquirer. Harr puts the shares` value conservatively at $42.
Among the biotechs with promising cancer drugs, Millennium is one of the most intriguing. It had $430 million in revenue last year, with most of that from an anticlotting drug called Integrilin that is used in heart procedures. But what caused its shares to double in the last year, to a recent $17, is Velcade -- a cancer drug that the FDA approved last year for patients with advanced cases of the blood cancer known as myeloma. Johnson & Johnson has international rights to Velcade, but Cambridge, Mass.-based Millennium is busily testing the drug for use in earlier-stage myeloma, as well as a variety of other cancers. That development program will keep Millennium in the red for several more years at least, but it may also lead to other licenses.
OSI`s main hope is Tarceva, which inhibits a cancer cell growth factor in a similar way to AstraZeneca`s already-approved drug Iressa. Like the AstraZeneca drug, Tarceva seems to have a great effect in a small subset of cancer patients. OSI`s shares have doubled in the past year, and the recent price of $35 puts a $1.3 billion valuation on the Melville, N.Y., firm. With its marketing partner Roche (Genentech, in the U.S.), OSI hopes for FDA approval in 2005, to market Tarceva for patients with advanced lung cancer. But the June meeting of the American Society of Clinical Oncology will be a more decisive point for investors. Researchers will report on several Tarceva studies.
The June ASCO meeting will also provide some data on a kidney-cancer drug under development by Onyx Pharmaceuticals. In the last year, shares of the Richmond, Calif., firm have soared sixfold, to a recent 43. That enabled the company to raise $150 million in a February stock offering. Kidney-cancer patients don`t have a lot of treatment options, so Onyx and its partner Bayer hope that current Phase III trials will lead to a quick FDA approval.


AtheroGenics has no partner on its potentially big, development-phase drug for atherosclerosis. Harr believes the Atlanta-based company will have to find a partner sometime around the expected September quarter release of Phase II data on its drug. Code-named AGI-1067, the drug is designed to block the inflammation that is a major step in the clogging of arteries. If the drug works, Harr thinks AtheroGenics then could license out half of its $1 billion in annual sales. If the drug doesn`t work, then the $25 shares could go bust. The Morgan Stanley analyst owns no shares in the company, or any of the other biotechs he covers, but his firm has done investment-banking work for them all.
Biotech firms can become acquisition candidates out of weakness, as well as strength. One hedge-fund pro, who doesn`t want to be named, has become intrigued by SuperGen. The firm has done a poor job of testing its drug for a kind of bone cancer. Its stock has slid from about 13 to 8 this year, leaving the Dublin, Calif., firm with a $300 million stock market value. But clinical trials hint that SuperGen`s drug could yet prove effective, in more capable hands, says the investor.
Another interesting little biotech is Keryx Biopharmaceuticals. The New York company is conducting Phase III trials of a product that prevents kidney damage in patients with diabetes. Shares in the development stage company have risen tripled this year, to 16. But if its drug works, it will be looking to sign up a partner.
These biotech stocks, and many others, have gotten pricier in the past twelve months. But the drug industry`s quiet desperation for new products has changed the definition of "pricey."

[muycaro]

Oncolytics hat gerade seinen Jahresabschlussbericht 2003 auf seiner Webseite online gestellt (Ergebnisse wurden ja schon im März bekannt gegeben, hier jetzt das originale, ausführliche Dokument/40-F Filing) - dauert ein paar Sekunden zu laden:

http://www.integratir.com/cfiling.asp?theurl=filing%2Ephp%3F…

Ausser den finanziellen Angelegenheiten, Studienergebnissen, der üblichen Risikoauflistung, etc. beschäftigen sich auch einige Absätze mit Partnerschaftsverhandlungen und der dabei verfolgten Strategie, z.B.:


"The Company is pursuing a strategy of establishing relationships with larger companies as strategic partners. The Company intends to partner or joint venture with larger pharmaceutical companies that have existing and relevant marketing capability for its products. It is anticipated that future clinical development of the Company’s products outside Canada would generally occur in conjunction with a strategic partner or partners, who would contribute expertise and financial assistance. In exchange for certain product rights and commitments to market the Company’s products, the strategic partners would be expected to share in gross proceeds from the sale of the Company’s product or products. The proceeds generated from partnering or joint venturing projects are expected to be distributed on the basis of relative risk taken and resources contributed by each party to the partnership or joint venture."


"Product Marketing Strategy
The markets for the cancer product being developed by the Company may be large and could require substantial sales and marketing capability. Before or upon successful completion of the development of a cancer product, the Company intends to enter into one or more strategic partnerships or other collaborative arrangements with a pharmaceutical company or other company with marketing and distribution expertise to address this need. If necessary, the Company will establish arrangements with various partners for different geographical areas or specific applications. The Company’s management and consultants have relevant experience with the partnering process."

[muycaro]

Neue Zahlen zur aktuellen Shortposition aus Kanada. Diese hat sich während der letzten 14 Tage um 100k Aktien auf knapp 700.000 erhöht (in den USA dürfte es eine weitere substanzielle Short Position geben, die bei diesen Zahlen nicht mit eingeflossen ist):

Short History for ONC
Symbol Exch Report Date Volume Change
ONC T 2004-04-15 667,837 104,782
ONC T 2004-03-31 563,055 220,414
ONC T 2004-03-15 342,641 49,675
ONC T 2004-02-29 292,966 12,036
ONC T 2004-02-15 280,930 29,383
ONC T 2004-01-31 251,547 39,810
ONC T 2004-01-15 211,737 27,700
ONC T 2003-12-31 184,037 13,500

[merx]

Schönen Sonntag allerseits,

na wie wird die 18 KW werden? Der Chart von ONC hat einen
schönen Doji ausgebildet. Mir scheint als ob heimlich gesammelt wird.

http://thomson.finance.lycos.com/lycos/iwatch/cgi-
bin/iw_ticker?ticker=oncy

Gruß

merx

[muycaro]

OSI Pharmaceuticals (OSIP) ist aufgrund ermutigender Daten einer Versuchsreihe heute mit >100% oder 1,5 Milliarden Dollar Marktkapitalisierung im Plus (Genentech, die das Medikament mitentwickeln, legen derzeit sogar ca. $6 Milliarden zu).

http://biz.yahoo.com/rb/040426/markets_stocks_beforethebell_…

Das sollte dem Sektor heute Auftrieb verleihen, bzw. einige Aufmerksamkeit auf sich ziehen.
Ich bin mal gespannt was erstmal mit ONCY passiert, wenn wir weitere eigene positive Nachrichten bekommen...

Aventis hat übrigens dem verbesserten Übernahmeangebot von Sanofi Synthelabo zugestimmt. Ich lasse mich mal überraschen, was hier in nächster Zeit noch so passiert.
Ich kann mir immer noch nicht so recht einen Reim auf unseren neuen DOB, Marc Liveonen von Aventis machen.

Viel Glück Euch allen und noch einen schönen Tag.

[r.schaui]

muycaro, im board bei stockhouse wird spekuliert, ob lievonen das ende von aventis voraus gesehen hat und sich nicht zuletzt auch deshalb neu orientiert hat. Die hohen umsätze heute sind nach meiner meinung auf die ergebnisse von osip zurück zu führen.
stay long (seit synsorb) r.schaui

[muycaro]

Hi, ich glaube nicht, dass Lievonen nach einer Übernahme durch Sanofi entbehrlich wird, im Gegenteil.
Aber über das was sich genau hinter den Kulissen abspielt lässt sich eh nur spekulieren.
Zumindest habe ich mich damit abgefunden einen Vertreter der Führungsspitze eines der grössten Pharmaunternehmen der Welt in unserem Board Of Directors sitzen zu haben - gibt schlimmeres.

ONCY sieht gut aus heute, die Konsolidierung war perfekt zum nachlegen.
OSIP läuft echt stark heute - ich hoffe wir werden solche Tage demnächst auch zusammen mit ONCY erleben können. Nur nicht aus der Ruhe bringen lassen.

Viele Grüsse an alle und noch eine schöne Woche.

[Billysan]

Der gesamte Krebstherapiesektor
ist gestern enorm angesprungen:

Cell Genesis +6%
Corixa +11%
Dendreon +11%
Onyx +16%
OSIP +140%
Genta +5%

.... und wir sind auch dabei: +7% !!

|^^^^^^^^^^^^^^^|||___
|$GO ONCY$||||__,___
|_..__..___..__.===|=|__|__] ] ]
(@)`(@);;````(@)*(@)******(@)+

[muycaro]

Dieses Papier wurde für die diesjährige ASCO (American Society of Clinical Oncology) Konferenz verfasst:



"JCO Early Release, published online ahead of print Mar 29 2004
Journal of Clinical Oncology, 10.1200/JCO.2004.06.082 PDF Version of this Article
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Received June 18, 2003
Accepted December 9, 2003


Abbreviated Course of Radiation Therapy in Older Patients With Glioblastoma Multiforme: A Prospective Randomized Clinical Trial
W. Roa *, P.M.A. Brasher , G. Bauman , M. Anthes , E. Bruera , A. Chan , B. Fisher , D. Fulton , S. Gulavita , C. Hao , S. Husain , A. Murtha , K. Petruk , D. Stewart , P. Tai , R. Urtasun , J.G. Cairncross , and P. Forsyth
From the Cross Cancer Institute; Division of Epidemiology, Prevention and Screening, Alberta Cancer Board; Departments of Oncology, Laboratory Medicine and Pathology, and Surgery, University of Alberta, Edmonton; Departments of Oncology and Clinical Neurosciences, University of Calgary and Tom Baker Cancer Center, Calgary, Alberta; London Regional Cancer Center, London; Northwestern Regional Cancer Center, Thunder Bay, Ontario, Canada; and M.D. Anderson Cancer Center, Houston, TX.


* To whom correspondence should be addressed. E-mail: [e-mail]
Purpose: To prospectively compare standard radiation therapy (RT) with an abbreviated course of RT in older patients with glioblastoma multiforme (GBM).

Patients and Methods: One hundred patients with GBM, age 60 years or older, were randomly assigned after surgery to receive either standard RT (60 Gy in 30 fractions over 6 weeks) or a shorter course of RT (40 Gy in 15 fractions over 3 weeks). The primary end point was overall survival. The secondary end points were proportionate survival at 6 months (emphasis added), health-related quality of life (HRQoL), and corticosteroid requirement. HRQoL was assessed using the Karnofsky performance status (KPS) and Functional Assessment of Cancer Therapy-Brain (FACT-Br).

Results: All patients had died at the time of analysis. Overall survival times measured from randomization were similar at 5.1 months for standard RT versus 5.6 months for the shorter course (log-rank test, P = .57). The survival probabilities at 6 months were also similar at 44.7% for standard RT versus 41.7% for the shorter course (lower-bound 95% CI, -13.7). KPS scores varied markedly but were not significantly different between the two groups (Wilcoxon test, P = .63). Low completion rates of the FACT-Br (45%) precluded meaningful comparisons between the two groups. Of patients completing RT as planned, 49% of patients (standard RT) versus 23% required an increase in posttreatment corticosteroid dosage (2 test, P = .02).

Conclusion: There is no difference in survival between patients receiving standard RT or short-course RT. In view of the similar KPS scores, decreased increment in corticosteroid requirement, and reduced treatment time, the abbreviated course of RT seems to be a reasonable treatment option for older patients with GBM."

http://www.jco.org/cgi/content/abstract/JCO.2004.06.082v1" target="_blank" rel="nofollow ugc noopener">http://www.jco.org/cgi/content/abstract/JCO.2004.06.082v1


_____________________



Der Studie nach(man beachte, dass Dr. Forsyth hier involviert war) verstarben alle an Glioblastoma Multiforme (aggressivster Gehirntumor) leidenden Patienten noch vor der 6 monatigen Beobachtungsfrist.

Aussagen von Oncolytics zufolge waren einige der Gliblastoma Patienten, die damals mit Reolysin behandelt wurden (suboptimale Dosis), jedoch offensichtlich noch nach deutlich über einem Jahr(!) am Leben:


http://www.oncyedu.info/Glioblastoma.html

Anecdotal and reported glio results (still being tested and awaiting formal results any day now)

As of today, the three patients still alive when Brad last mentioned them on Oct 22, 2003, will be at 17.3, 17.9, and 19.8 months since their injection.

We do not know if they are still alive, and actually don`t need to know at this point, as a doubling of lifespan to six months (rather than the three or fewer months expected) is a dramatic improvement in itself, and tells us almost everything that we need to know.

Beyond this; the patients enrolled in this Trial surely had more problems than “just” brain cancer following their earlier chemo and surgeries; they received a sub-optimal dose (maximum dose = one “mouse size” dose); received only a single treatment; and received that treatment as an injection with all the limitations that injection brings that could block the REOLYSIN from moving freely through the tumor area.

For those that don`t have the information (published and anecdotal) that has been seen on this board:

One patient died at 2.3 months after injection. Apparently his condition had improved so dramatically, that he stopped taking his anti-seizure medication that had been prescribed after his earlier surgeries. He died during a subsequent seizure. No serious adverse events were attributed to the administration of REOLYSIN and no dose-limiting toxicity was reached.

One patient died at 3.3 months after injection. As this is about the expected lifespan pre-injection, we might be seeing a case where the tumor was not Ras-active (about 10% of brain tumors aren`t Ras-active). No serious adverse events were attributed to the administration of REOLYSIN and no dose-limiting toxicity was reached.

One patient died at 9.7 months after injection. That patient`s condition improved before deteriorating. No serious adverse events were attributed to the administration of REOLYSIN and no dose-limiting toxicity was reached.

Oct 22, 2003, the remaining 3 patients were alive, and had survived 12.9, 13.5, and 15.4 months at that time. These 3 patients have not been observed to display any serious adverse events due to the administration of REOLYSIN, and no dose-limiting toxicity had been observed to date.

[muycaro]

Noch ein interessanter Beitrag aus dem stockhouse Forum (man sieht da schon einige Parallelen, wenn man sich ONCYs `low key` PR Arbeit ins Gedächtnis ruft):



SUBJECT: Presentation - Dr. Noujaim Posted By: biotechvestor
Post Time: 4/26/04 21:57
« Previous Message Next Message »

I attended a presentation today hosted at the U of A by Dr. Antoine Noujaim who as you
may know is on the board of Oncolytics. It was very interesting in that he was talking
about the mix of business people and scientists in biotech and the development and
commercialization of drugs. He had a couple of main points. The first was that in biotech
he feels that it is essential for companies to suppress news about their products as long as
possible, even to the point when they reach approval. Dr. Noujaim thought this was
important because a drug is “proven” to work before it is marketed.
His second main contention was that, scientists attend conferences and share information
with other scientists regarding their research and this is detrimental to the development of
biotech. He joked that “scientists should never talk too loudly in bars about their
discoveries because ‘you never know who is listening in.’”

Unlike scientists, business people he argued, are far more cautious in who they share
information with and are necessary to complement the work of scientists, especially in
terms of protecting intellectual property and overseeing the commercialization of a
product.

It seems to me that Oncolytics has remarkable similarities to the points made by Dr.
Noujaim. The points he brought forth made a great deal of sense and are similar to the
way Oncolytics conducts business in that there is no considerable effort to “market” its
potential to investors.

Perhaps this provides a justification for why we have not seen an extensive investor
relations effort by Oncolytics.

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http://www.stockhouse.ca/bullboards/viewmessage.asp?no=78011…

[marvessa]

wie hiess die Fa. früher ??? oder war hier mal ne Übernahme oder ähnliches ?

[muycaro]

Das Unternehmen heisst seit seiner Gründung 1998 Oncolytics Biotech. Hier ein kleines Firmenprofil:

http://www.integratir.com/primarymessage.asp?ticker=t.onc

[merx]

eventuelle Scenariobeschreibung aus dem Yahoo-Board


ONCY Investors Guide
by: cfinvestor
Long-Term Sentiment: Strong Buy 04/28/04 12:39 pm
Msg: 17322 of 17328

Biotechnology investing, like clinical trials, has three stages:
Phase I is the "high-risk/high-rewards" stage consisting of "small" money (between $10M and $100M) coming from venture capital funds, wealthy individuals, and some brave common share buyers. Phase I for ONCY ended shortly after the NCI agreement.
Phase II begins, usually, with such news as the NCI pact and an additional private placement to raise working capital. The clearest signal of all, however, was the sudden increase of the pps several weeks ago. Now, the "middle money" has arrived--those who will risk losses of between $100M and $500M "trading" ONCY shares. The current volatility is clear evidence that ONCY has attracted serious wall street interest. The ONCY story is a good one and will ultimately carry the pps much higher (its the "story" not the science for these traders).
Modest accumulation on dips is a fairly safe strategy during this period, but be prepared for brutual take-downs to shake weak hands and induce margin calls. ONCY will be in Phase II for at least 12 to 18 months. A significant pps increase can occur, but it is not guaranteed!
Phase III is the big money stage when only the $1 billion+ investors take over. Shorts are wiped out (assuming success), weak hands are gone, hedge funds are off to other prey, and long-term investors are rewarded.
For those who are concerned with current conditions of bashings, price volatility, etc. , please remember it goes with the territory. Phae II is no fun, but it can be rewarding (speaking as a ONXX vet).

[marvessa]

wurde mal irgendwer übernommen und dafür mit Oncolytics
Aktien bezahlt ???

ich habe welche im Depot und weiss nicht mehr warum !!!
gekauft hab ich sie auf jeden Fall nie

[r.schaui]

Marvessa, synsorb hatte anteile an oncolytics und nachdem die ihr eigenes programm mangels erfolg eingestellt hatten wurden die anteile an oncolytics an die aktionäre übertragen.
mfg r.schaui

[r.schaui]

marvessa, im Juni 2002 gab es für eine synsorb Aktie
0,100812 oncolytics.
dein depot muss gut bestückt sein, dass du jetzt erst merkst, dass du oncolytics hast
nichts für ungut r.schaui

[muycaro]

Die nächste Konferenz (13.05.2004) auf der Oncolytics vertreten ist:

5/13/2004 - BioFinance 2004
Dr. Matt Coffey, VP of Product Development for Oncolytics will present a corporate overview at BioFinance 2004 on May 13, 2004 in Toronto, Ontario

Link on ONC website:
http://www.integratir.com/calendar.asp?ticker=t.onc

BioFiance website:
http://www.biofinance.ca/main.cfm?docID=1

[muycaro]

Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Inc. Announces 2004 First Quarter Results
Monday May 3, 8:31 am ET


CALGARY, May 3 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX: ONC, NASDAQ: ONCY) today announced its financial results for the three-month period ending March 31, 2004.
First Quarter Highlights:

- Received approval to commence a Phase I systemic (intravenous)
administration clinical trial at the Royal Marsden Hospital, Surrey,
U.K.
- Provided a final update on the T2 prostate cancer clinical trial
- Strengthened the Board of Directors with the addition of Mr. Jim
Dinning
- Added an 11th U.S. patent covering manufacturing of REOLYSIN(R)
- Announced a $6.73 million private placement with a European
institutional investor


"During the quarter, we made a number of significant advancements in the development of REOLYSIN® as a potential cancer therapeutic," said Dr. Brad Thompson, President and CEO of Oncolytics.

MANAGEMENT`S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS


This discussion and analysis should be read in conjunction with the unaudited financial statements of Oncolytics Biotech Inc. ("Oncolytics" or the "Company") as at and for the three months ended March 31, 2004 and 2003, and should also be read in conjunction with the audited financial statements and Management`s Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") contained in Oncolytics` annual report for the year ended December 31, 2003. The financial statements have been prepared in accordance with Canadian generally accepted accounting principles ("GAAP").

FORWARD-LOOKING STATEMENTS

The following discussion contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company`s belief as to the potential of REOLYSIN® as a cancer therapeutic, the Company`s expectation regarding the adequacy of its existing capital resources, and the Company`s expectations as to the success of its research and development programs in 2004 and beyond, future financial position, business strategy and plans for future operations, and statements that are not historical facts, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, the Company`s ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals, uncertainties related to competition, changes in technology, the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Forward-looking statements are based on assumptions, projections, estimates and expectations of management at the time such forward-looking statements are made, and such assumptions, projections, estimates and/or expectations could change or prove to be incorrect or inaccurate. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements.

OVERVIEW

Oncolytics Biotech Inc. is a Development Stage Company


Since its inception in April of 1998, Oncolytics Biotech Inc. (the "Company") has been a development stage company and has focused its research and development efforts on the development of REOLYSIN®, its potential cancer therapeutic. The Company has not been profitable since its inception and expects to continue to incur substantial losses from its research and development. The Company does not expect to generate significant revenues until, if and when, its cancer product becomes commercially viable.

General Risk Factors

Prospects for biotechnology companies in the research and development stage should generally be regarded as speculative. It is not possible to predict, based upon studies in animals, or early studies in humans, whether a new therapeutic will ultimately prove to be safe and effective in humans, or whether necessary and sufficient data can be developed through the clinical trial process to support a successful product application and approval.

If a product is approved for sale, product manufacturing at a commercial scale and significant sales to end users at a commercially reasonable price may not be successful. There can be no assurance that the Company will generate adequate funds to continue development, or will ever achieve significant revenues or profitable operations. Many factors (e.g. competition, patent protection, appropriate regulatory approvals) can influence the revenue and product profitability potential.

In developing a product for approval, the Company will rely upon its employees, contractors, consultants and collaborators and other third party relationships, including the ability to obtain appropriate product liability insurance. There can be no assurance that these reliances and relationships will continue as required. In addition to developmental and operational considerations, market prices for securities of biotechnology companies generally are volatile, and may or may not move in a manner consistent with the progress being made by the Company.

Highlights

During the first quarter of 2004, the Company`s net loss was $2,676,236 compared to $1,114,314 for the first quarter of 2003. The increase in the net loss primarily reflects the increased manufacturing costs incurred by the Company in preparation for its planned clinical trial program and other supporting activities. Also, the Company took action to further diminish its economic dependence related to having only one manufacturer of REOLYSIN® by entering into a manufacturing contract with a second supplier and incurred costs in the quarter associated with the transfer of its manufacturing process to the additional supplier. In addition, the Company`s clinical trial, pre-clinical trial, and research collaboration expenses increased compared to the first quarter of 2003.

Recent Developments

On April 7, 2004, the Company sold 1,077,100 units, pursuant to a private placement, at an average price of $6.25 per unit. Net cash proceeds after issue costs were approximately $6,206,875. The units are comprised of 1,077,100 common shares and 538,550 common share purchase warrants. Each whole common share purchase warrant entitles the holder to acquire one common share of the capital of the Company upon payment of $7.75 per share until October 7, 2005. In addition, the Company issued 107,710 common share purchase warrants to its adviser entitling the holder to acquire one common share of the capital of the Company upon payment of $7.00 per share until October 7, 2005. The Company will use the proceeds from this financing for general corporate purposes.

RESULTS OF OPERATIONS

Net loss for the three month period ended March 31, 2004 was $2,676,236 compared to $1,114,314 for 2003. The increase in the Company`s net loss was due to the following:

Research and Development Expenses ("R&D")

2004 2003
$ $
-------------------------------------------------------------------------
Manufacturing and process expenses 1,376,430 66,108
Clinical trial expenses 125,645 10,643
Pre-clinical trial and research collaboration
expenses 178,960 57,826
Other R&D expenses 273,362 345,058
-------------------------------------------------------------------------
Research and development expenses 1,954,397 479,635
-------------------------------------------------------------------------
-------------------------------------------------------------------------


For the first quarter of 2004, R&D increased to $1,954,397 compared to $479,635 for the first quarter of 2003. The increase in R&D was due to the following:

Manufacturing & Related Process Development

During the first quarter of 2004, the Company continued to focus on the production of REOLYSIN® in order to supply its R&D activity. Approximately 75% of the manufacturing and process development costs incurred in the first quarter of 2004 relate to the production of REOLYSIN® compared to nil in the first quarter of 2003. The increase in production costs also relates to technology transfer and set up costs associated with the addition of a second supplier in the first quarter of 2004.

The majority of the remaining costs incurred in the first quarter of 2004 and all of the costs incurred in the first quarter of 2003 relate to process development expenses. The increase in process development expenses is due to the continued development of the Company`s viral and cell banks which did not occur in 2003.

For the remainder of 2004, the Company expects that it will continue to produce REOLYSIN® and that a majority of these costs will relate directly to manufacturing.

Clinical Trial Programs

The Company`s clinical trial expenses increased to $125,645 in the first quarter of 2004 compared to $10,643 for the first quarter of 2003. The increase was primarily due to the costs incurred in obtaining the approval to commence a systemic (intravenous) delivery clinical trial in the United Kingdom and continuing enrollment in its recurrent malignant glioma brain cancer study.

Pre-Clinical Trial and Research Collaboration Expenses

During the first quarter of 2004, the Company incurred increased pre-clinical and research collaboration expense that may assist in future clinical trial applications.

Operating Expenses

2004 2003
$ $
-------------------------------------------------------------------------
Salary, insurance and other office expenses 378,417 215,279
Public company and other operating expenses 322,757 306,275
Stock based compensation 5,426 471
-------------------------------------------------------------------------
706,600 522,025
-------------------------------------------------------------------------
-------------------------------------------------------------------------


For the first quarter of 2004, the Company`s operating expenses increased to $706,600 compared to $522,025 for the first quarter of 2003. Specifically, the Company incurred additional salary and insurance costs in the first quarter of 2004 compared to the first quarter of 2003. The increase in salary costs relates to additional staff levels that occurred in the second quarter of 2003 primarily in support of its corporate requirements including those associated with public company requirements. The increase in insurance premiums relates to the increased premiums for Directors` and Officers` liability insurance that began in the second quarter of 2003.

Sale of Investments
2004 2003
$ $
-------------------------------------------------------------------------
Gain on sale of investment in
BCY LifeSciences Inc. ("BCY") 47,648 -
-------------------------------------------------------------------------
-------------------------------------------------------------------------


In the first quarter of 2004, the Company sold 676,945 common shares of BCY for net cash proceeds of $131,650. This resulted in an accounting gain of $47,648. As at March 31, 2004, the Company owned 221,000 common shares and 694,995 common share purchase warrants of BCY. The common share purchase warrants were exercisable at $0.27 and expired out of the money on April 23, 2004.

Commitments

As at March 31, 2004, the Company has committed to payments totaling $1,704,102 for activities primarily related to product manufacturing and continued toxicology and process related work. The Company anticipates that these committed payments will occur in 2004. All of these committed payments are considered to be part of the Company`s normal course of business.

LIQUIDITY AND CAPITAL RESOURCES

Liquidity


As at March 31, 2004, the Company had cash and cash equivalents, short-term investments and working capital positions of $2,941,266, $17,356,874 and $18,493,690 respectively compared to $2,641,127, $18,111,608 and $20,088,868 as at December 31, 2003. The decrease in the first quarter of 2004 reflects the operating and investing activities of the Company offset by the cash received from the exercise of warrants and options. For the three month period ended March 31, 2004, the Company had received proceeds from the exercise of warrants and options of $944,745. Cash outflows during the first quarter of 2004 were due to research and development expenses, operational expenses, and intellectual property expenditures.

The Company desires to maintain adequate cash and short-term investment reserves to support its planned activities which include its clinical trial program, production manufacturing, and its intellectual property expansion and protection as well as administrative activities. The Company believes that its existing capital resources, including the recently closed private placement (see "Recent Developments") are adequate to fund its current plans for research and development activities through 2006 without presuming the further exercise of outstanding warrants and options. In the event that the Company chooses to seek additional capital, the Company will look to fund additional capital requirements primarily through the issue of additional equity. The Company recognizes the challenges and uncertainty inherent in the capital markets and the potential difficulties it might face in today`s environment. Market prices for securities in biotechnology companies are volatile and the ability to raise funds will be dependent on a number of factors, including the progress of R&D, availability of clinical trial information, and general market conditions.

Capital Expenditures and Commitments

During the first quarter of 2004 the Company spent $130,540 on intellectual property compared to $459,660 in the first quarter of 2003. The difference relates to variances in filing fees on existing patent applications.

Investing Activities

Under its Investment Policy, the Company is permitted to invest in short-term instruments with a rating no less than R-1 (DBRS) with terms less than two years. As at March 31, 2004, the Company invested $17,356,874 under this policy and is currently earning interest at an effective rate of 2.67%.

OTHER MD&A REQUIREMENTS

The Company has 29,010,171 common shares outstanding at April 29, 2004. If all of the Company`s warrants and options were exercised the Company would have 35,090,577 common shares outstanding.

Oncolytics Biotech Inc.

BALANCE SHEETS


As at,
March 31, December 31,
2004 2003
$ $
(unaudited) (audited)
---------------------------
ASSETS
Current
Cash and cash equivalents 2,941,266 2,641,127
Short-term investments 17,356,874 18,111,608
Accounts receivable 62,305 64,224
Prepaid expenses 129,102 156,837
---------------------------
20,489,547 20,973,796
Capital assets

Investments (note 3) 4,918,494 4,965,379
27,423 111,425
---------------------------
25,435,464 26,050,600
---------------------------
---------------------------
LIABILITIES AND SHAREHOLDERS` EQUITY
Current
Accounts payable and accrued liabilities 1,995,857 884,928
---------------------------
Alberta Heritage Foundation loan 150,000 150,000
---------------------------

Shareholders` equity
Share capital (note 2)
Authorized: unlimited
Issued: 27,450,389 (2003 - 27,208,262) 45,765,630 44,712,589
Warrants (note 2) 1,489,954 1,598,250
Contributed surplus 3,704,851 3,699,425
Deficit (27,670,828) (24,994,592)
---------------------------
23,289,607 25,015,672
---------------------------

25,435,464 26,050,600
---------------------------
---------------------------
See accompanying notes




Oncolytics Biotech Inc.

STATEMENTS OF LOSS AND DEFICIT


For the three month periods ended March 31,
Cumulative
from inception
on April 2,
1998 to March
2004 2003 31, 2004
$ $ $
(unaudited) (unaudited) (unaudited)
---------------------------------------------
Revenue
Rights revenue - - 310,000
Interest income 117,356 43,170 2,203,339
---------------------------------------------
117,356 43,170 2,513,339
---------------------------------------------
Expenses
Research and development 1,954,397 479,635 18,845,466
Operating 706,600 522,025 8,467,513
Amortization 179,023 155,224 2,089,113
---------------------------------------------
2,840,020 1,156,884 29,402,092
---------------------------------------------

Loss before the following: 2,722,664 1,113,714 26,888,753

Gain on sale of BCY
LifeSciences Inc. (note 3) (47,648) - (312,101)

Loss on sale of Transition
Therapeutics Inc. - - 2,156,685
---------------------------------------------

Loss before taxes 2,675,016 1,113,714 28,733,337

Capital tax 1,220 600 52,491

Future income tax recovery - - (1,115,000)
---------------------------------------------

Net loss for the period 2,676,236 1,114,314 27,670,828

Deficit, beginning of period 24,994,592 16,450,561 -
---------------------------------------------

Deficit, end of period 27,670,828 17,564,875 27,670,828
---------------------------------------------
---------------------------------------------
Basic and diluted loss
per share 0.10 0.05
-------------------------------
-------------------------------
Weighted average number
of shares 27,255,740 22,221,506
-------------------------------
-------------------------------
See accompanying notes



Oncolytics Biotech Inc.


STATEMENTS OF CASH FLOWS


For the three month periods ended March 31,
Cumulative
from inception
on April 2,
1998 to March
2004 2003 31, 2004
$ $ $
(unaudited) (unaudited) (unaudited)
---------------------------------------------

OPERATING ACTIVITIES
Net loss for the period (2,676,236) (1,114,314) (27,670,828)
Deduct non-cash items
Amortization 179,023 155,224 2,089,113
Non-cash compensation 5,426 471 1,034,851
Gain on sale of
BCY LifeSciences Inc. (47,648) - (312,101)
Loss on sale of
Transition Therapeutics Inc. - - 2,156,685
Future income tax recovery - - (1,115,000)
Net changes in non-cash
working capital 1,140,583 (257,136) 1,719,783
---------------------------------------------
(1,398,852) (1,215,755) (22,097,497)
---------------------------------------------

INVESTING ACTIVITIES
Intellectual property (130,540) (459,660) (2,795,366)
Other capital assets (1,598) (622) (512,570)
Purchase of short-term
investments (245,266) - (18,356,874)
Redemption of short-term
investments 1,000,000 - 1,000,000
Investment in
BCY LifeSciences Inc. 131,650 - 454,678
Investment in
Transition Therapeutics Inc. - - 2,532,343
---------------------------------------------
754,246 (460,282) (17,677,789)
---------------------------------------------

FINANCING ACTIVITIES
Alberta Heritage
Foundation loan - - 150,000
Proceeds from exercise of
warrants and stock options 944,745 - 4,405,730
Proceeds from private
placements - 244,171 16,518,220
Proceeds from public
offerings - - 21,642,602
---------------------------------------------
944,745 244,171 42,716,552
---------------------------------------------
Increase (decrease) in
cash and cash equivalents
during the period 300,139 (1,431,866) 2,941,266
Cash and cash equivalents,
beginning of the period 2,641,127 8,319,244 -
---------------------------------------------
Cash and cash equivalents,
end of the period 2,941,266 6,887,378 2,941,266
---------------------------------------------
---------------------------------------------
See accompanying notes



Oncolytics Biotech Inc.

NOTES TO FINANCIAL STATEMENTS

March 31, 2004 and 2003 (unaudited)


1. ACCOUNTING POLICIES

These unaudited interim financial statements do not include all of the
disclosures included in the Company`s annual financial statements.
Accordingly, these unaudited interim financial statements should be read
in conjunction with the Company`s most recent annual financial
statements. The information for the year ended December 31, 2003 has been
derived from the Company`s audited financial statements for the year then
ended.

The accounting policies used in the preparation of these unaudited
interim financial statements conform with those used in the Company`s
most recent annual financial statements.


2. SHARE CAPITAL

Authorized:

Unlimited number of common shares
Issued: Shares Warrants
-------------------------------------------------------------------------
Number Amount $ Number Amount $
-------------------------------------------------------------------------

Balance,
December 31, 2002 22,145,284 30,191,572 550,000 114,286

Issued for cash pursuant
to February 10, 2003
private placement 140,000 265,540 77,000 16,000

Issued for cash pursuant
to June 19, 2003
private placement 2,120,000 5,912,113 1,272,000 543,287

Issued for cash pursuant
to August 21, 2003
private placement 1,363,900 3,801,778 813,533 349,176

Issued for cash pursuant
to October 14, 2003
public offering 1,200,000 5,528,972 720,000 617,428

Exercise of options 64,700 149,615 - -

Exercise of warrants 174,378 593,194 (174,378) (41,927)

Share issue costs - (1,730,195) - -
-------------------------------------------------------------------------
Balance,
December 31, 2003 27,208,262 44,712,589 3,258,155 1,598,250

Exercise of warrants 235,377 1,038,228 (235,377) (108,296)

Exercise of options 6,750 14,813 - -
-------------------------------------------------------------------------
Balance,
March 31, 2004 27,450,389 45,765,630 3,022,778 1,489,954
-------------------------------------------------------------------------
-------------------------------------------------------------------------

The following table summarizes the Company`s outstanding warrants as at
March 31, 2004:

Weighted
Average
Remaining
Outstanding, Granted Exercised Outstanding, Contractual
Exercise Beginning of During During End Life
Price the Period the Period the Period of Period (years)
-------------------------------------------------------------------------

$3.00 480,755 - (99,259) 381,496 0.19
$4.00 2,057,400 - (85,934) 1,971,466 0.79
$5.00 120,000 - (20,184) 99,816 1.04
$6.25 600,000 - (30,000) 570,000 1.04
---------------------------------------------------------------
3,258,155 - (235,377) 3,022,778 0.76
---------------------------------------------------------------
---------------------------------------------------------------

Stock Option Plan

The Company has issued stock options to acquire common stock through its
stock option plan of which the following are outstanding at:

March 31, 2004 December 31, 2003
-----------------------------------------------
Weighted Weighted
Average Average
Stock Share Stock Share
Options Price $ Options Price $
-----------------------------------------------

Outstanding at
beginning of period 2,800,800 3.87 2,653,500 4.40
Granted during period - - 599,000 3.71
Cancelled during period - - (387,000) 7.97
Exercised during period (6,750) 2.19 (64,700) 2.31
----------- -----------
Outstanding
at end of period 2,794,050 3.81 2,800,800 3.81
----------- -----------
----------- -----------
Options exercisable
at end of period 2,713,633 3.87 2,720,383 3.87
----------- -----------
----------- -----------

As the Company is following the fair value based method of accounting for
employee options, compensation expense of $5,426 (March 31, 2003 - nil)
has been recorded for the period with respect to the vesting of employee
options issued in prior periods with an offsetting credit to contributed
surplus.


3. INVESTMENTS

During the three month period ending March 31, 2004, the Company sold
676,945 of its BCY shares for net cash proceeds of $131,650 recording a
gain on sale of investment of $47,648. As at March 31, 2004, the
Company`s remaining ownership in BCY was 221,000 common shares with a
book value of $27,423 and an estimated market value of $41,990 based on
the trading price at March 31, 2004.


4. SUBSEQUENT EVENT

On April 7, 2004, the Company sold 1,077,100 units, pursuant to a private
placement, at an average price of $6.25 per unit. Net cash proceeds after
share issue costs, including the fees paid to its advisor, were
approximately $6,206,875. The units are comprised of 1,077,100 common
shares and 538,550 common share purchase warrants. Each whole common
share purchase warrant entitles the holder to acquire one common share of
the capital of the Company upon payment of $7.75 per share until
October 7, 2005. In addition, the Company issued 107,710 common share
purchase warrants to its adviser entitling the holder to acquire one
common share of the capital of the Company upon payment of $7.00 per
share until October 7, 2005.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/prnews/040503/to103_1.html

[muycaro]

Aus dem Calgary Herald (kanadische Tageszeitung) von heute:

The grants announced Tuesday by the Canadian Cancer Society,will aid research in cancer genetics,anti-cancer drug therapy and oncolytic viruses(the use of viruses to kill cancer cells).
Dr.Donald Morris of the Tom Baker Cancer Centre in Calgary has been awarded $309,000 over three years to determine if a common and relatively harmless virus called reovirus can be used to improve bone marrow transplant therapy for cancer patients.
Morris said the reovirus,a common and relatively harmless virus,has shown promising cancer-fighting potential in recent studies.
"It`s a common environmental virus which has had a real selectivity to kill cancer cells and leave normal cells alone,"said Morris.
Morris is investigating ways the reovirus could improve bone marrow transplantation treatment for blood cancer patients.He`s hoping to use the reovirus to wipe out cancer cells in bone marrow taken from patients before their chemotherapy treatment.Transplanting cancer-free marrow back into these patients will greatly improve their chances of remaining cancer free.
Blood cell cancers like lymphoma,leukemia and myeloma kill more than 60,000 people in North America every year.One treatment that has improved the survival rates for these cancers is the use of high doses of chemotherapy(anti-cancer drugs).
But high-dose chemotherapy destroys not only cancer cells but also the cells in the bone marrow that eventually become blood cells.To avoid this,patients have bone marrow cells removed before chemotherapy,then put back in afterwards.However,the collected bone marrow cells often contain cancer cells that could cause the patient`s cancer to return if they were put back in the body.
Morris`s team is studying a way to destroy cancer cells in collected bone marrow,which could significantly improve the survival rates of patients with blood cancers.
Taken from the Calgary Herald Wednesday May 5,2004 on page B7 of the City & Region section.

[muycaro]

Aktuelle Short Position in Kanada (ohne die Aktien die an der Nasdaq Short sind):

Short History for ONC
Symbol Exch Report Date Volume Change
ONC T 2004-04-30 625,937 -41,900
ONC T 2004-04-15 667,837 104,782
ONC T 2004-03-31 563,055 220,414
ONC T 2004-03-15 342,641 49,675
ONC T 2004-02-29 292,966 12,036
ONC T 2004-02-15 280,930 29,383
ONC T 2004-01-31 251,547 39,810
ONC T 2004-01-15 211,737 27,700
ONC T 2003-12-31 184,037 13,500

-41,9K auf 626K Aktien gefallen.
Schätze mal in den USA sollten noch ca. 150-400K Aktien short sein, also insgesamt ca. 800K bis 1M Aktien an beiden Handelsplätzen zusammen.

Vielleicht gibt es vor der AGM (Hauptversammlung) noch News, die zu einem Squeeze führen, mal sehen.
Warte immer noch auf den Start der Versuchsreihen im Royal Marsden Hospital, London, die Bekanntgabe der NCI gesponsorten Trials und Ergebnisse aus den klinischen Versuchen bezüglich Glioblastoma (aggressivste Gehirntumore), weitere Patente, etc.

[muycaro]

Achso, I-Watch hat die letzten Tage einige institutionelle Aktivitäten signalisiert, aber seht selbst:





http://thomson.finance.lycos.com/lycos/iwatch/cgi-bin/iw_tic…

[muycaro]

Morgen findet die jaehrliche Hauptversammlung von Oncolytics statt. Ich bin leider verhindert, da auf Reisen, erste Berichte von Teilnehmern sollte es morgen Nacht, bzw. uebermorgen frueh geben (siehe Yahoo und Stockhouse Board).

Viele Gruesse an alle und cheers auf hoffentlich gute News!

[merx]

Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Starts Patient Treatment in UK Phase I Cancer Trial Investigating Systemic Delivery of REOLYSIN(R)
Wednesday May 26, 4:10 pm ET


CALGARY, May 26 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that it has started patient treatment in its UK Phase I clinical trial investigating the systemic delivery of REOLYSIN® as a treatment for patients with advanced or metastatic solid tumours.
ADVERTISEMENT


This clinical trial is an open-label, dose-escalation Phase I study in which REOLYSIN® will be administered intravenously to patients diagnosed with advanced or metastatic solid tumours that are refractory to standard therapy (have not responded) or for which no curative standard therapy exists. The primary objective of the study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT) and safety profile of REOLYSIN®. Secondary objectives include the evaluation of viral replication, immune response to the virus and any evidence of antitumour activity. The enrolment in this study is expected to be up to forty evaluable patients and will depend upon the number of dose levels tested. The principal investigator for the study is Dr. J. de Bono of the Royal Marsden Hospital.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company`s expectations related to the results of the UK Phase I trial investigating systemic delivery of REOLYSIN® and the Company`s belief as to the potential of REOLYSIN® as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, the Company`s ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

That is fine...........

m e r x

[muycaro]

Darauf haben wir lange gewartet, endlich fangen die Versuchsreihen inklusive intravenoeser Verabreichung von Reolysin im Royal Marsden Hospital in London statt.
Mal sehen, was spaeter am Tage noch so von der Hauptversammlung berichtet wird.

Viele Gruesse, muycaro

[muycaro]

Hier die Abschrift der Hauptversammlung. Da hat sich jemand viel Muehe gemacht (den originalen Audiostream dazu gibt es auch nochmal auf der Oncolytics Webseite):

http://www.stockhouse.ca/bullboards/viewmessage.asp?no=79519…

SUBJECT: AGM transcript Posted By: Reovirus1
Post Time: 5/27/04 18:14
« Previous Message Next Message »

Here it is. I`ve done my best to transcribe it correctly. Of course there will be some minor errors, especially punctuation but I think that otherwise its pretty good.
Wade.


Before we begin the presentation, I’d like to draw your attention to forward looking statements. We trade on the NASDAQ, we’re compelled by securities law to draw your attention to forward looking statements and we’d like to draw your attention to our more recent US filings as well.

Today I’d like to do a number of things, I’ve actually done introductions already as part of the formal meeting so I’ll dispense with that. But our directors and officers and actually the rest of our staff are all here today to discuss with you afterwards if you’d like on a one to one basis anything you’d like to talk about. From that I’d like to go into a quick summary of what we consider to be our highlights and review and then specifically go through the development program with respect to Reolysin. And that would include comments with respect to our clinical program and we had some interesting news today which we’d like to share with you, Our development program which is leading to new clinical study, our intellectual property and manufacturing. I’d like to do a financial update to tell you the financial status of the company and to give you some idea of what are expectations are looking ahead.

Well and this has not been changed since two/ten when we announced but we had approval this year of our first systemic administration study. And that was at the Royal Marsden Hospital in the UK. And we announced earlier today that we actually treated our first patient which was very satisfying for us. We concluded a clinical trial agreement (??) I’ll be going into a lot more detail about where that is and where that’s going. We concluded our T2 prostate cancer study and I’ll be discussing the results of that. We continued enrolment in our Canadian-based glio-blastoma multiforma clinical study. We established a very robust and important advisory board to help oversee and direct what we do. We’ve greatly expanded our IP base with the issuance of five US patents. Something that’s extremely important is actually manufacturing our first clinical log under GMP manufacturing practises of Reolysin. This was material that was actually shipped to the UK and used to treat the treatment that was enrolled with our new production process which we announced last year. And we greatly strengthened our financial reserves for reasons which I will tell you about.

Our corporate focus now is solely on Oncology. In the past we had had some motion or movement into other areas. But in the last year we decided as a corporate strategy to focus strictly on Oncology and that is all we do today. And very specifically within that corporate focus is a very specific technical focus and that is looking at what we call RAS active oncolytic viruses. The RAS pathway of which you’ve heard us speak of many times now I imagine is a very important target in oncology with respect to dealing with cancer today. And we have a very active interest in RAS active oncolytic viruses which are viruses which exploit the RAS pathway to grow in and kill cancer. And our lead product which I will focus virtually all my time and attention on is Reolysin.

(cell phone ringing) That’s not in my head, I’m glad (laughter).

Our business is really a convergence of a number of areas, some of which you see and some of which you don’t see day to day. There really is a great deal of focus on science, what we call mechanism of action, and I’ll be giving an update on some of the areas we are working on in there. That overlaps, and it’s a very important overlapping with very specific business strategy and clinical strategy. And if all three of these areas don’t converge in just the right way, and all the elements don’t come together in the right way, at the end of the day we won’t have a product that’s registered and for sale. So today I’d like to address all these elements underneath this. Its very important to understand that a program isn’t just manufacturing, its just not IP, its just not clinical studies, it’s a number of things that have to come together to make that all occur.

Well what is Reolysin? Reolysin is based on a virus whose activity was discovered here locally at the university of Calgary. And it’s a naturally occurring virus called the Reovirus. Reo stands for Respiratory Enteric Orphan virus. And its thought that the virus naturally grows in the lining of your lungs and your bowels in the fast growing cells that live there. And its shed and spread through fecal oral transmission primarily.

The virus we’re using or the type of virus we’re using of Reovirus is a naturally occurring form, its not genetically engineered, its not specifically adapted, its not altered in anyway, its simply a very specific type, type 3 of the Reovirus. Its also what’s called a replication competent virus which means it replicates freely as it would normally in the environment in cancer cells. That’s very important for us with respect to being able to actually make it in a manufacturing mode.

The virus is thought to be primarily asymptomatic in its normal mode in humans. About 50% of children by age 12 show evidence of infection of the virus anywhere you go and anywhere between 70 and 100% of adults. It’s a very common environmental virus. Its thought and has proven to be quite safe.

The virus doesn’t select cancer based on the outside of the cell. Some cancer cells have differences on the outside, they have tumour specific antigens and such on the outside. This virus doesn’t determine that. It enters every cell in your body without discrimination. It will enter a healthy cell or a cancer cell.


Its what happens on the inside that determines whether this virus actually will reproduce and kill that cell or not. What happens inside a normal cell, is that it doesn’t find the environment, the metabolic environment that’s required to replicate and the cell actually actively shuts down growth and replication of the virus. In a RAS activated cancer cell specifically, that specific metabolic environment exists and the anti-viral mechanisms of the cell are actually shut down. That allows the virus to replicate and grow and it will produce progeny virus up to 20,000 variants per cell and then it spreads through other tissues as you saw in the animations prior to the business part of this meeting.

How common is RAS and where is it found? RAS the protein is a protein on the cell signalling pathway that your cell uses to divide. Cells don’t divide by themselves. They have to be told to divide. The signal that will come to the outside of the cell that says divide. That signal is passed on down this chain into the nucleus of the cell and on that chain is this thing called RAS. Now if you do a mutation at RAS or a change at RAS, that could turn that pathway on full time. But if you do a change or a mutation upstream from RAS, that also will signal through RAS and will also turn on that pathway full time. That’s what causes a state that we call activated RAS.

That’s found in overall in about two thirds of all cancers. But the percentage varies quite markedly between cancers and at what stage of development they are at. Cancers that are further along and have a greater tendency to metastasize certainly have a much higher percentage of RAS than early stage primary tumours, that we know. Different cancers tend to have a higher percentage of activated RAS. Pancreatic cancer – we’ve never found one that’s not activated RAS. The more aggressive ones, elemis, malignant gliomas, they are all in the high nineties of percent. The major carcinomas, breast, prostate, non-small cell lung, and ones like that are all around the two thirds to 70 percent range which drives that percentage to two thirds. Its probably the most common metabolic condition that leads to cancer. And that’s a very important number and element for us when were looking at therapeutics to develop new products.

With respect to basic research that goes on. There is a number of programs going on in groups that are collaborators of ours and are not collaborators of ours that continue to look at RAS, the Reovirus, and associated viruses like adenovirus that look at that. This is just a selection of papers found on our web site that we like to direct people towards to look at basic research that’s continuing in the area. Basic research continues in the area of looking at these therapeutic uses, different cancers that can be used, different viruses and that. This is really just a sampling to indicate that there is an increasing number of publications in the area and an increasing amount of activity and labs not directly associated with the company other than occasionally sending them virus and occasionally sending them small amounts of money.

With respect to the clinically development strategy, the company really has settled on three programs that we’re really addressing and splitting into with respect to the clinical program. The first addresses a very important program which is systemic program. Much of the work that we’ve done in the last five years has been directed in a step-wise fashion to yesterday. When yesterday afternoon an IV bag was put on a patient in the UK and the first time every Reovirus was administered through a vein into a person’s body.

The reason why I said systemic administration is that most metatastic disease is not amenable through direct injection and many primary tumours are in places that it is just not easy to reach through surgery or through other means. For us to administer the product intravenously is extremely important. We’re right on the threshold of having a way of administering the product that allows us to address hopefully that larger number of cancers.

We will continue on with our local or regional administration. Local is direct injection into a tumour. Regional is distraction through an artery usually into a specific area. Looking at specific cancers using the virus as a mono-therapy by itself and this is expressed in our ongoing glioma program.

We are also increasing our interest in an area, this is an area of a large amount of interest with our NCI collaboration. Looking at the Reovirus in combination with other approved therapeutics. Radiation, chemotherapeutics for specific cancers, either through local administration in combination, or in combination with systemic administration.

So it’s a program really split into three focuses going forward. This is just a pictorial of it. The whole program that we’ve done so far has been sort of a cascade leading to the later stage studies that we feel we need to do to get this product approved in the future.

We started out with, and I’ll be going over in detail of this, we started out with a very benign form of therapy, which is direct injection into subcutaneous tumours. That was thought to be the safest route of administration. It also gave us a way of determining whether we were seeing any activity in tumours in a very coarse way.

From there, once we determined it was safe to administer that way, we went on to two other local studies, one that’s still ongoing, which is our glioblastoma study where we are directly injecting into the brain which is a much more aggressive environment if you think about it. Its one thing to inject a virus under a piece of skin, its another to inject it into the middle of your head. Its been a flow into this more aggressive form of therapy.

And, to a very technical study, which was our T2 prostate cancer study. Which was also a deep gland, not a surface gland, not on the surface, I can testify personally. I wish it was when I went to the doctor every year. Sorry, I couldn’t help that! Its an awful thing to talk about. But it’s a deep gland and again the way we ran this study is all be telling you it gave us some very specific information that allowed us to determine again safety elements and some very specific histopathology end points which were critical for us to be able to go into systemic administration studies.

So the path flows from there into systemic administration. Now that we’ve initiated our systemic administration, we can either through direct injection or through systemic look at combination therapy studies in the new feature as well. There is a flow from study to study to study. This is a fairly unique flow in the viral area. You won’t see these kinds of different administration routes, and we’re on our fourth administration route starting yesterday, normally in therapeutics.

Our phase one study, and this is going back a couple of years ago, we enrolled 18 patients here in Calgary. They were all terminal cancer patients, end-stage patients who had been treated many many times with chemo, with radiation, and usually surgery as well. Very short life span.

The primary goal of this study was to look for serious adverse events or dose limiting toxicology through an intratumoural administration of the product. There was none. We did not have a serious adverse event or a DLT in this study. And what we detected was we did find tumour changes, and this is measured two dimensionally, 11 of the 18 patients we actually had a 30% or greater two dimensionally tumour regression some time during this study. This is very important. An early indication that the product actually has activity in a human tumour, actually the first indication in the human, in-situe.

We also notice some things that are of great interest going forward. I’ll talk about some interesting things in with respect to radiotherapy with this study. We also noticed what we call field effects where tumours adjacent to the injected tumour also shrank over time and over various periods of time which is also very important.

This flowed into the second study which is our T2 prostate study. It’s a small study. We found the information we needed in six studies. We didn’t feel it was necessary to enrol anymore. One thing you need to understand with clinical studies is that they are experiments. But they are experiments on humans, so once you actually derive the information you are looking for you stop, you don’t just keep experimenting for the fun of it. And we had the information that we needed after six patients so we stopped the study.

The clinical end points were met in this particular study. We didn’t have any severer adverse events or dose limiting toxicities. Again, with this deep intratumoural delivery. After we treated the patients, several weeks after, we actually took out their prostate glands which is the standard therapy for T2 prostate cancer. Very successful I might add to get routinely 10 year survival times with surgery in this cancer. So we had the gland and we were able to look at the gland and look at what was inside of it and do histopathology which is just slicing up the gland and staining it selectively for various things. We found some interesting thing here. We found that we had evidence that the virus was killing tumour. It was an apotic cell death which is as we predicted and as per theory which was gratifying. We also had in one case that we couldn’t find apostasies but we had a clinical response which we weren’t specifically measuring but that was interesting. From that perspective it was quite successful.

We also found that we didn’t have in the adjacent healthy tissue, any evidence of adverse viral effects. It is very very difficult to get the same piece of tissue out of a bunch of patients to demonstrate that specific element. It was a very unique study. To be able to get the same gland out of half a dozen people and show that specific element was a prime goal of this study. We are quite quite pleased that that was actually what we found.

We also found evidence of selective immune cell infiltration which I will not comment on further because this an area of great interest to us, in the tumour mass. I think you’ll be hearing more about that in the months to come.

The ongoing study we have going is a phase 1|2 study here in Canada for malignant glioma. It’s a direct injection again into the tumour mass. There is a little hole in the head, these patients have all been heavily pre-treated so we have lots of ways unfortunately of going back into their heads. We do a direct injection, a stereo-tactic injection of the virus directly into the tumour mass. Its an on-going study so I won’t comment on the patient status or the ongoing results. The primary end-point in a safety study is of course safety but we are also looking at things like tumour response, survival, and Karnovsky performance.

Late last year we announced an agreement with the National Cancer Institute in the United States. An NCI agreement is important for a number of reasons. First of all, the NCI is involved with the vast majority of products that end up getting registered in the United States. So its important if you can to have the NCI involvement at some stage in your process. Secondly, they provide full financial support for the clinical studies. We provide the product, they pay for the studies. And thirdly, and most importantly, honestly, is that they have a great and huge reservoir of expertise and great investigators. You get access to that program, that network through working with them.

What they are interested in looking at is a variety of different cancers which are still being defined. There was two conditions that they need satisfied post the agreement before we could actually start doing clinical studies. The first was assurances from us that we had actual clinical material produced with our new manufacturing process sitting on the shelf. And that condition has now been met. Secondly, they are primarily interested because this is the way cancer therapy is usually done. Is looking at combination. They are looking at radiation therapy plus Reovirus and standard chemotherapy plus Reovirus. So we needed to go back into the lab as I’ll be discussing in more detail and determine in the lab which combinations work and which ones don’t work. Again, the last thing you want to do is run a clinical study on humans with something you haven’t determined works back in animal models. I’ll be discussing that in more detail.

Its very important and we are quite pleased to have this collaboration and I’ll be discussing some timelines later on.

I addressed this briefly at the start. From a systemic administration it is the largest patient population. You can certainly address most cancers more efficiently with systemic administration of a product. For small molecule chemotherapeutics often this is where people start. But we are talking about a live infectious disease agent no matter how benign that is what we are talking about. We are putting an IV bag of virus and injecting it into a person deliberately. This is something that goes against my training. I have a PhD in microbiology and I was taught to do exactly the opposite of this which was not to do this. So it was very important for us to step-wise into this to be very cautious to ensure that every stage prior to yesterday was done right. I think we did that. The product was well tolerated in toxicology studies in three animal species. We did rats, beagle dogs, and unfortunately primates because that is the requirement. Very high dosage, daily administration for 28 days at dosages that will exceed human dosages. In that entire animal group, we didn’t see a single severe adverse event or dose limiting toxicology. Very encouraging but until you actually put it in a human, you don’t know. But we have done that in one human anyway now.

We have very strong pre-clinical evidence of activity in animal models. We can treat metastasis disease in animals pretty well. We have that very very intriguing tumours not injected with the virus observation out of our phase one study that enticed us to think about doing a further study in this particular area. We gained approval for this in February in the UK. The clinical site is the Royal Marsden. One of our reasons for selecting the Marsden is the patient load. It is the largest single site comprehensive cancer center. When you are doing a single site study it is important to have a large patient load so that the enrolment goes appropriately. More importantly, the clinical group we are working with there, is amongst the best in eh world and has done some very interesting and unusual clinical studies with other biological agents. That kind of experience base is very important for us.

This study is what we call a dose escalation study. We start at a relatively low dose, single injection, go up to a very high dose, multiple injection. It has two unique features: one is that there is a repeat therapy component in this study. Patients that are showing any sort of benefit on a monthly basis can get re-treated which is very important to us, corporately and personally I might add. Secondly, there is a small appropriate if we find activity and we get to the right dosage, small phase two arm built into to the study. It will be up to forty patients with current or metatastic solid tumours in this study.

Another unique feature I think with the UK to note is that we tend to get patients earlier on in the disease course. In North America you often in early studies get patients that have failed five, six, ten therapies sometimes. In the UK in this study patients will have failed one or two therapies typically before they get into this study. The patients are much earlier on and will have a much better profile for us to determine safety and activity. And I might add that its not on this slide because it was too late but we did imitate that study and announced that after the markets closed today.

When you are doing clinical studies and work you often observe things that are important but they are observations usually in a patient or two. Those observations often tell you to go back into the lab to do other things. Other times you determine there are other things you should be doing back in the lab to protect your core assets which in this case is the Reovirus. Or to explore other areas that you may need to look at. This is what the basis of our ongoing development program is.

The first is looking at other viruses that we actually engineer to target the RAS pathway; other RAS active viruses. This collaboration is with Dr Allemany in Barcelona in Spain. He’s modifying adenoviruses so that they now will target and only grow in RAS active cells. Very important work. Really it has two functions. The first is its protective because we don’t really want someone else coming up with a RAS active therapeutic to say its kind of like Reovirus. This blocks that certainly. And secondly, he’s discovered some very very interesting things on adenovirus which are the subject of some interesting IP filings.

We are also looking at combination studies primarily. We had observations in our phase one study, and for those of you who have read our patent applications which I know there are several in the audience who do that, there was an example in the claim where we actually took it out of the case report form for the patient where the patient actually had a large head and neck tumour that had been treated with radiation and hadn’t had any effect. We treated on the other side with Reovirus in a smaller tumour. That tumour went a way and nothing happened in the big tumour. Out of desperation they re-treated the big tumour with radiation and it melted away. Nice observation, tumour that wasn’t responding, then responded. We had a belief, based anecdotally anyway on our phase one data that it was radio sensitizing. Back into the lab you go. So we are actually doing the animal model work now to determine the extent of radio sensitization, to determine the correct dosing regimes, the gaps between Reovirus and radiation. Early data is encouraging that Reovirus is actually a potent radio-sensitizing agent. Kind of interesting!

We’re also looking, and this is more with our NCI collaboration, looking at Reovirus in combination with chemotherapeutics. The idea is to see if its additive (1+1=2), super-additive (1+1= ten or five or some number bigger than two), or not additive (1+1=zero) which happens. We are finding some interesting patterns. We are finding some drugs are additive or possibly super-additive with Reovirus and some aren’t which is good to know before you go into the clinic. Once this work is completed, that will form basis for us to get into the clinic with the NCI collaboration.

This year we established the Scientific Advisory Board. To start it would be important to note them. Dr Allemany, has big pharma and academic credentials of the highest calibre in the adenovirus area. He is providing a lot of that experience to bring to bear on our Reovirus program. Dr Gorlick specializes in sarcomas at Sloan Kettering and will be involved with our systemic study in the United States. Alan Tuchman is an interesting hybrid. He both has investment banking analyst experience and is a practising doctor in neurology and has brought a huge amount of experience and capability to bear on our clinical programs. And Dr Frank Tuffaro who started the company called Neurovire(sp?), which was formally in Vancouver and was bought by a German company called Medigene. He was the first person to actually treat a human being with a herpes virus construct. He has a depth of experience in clinical studies and as he says he’s made every mistake in the book and he’d love to bring that to bear on the Reovirus and we are happy to have him do so. We are very pleased to have this SAB and it’s a very interactive SAB and they are quite quite helpful.

There are a number of elements with respect not typically science but business development that also determine the progress of Reolysin through its development under business development. One of those is intellectual property. We now have 11 US patents and European patents issued. We file in the states first. You tend to get this cascade of US approval first followed by other jurisdictions. We have patents approved in other jurisdictions but we just don’t report on them because the European and US ones are the most important. Five of those issued in 2003. We now have issued claims that cover most of the areas I think of interest, certainly in the area. We continue to aggressively file intellectual property in these areas based on what we see in the clinics, based on our basic research programs, and based on long distance flying that Matt and I do all too much.

Manufacturing. Last year we announced technical of a process. Then the challenge was to transfer that capability from an engineering perspective to clinical practise and actually to a manufacturing group and actually have them manufacture product for clinical supplies to supply our new clinical studies with this new manufacturing process. That process has been successfully transferred internally at bio-reliance and the product that was produced and shipped to the UK was produced by BIO Reliance, who has been our long term collaborator in the area of manufacturing. We also added a second supplier, Cobra, in the UK, partially for redundancy and partially for geography to allow us to have a secondary supplier. That tech transfer process is ongoing with them as well. Very very important though. This process impinged on our ability to run clinical studies in the states. The process was important for us going forward because this process will be the basis for the process that we go forward hopefully to product approval and finally product sales with. Its important to fix it relatively early. We believe this meets that standard.

Financials. Last year when we had an AGM and we were standing here, we had about between eight and nine months of burn rate left on cash resources. The challenge for us was to in a difficult at that time financing environment to move forward to raise the resources to ensure that the company had financial resources to take us into the future. One of the things about financing in biotech I think that deserves attention is that often it doesn’t matter how much progress you’ve made or what your stock price is or whatever. It matters whether you can actually raise money and we call it these windows of financing. They come and they go. Unfortunately, there is more often periods where you can’t raise money in biotechnology then when you can. We have been I think very successful in the last year in exploiting assets and resources and financing in a step-wise increasing value manner to add financial reserves. We did four separate financings including a bought deal with Cannacord and several private placements. We sold our asset, mentioned earlier, in Transition Therapeutics which was what started off this cascade actually. Right after we sold the Transition Therapeutics asset, on the same day, actually it was announced, we had three offers of private placements from people who were waiting for us to do something and re-focus it on Oncology. We also sold our shares of BCY Life Sciences. We’ve had an ongoing exercising cascade of warrants issued in previous financing being exercised. We’ve added actually about 5 million dollars to our cash reserves over the lifetime of the company by the exercise of warrants. Given all that we have adequate resources to finance our operations into early 2007. It’s a much much improved financial position then when we stood before you a year ago. And honestly is I think a source of gratification for us to actually have done so.

Just with respect to market and capital data, I’ll draw your attention to the bottom number. That number is actually lower than the number we raised in the last year. So if we hadn’t have done those activities we wouldn’t be having this meeting here today, just as a comment. Fully outstanding, shares are around 29 million. Fully diluted are 35 million – half of which are options and half of which are outstanding warrants that expire mostly over the next year to year and a half. And we trade both on NASDAQ now and on the Toronto Stock Exchange with about equal trading volume more or less on any given day between the two exchanges.

Looking ahead. I think you can look ahead for things that Oncolytics will be working on. I think now that we have our manufacturing in place and we have clinical supplies we can now proceed to supply that information to the FDA and look forward to having our IND approved in the United States for our phase 1/2, or phase one GBM in the United States. Again for the same reasons, given that we have or are beginning to get our co-therapy data out of animals and now have clinical supply we can now look forward to opening and getting going on our NCI collaboration. This is a little out-dated as of a few hours ago, but we can continue with the filing process with the systemic study, but it is somewhat complicated by the fact that we are already treating patients in the UK. We will look forward to getting early results out of our systemic study in the United Kingdom and getting our results from our ongoing GBM study in Canada.

I’d like to thank you for your time and attention. Thank you very much.



This message (Post #7951928) has been viewed 234 times

[merx]

Hallo an alle ONC-Investors

Wie geht`s weiter ???

Wann werden erste Ergebnisse vom Marsden Hospital bekannt ???


Am Freitag schöner Sprung nach oben .........

Waren es die Shorties ?????

schönen Sonntag wünscht

m e r x

[merx]

Mitteilung übermittelt von PR Newswire. Für den Inhalt ist allein das berichtende Unternehmen verantwortlich.


CALGARY, Canada, May 26 /PRNewswire/ -- Die Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) gabheute den Beginn der Patientenbehandlung ihrer klinischen Phase-I Studien zursystemischen Verabreichung von REOLYSIN(R) bekannt, in der REOLYSIN(R) in derBehandlung von Patienten mit fortgeschrittenen oder metastasierenden solidenTumoren untersucht wird.

Diese klinische Studie ist eine Open-Label Phase-I-Studie mitDosiseskalation, in der REOLYSIN(R) solchen Patienten intravenös verabreichtwird, bei denen fortgeschrittene oder metastasierende solide Tumorendiagnostiziert wurden, die auf Standardtherapien nicht ansprechen oder fürdie keine Standard-Heiltherapien existieren. Das Hauptziel der Studie bestehtdarin, die maximal verträgliche oder tolerierte Dosis (MTD), diedosislimitierende Toxizität (DLT) sowie das Sicherheitsprofil von REOLYSIN(R)zu bestimmen. Zu den sekundären Zielsetzungen zählen die Einstufung derviralen Replikation, der Immunreaktion auf das Virus und jegliche Hinweiseauf tumorbekämpfende Aktivität. Es wird erwartet, dass bis zu 40 zur Analysegeeignete Patienten an dieser Studie teilnehmen werden. Diese Zahl hängt vonder Anzahl der geprüften Dosisniveaus ab. Der Forschungsleiter für dieseStudie ist Dr. J. de Bono vom Royal Marsden Hospital.

Näheres über Oncolytics Biotech Inc.

Oncolytics ist ein Biotechnologieunternehmen mit Firmensitz inCalgary, das sich auf die Entwicklung von REOLYSIN(R), der gesetzlichgeschützten Zusammensetzung des menschlichen Reovirus als potenziellesKrebstherapeutikum spezialisiert. Oncolytics-Forscher konnten nachweisen,dass das Reovirus Krebszellen selektiv abtötet und in vitro von vielenunterschiedlichen Krebsarten, einschliesslich Brust-, Prostata-, Pankreas-und Gehirntumoren gewonnene menschliche Krebszellen töten kann. Zudem konntensie in einer Reihe von Tiermodellen eine erfolgreiche Krebsbehandlungnachweisen. Die Ergebnisse der klinischen Phase-I-Studien haben gezeigt, dassREOLYSIN(R) gut verträglich ist und dass für das Reovirus bei mit REOLYSIN(R)injizierten Tumoren Aktivität nachgewiesen werden konnte.

Diese Pressemitteilung enthält in die Zukunft gerichteteAussagen im Rahmen der Definition von Paragraph 21E des Securities ExchangeAct aus dem Jahr 1934, in der abgeänderten Fassung. ZukunftsorientierteAussagen, einschliesslich der Erwartungen des Unternehmens hinsichtlich derResultate der Phase-I-Studie zur Untersuchung der systemischen Verabreichungvon REOLYSIN(R) in Grossbritannien und die Annahmen des Unternehmensbezüglich des Potenzials von REOLYSIN(R) als Krebstherapeutikum beinhaltenbekannte wie unbekannte Risiken und Ungewissheiten, die dazu führen könnten,dass die tatsächlichen Ergebnisse des Unternehmens erheblich von den in denzukunftsorientierten Aussagen angegebenen Ergebnissen abweichen. DerartigeRisiken und Ungewissheiten beinhalten u.a. die Verfügbarkeit von Mitteln undRessourcen zur Durchführung von Forschungs- und Entwicklungsprojekten, dieWirksamkeit von REOLYSIN(R) als Krebstherapeutikum, den Erfolg und denplanmässigen Abschluss klinischer Studien, die Fähigkeit des UnternehmensREOLYSIN(R) erfolgreich und kommerziell zu verwerten, Ungewissheiten inVerbindung mit Forschung und Entwicklung von Pharmaprodukten sowieUngewissheiten in Verbindung mit aufsichtsbehördlichen Vorgängen undallgemeinen Veränderungen im wirtschaftlichen Umfeld. Anleger sollten weitereInformationen über Risiken und Ungewissheiten im Zusammenhang mit diesenzukunftsorientierten Aussagen den Quartals- und Jahresberichten desUnternehmens bei den kanadischen und amerikanischenWertpapieraufsichtsbehörden entnehmen. Anleger werden darauf hingewiesen,sich lediglich im entsprechenden Rahmen auf zukunftsorientierte Aussagen zustützen. Diese zukunftsorientierten Aussagen werden vom Unternehmen nichtaktualisiert.

Oncolytics Biotech Inc

ANSPRECHPARTNER FÜR WEITERE INFORMATIONEN: Für Kanada: Oncolytics Biotech Inc., Dr. Brad Thompson, 210, 1167 Kensington Cr NW, Calgary, Alberta T2N 1X7, Tel: [phone], Fax: [phone], www.oncolyticsbiotech.com. Für Kanada: The Equicom Group, Joanna Longo, 20 Toronto Street, Toronto, Ontario M5C 2B8, Tel: [phone] Anschl. 233, Fax: [phone], [e-mail]. Für die USA: The Investor Relations Group, Gino De Jesus or Dian Griesel, Ph.D., 11 Stone St, 3rd Floor, New York, NY 10004, Tel: [phone], Fax: [phone], [e-mail]

26.05.2004, 26.05.


Druckversion | Nachricht weiterleiten

[merx]

Tumor Math
by: gloworm1707
Long-Term Sentiment: Strong Buy 06/05/04 04:17 pm
Msg: 20003 of 20019

re: h**p://web.mit.edu/lwein/www/bulm0245a.pdf

Some key facts from the mathematical model by WU and Byrne on ONXX-015 (an adenovirus). It is much larger than REOVIRUS. And the cell bursts with a factor of 1000 progeny virus at the 48th hour after infection. See page 10 table 1 – BURST SIZE, and infected cell death rate constant

Reovirus bursts a cell with typically 10 times as many because it is so small, at the 18th hour after cellular infection.

In the direct injection section, the study shows that it can take up to 3000 hours to eliminate a tumor completely – see page 11. This is up to 4 months. Later the model shows that if the adenovirus is injected into the middle of the tumor, it takes up to 3 months to reach the outer shell of the tumour, and infect all of the cells which are in the wave front of the cancer. see section 4.2 page 17. By that time most of the cells in the middle are dead.

Page 33 gives a minimum percentage, .05%, of the tumor which must be infected initially in order to eliminate the tumor. Otherwise the tumor grows faster than the virus can spread. It would be interesting to see this kind of model for Reovirus. Reovirus should work faster than adenovirus in direct injection.

Importantly, we can also use an intravenous route because the bodies immune response is relatively weak to reovirus. This allows us to spread the initial infection to many more cells hopefully than direct injection, and includes all metastises, known and unknown. So it should take less than 4 months to clear the tumor


Auszug aus dem Yahoo-Board

[Dead_Bull]

Wie geht es weiter? Gibt es was Neues?

Warum der Absturz?
Bitte nur ernsthafte Kommentare!

[r.schaui]

@all,
zu dem Absturz gibt es zur zeit keine ernsthaften erklärungen, die üblichen gerüchte und mutmassungen siehe auch im diskussionsforum
http://www.stockhouse.ca/bullboards/forum.asp?symbol=ONC&tab…
ergebnisse der im mai begonnenen klinischen testreihen in UK sind noch nicht bekannt - jedenfalls nicht uns aktionären
mfg
r.schaui

[r.schaui]

@dead_bull
vielleicht gibt die folgende meinung eines teilnehmers im stockhouse thread eine plausible erklärung:

I listented to a Bloomberg radio analyst interviewing `experts` this morning on the ride in. To sum it up the market and Biotec`s in particular have been hit very hard and according to the index/ratios one guy follows he believes that the market and in particular biotecs are bottoming and should reverse soon. People are reluctant to buy now because of the threat of another attack at Dem or Repubican convention or at the Olympic games. Also people are waiting until they can percieve how the US election will go. I have no idea if they are right but it does sound plausable - just thought I post the gist of what was said. Call it "grasping at straws`. At any event I`m still holding my ONC - and looking for the reversal. Thanks for that previous post from DOIT - an optimistic post in a sea of pessimism!
XYZ
Posted By: xyz1308
Post Time: 7/27/04 11:40

ich bleibe vorerst investiert
mfg
r.schaui

[r.schaui]

ich glaube, dass wir bald mit den ersten ergebnissen rechnen können

gefunden im stockhouse bullboard heute

ONC Company Snapshot

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SUBJECT: The Royal Marsden and St. George`s Hospital Posted By: OwieOwie
Post Time: 7/29/04 09:17
« Previous Message Next Message »

taken from the ONCY board on yahoo:
Re: the Royal Marsden + St. George`s
by: riothalmus (M/Britanny) 07/29/04 09:00 am
Msg: 23004 of 23004

"Preliminary analyses of an attenuated Reovirus-3 vector in combination with radiation in vitro and in vivo are in progress. Viral vectors expressing the sodium iodide symporter (NIS) gene have been made as a means of exploiting the diagnostic and therapeutic role of radioactive iodine in cancers other than thyroid cancer. Constructs containing different tissue- and tumour-specific promoters have been designed. In vitro analyses have been performed in non-thyroid solid cancer (colorectal, head and neck) models.

This programme of preclinical work is being carried out in the context of an active programme of clinical research for patients with head and neck cancer at the Royal Marsden and St George`s Hospitals."

This paper suggests that ONCY has expanded its clinical development program and has enlisted another clinical research center in the U.K. namely, St. George`s Hospital in London England.

St. George`s Hospital is one of the most presitgious hospital centers in all of England. "

r.schaui

[Dead_Bull]

Danke!

[r.schaui]

Bitte

[r.schaui]

oncolytics hat genügend cash bis 2007 !!!

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SUBJECT: Q2 Report - Onc increases its cash balance Posted By: whosyurdaddy
Post Time: 8/5/04 08:56
« Previous Message Next Message »

Oncolytics Biotech Inc. Announces 2004 Second Quarter Results
CALGARY, Aug. 5 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC,
NASDAQ:ONCY) today announced its financial results for the three and six-month
periods ending June 30, 2004.

Second Quarter Highlights:

- Commenced enrolment in a Phase I systemic (intravenous) administration
clinical trial at the Royal Marsden Hospital, Surrey, U.K.

- Strengthened the Board of Directors with the addition of
Mr. J. Mark Lievonen, President of Aventis Pasteur

- Completed a $6.73 million private placement with a European
institutional investor. With this private placement, combined with
$4.0 million received from the exercise of warrants and options, the
Company believes it has sufficient reserves to fund its activities
into 2007.

"The commencement of our first systemic administration trial is a
significant milestone for the Company in its development of REOLYSIN(R) as a
potential cancer therapeutic," said Dr. Brad Thompson, President and CEO of
Oncolytics.

LIQUIDITY AND CAPITAL RESOURCES

Liquidity

As at June 30, 2004, the Company had cash of $25,522,728 (including cash,
cash equivalents and short-term investments) and a working capital position
of $25,234,266 compared to $20,752,735 and $20,088,868 respectively as at
December 31, 2003. During the second quarter of 2004, the Company continued
to improve its cash position through a private placement of 1,077,100 units
at an average price of $6.25 per unit. Net cash proceeds after issue costs
were $6,223,763 and each unit was comprised of 1,077,100 common shares and
538,550 common share purchase warrants. Each whole common share purchase
warrant entitles the holder to acquire one common share of the capital of the
Company upon payment of $7.75 per share until October 7, 2005. The Company
also received cash proceeds from the exercise of warrants from previously
closed financings of $3,300,038 and from the exercise of stock options of
$740,983. Consequently, for the six month period ending June 30, 2004, the
Company has received a net amount of $10,264,784. This increase in the
Company`s cash position has been offset by cash outflows from operating
activities of $5,194,579 and purchases of intellectual property and other
assets of $433,821.
The Company desires to maintain adequate cash and short-term investment
reserves to support its planned activities which include its clinical trial
program, production manufacturing, and its intellectual property expansion and
protection as well as administrative activities. The Company believes that its
existing capital resources are adequate to fund its current plans for research
and development activities into 2007 without presuming the further exercise of
outstanding warrants and options. In the event that the Company chooses to
seek additional capital, the Company will look to fund additional capital
requirements through the issue of additional equity as well as potential
partnering or licensing opportunities.

Oncolytics Biotech Inc.
BALANCE SHEETS

As at,
June 30, December 31,
2004 2003
$ $
(unaudited) (audited)(*)
-------------------------
ASSETS
Current
Cash and cash equivalents 3,058,642 2,641,127
Short-term investments 22,464,086 18,111,608
Accounts receivable 63,618 64,224
Prepaid expenses 566,331 156,837
-------------------------
26,152,677 vs previous 6 mo. period ending Dec. 31, 2003 20,973,796


http://www.newswire.ca/en/releases/archive/August2004/05/c86…

mfg
r.schaui

[r.schaui]

zur kursentwicklung von oncy, der boden ist erreicht, die schwachen hände sind draussen

extracted from the Yahoo board:
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

Some analysis
by: xd327_2004 08/07/04 09:54 am
Msg: 23435 of 23438

1) Technical Analysis

The last 2 days were interesting: Both days the stock finished with little change (~3,6 US$). It tested three times US$3,4 under low to average volume conditions and ended strongly. It also ended the week with losses comparable to the ^BTK and the ^IXIC (-5%). These are good signs for a small bio.

http://finance.yahoo.com/q/ta?s=ONCY&t=5d&l=on&z=m&q=l&p=b&a…

There have been lot of selling pressure the last 4 weeks. More than 1,5 million shares were trade 3,5 weeks ago (12-14 July) with a low at US3,4 and more than 500 thousand were trade about 1,5 week ago (26-28 July) with a low at US3,2. These last three days, about “only” 250 thousand shares were trade with a low yesterday around US3,30: this indicates that the bleeding is coming to an end.

http://finance.yahoo.com/q/hp?s=ONCY

The RSI on 13 July and 27 July clearly indicates an oversold situation (20). Currently the RSI is floating just above the oversold indicator (30). The MACD is also getting positive now.

http://stockcharts.com/def/servlet/SC.web?c=oncy,uu[w,a]daol…

It means that shares are now held in strong hands only: stop losses and margin calls were triggered, and panic sellers have sold.

What is also very interesting is that the recent “bad-and-maybe-fake” letter from “21st Century Alert” had none to little impact on the price: this indicates that the remaining long investors are not stupid and did not sale.

The stock is coming from a high of US$9,84 in April 2004. Last year, at the same period it was above US$2,20 and finished in September at US$3,20. In the meantime there has been a lot of good news and more good news are coming (I think, see the conclusion part).

So I believe that the current price is a very good entry point. Of course the overall market is very weak currently, and it is hard to tell when this will end. But we all know that the best buying opportunity are to be found during weak market conditions.

By the way, from a pure fundamental perspective only, the long term value of this company should not be compared too much to the indices that depend on the current economic conditions: the revenues of ONCY will largely depend on a drug that, one day, a huge part of the cancer population of North America, Europe, Japan, etc, will probably need and be ready to pay for, whatever their own economical situation is.


2) Fundamental Analysis

I try to develop here an approach to estimate the current value of ONCY. There has been already lot of posts on this difficult topic. Thanks to RJC, the long term value of ONCY can be found on the following site (with some new and very nice pictures):

r.schaui

[r.schaui]

und eine einschätzung zur wirksamkeit von reolysin bei der krebsbekämpfung und der marktkapitalisierung von oncy

http://canadiantreeplanting.com/onc_share_price.html

First I consider the success of Reolysin® alone (success description – probability – Market Cap):

1) Complete failure - 10% - 0$
2) Partial success, niche market (e.g. prostate & glio cancers) – 35% - 3 bn$
3) Medium success, used intravenously in 20% of all cancers – 35% - 10 bn$
4) Complete success, used intravenously in 80% of all cancers – 20% - 30 bn$

So, taking into consideration what I know of the company, my expectation for the long term value is: 10.55 bn$ (300 US $ per share – 35 million shares).

Notes:
a) It is hard for me to believe that there could be a complete failure due intrinsically to the drug alone: the reovirus is simply too safe, and has already shown lot of positive effects. However we can only assume what will be the results of the trial at the Marsden hospital. So it is also very difficult to put probability figures of success for the drug used intravenously.
b) To be on the safe side, I divided by two the results provided by RJC´s web sheet. By the way, the market cap in case of partial success is that way comparable to other similar biotechs with “partial” success stories.

Finally I consider other kind of risks that could happen before Reolysin® receives (FDA) approval (risk description – probability):
1) Financial risks (too high burn rate) – 15%
2) Legal risks (wrong patents) – 30%
3) Partnership (bad agreement) – 15 %

This gives a long term value of 150 US $ per share, which could be achieved within the next 4 years. So, with a discount rate of 20%, the current price would be 75 US $.

3) Fundamental Analysis – Additional Notes:

a) Obviously the market has a much stronger perception of the risks involved than I do. It must be said that the above exercise is very perilous. Big investment firms will only send their analysts when enough data are available for in-depth analysis. This often means after phase II only. But at that time, if everything goes fine, we could see that price of 75 US$. This could be as soon as April 2005, when I expect the final results of the phase I//II Marsden trial to be released.

b) I do not consider the financial and partnership aspects as a big risk. With regard to finance, I saw exactly what I expected to see in the last PR: enough cash in the bank, at least until the start of a phase III trial, which is very good. By the way I am very happy how this company so far did its funding: at the right time vis-à-vis the share price to avoid too much dilution while maintaining a strong cash position. Also, the daily price traded always higher in average the three to sixth months after the offerings (however these data cannot yet be calculated for the last PIPE).

c) With regard to partnership, we know that ONCY is in close contact with two big pharmas, and that they act with the view of easing a partnership deal when the time will come, probably before starting a phase III trial. They have also an impressive advisory board. So I am not worrying there either.

d) The legal risk is probably the higher risk for ONCY. We know that Pfizer could not crack their patent rights, which is very good. However we know also that there is lot of researches going on all around the world on virus-therapies against cancer. The fact that the reovirus is often part of these researches is good news because it indicates the relevance of developing Reolysin® as a drug against cancer. However it also increases the possibility that somebody else finds something interesting that is not described in the patents held by ONCY. This is not harmless because the very wild and common Reovirus cannot be patented as such, only the applications/inventions surrounding the reovirus can be patented.

This may explain why the company has always been very cautious in releasing any information about its researches, trials and patents. I believe nevertheless that they have currently a good level of protection: 11 U.S. patents and 1 European patent have been issued to Oncolytics and numerous other additional patents are filed and pending. (I also understood that they hired one of the best lawyer companies in N.Y. for ensuring the proper filling of their patents).

I believe ONCY to be years ahead of their competitors with regard to using Reoviruses against cancers. However I cannot be 100% sure of this because on one hand we do not know the precise contents of all the patents currently filled and pending by ONCY and its competitors and on the other hand because this is in essence a very complex domain to analyse. (A special thank here to Biotexan, Matdu and others who often post on this board very interesting information on this very complex matter).

4) Conclusions

No news means good news: the longer we stay without news means the longer the trials continue enrolling at their (normal) pace without difficulties. This was confirmed in the last PR. July was a difficult month to go through, probably because this would have been the month when bad news would have been released most probably (in addition market conditions were and are still very bad). No bad news was released, so, from a fundamental perspective, the stock should regain some strength from now on.

There were also some speculations in April of an early partnership, which was completely unfounded. Those who know the company know that BT already gave some indications that the best time for a partnership is certainly at the earliest after a successful phase II trial, when the drug is already well proven and before more cash is needed for an expensive phase III trial. This looks like a pump and dump scheme, and we could be now at the bottom of the dump part of the scheme.

There are also expected news in the pipeline for autumn: mostly on the glio results, on the interim Marsden results and on the ability that the reovirus has to wake up the immune system of the human body to fight its own cancerous cells (this is written with my own words). The latter is of the uttermost importance according to BT.

So we could see the beginning of some stock accumulation.

Of course in the meantime some traders may try to correlate ONCY stock price with the oil price increase, the US election, or maybe the effect of a butterfly’s wing in Tokyo.

r.schaui

[r.schaui]

ONC Company Snapshot

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SUBJECT: RE: ** Technical / Fundamental Analysis on ONC ** Posted By: cardu
Post Time: 8/8/04 19:29
« Previous Message Next Message »

"Given that the market for Reolysin is significantly greater than the HIV and hepatitis markets, I think that any take-over of ONC would not be for less than US$4.5 Billion resulting in a price of at least
US$157.00/share
for ONC or C$208.00 "

r.schaui

[BrauchGeld]

Hi

Kann mir jemand sagen ,warum man jetzt einsteigen sollte ?
Also das die Aktie fast am tief notiert reicht mir nicht aus.
Und sowie es aussieht dauert es unter güngstigen umständen ca.2-3 jahe bis zur Zulassung falls alles gut geht.
Ich bitte um argumente .

Grüsse
B.M.

[r.schaui]

@brauchgeld
wer kann wissen, wann bei einem hochriskanten biotech-wert der günstigste zeitpunkt zum einstieg ist
entweder du glaubst an die story oder lässt die finger davon

seit mai 2004 läuft phase I im marsden hospital london
5/26/04 1:14:00 PM News Release Index


Oncolytics Biotech Starts Patient Treatment in UK Phase I Cancer Trial Investigating Systemic Delivery of REOLYSIN®

CALGARY, AB, --- May 26, 2004 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that it has started patient treatment in its UK Phase I clinical trial investigating the systemic delivery of REOLYSIN® as a treatment for patients with advanced or metastatic solid tumours.

seit dezember letzten jahres eine phase I/II zur Behandlung von gehirntumor

Glioma Clinical Trial

A Phase I/II Clinical Trial to Evaluate Dose Limiting Toxicity and Efficacy of Intralesional Administration of REOLYSIN® for the Treatment of Patients with Histologically Confirmed Recurrent Malignant Gliomas

erwartet wird eine erfolgsquote von 60 % +, was m.w. bisher kein anderes mittel gegen krebs erwarten lässt

zur zeit steigt der kurs wieder, warum ?

hier vermutungen aus dem stockhouse board
taken from yahoo:
Raging Bull heads-up on Positive NEWS

by: newsleaking 08/18/04 11:48 am
Msg: 24025 of 24028

By: uberbroker
16 Aug 2004, 06:07 PM EDT
Msg. 466 of 469

Heads up. UK trials are going fabulously (well, if you can use that adverb when referencing the treatment of people with gliablastoma). Data being obtained is awesome. You heard it hear first. BTW, check out the new media on ONCY`s website. Very nice walk through of ONCY`s science and the viras/RAS pathway.

uber


http://ragingbull.lycos.com/mboard/boards.cgi?board=ONCY&rea…

http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

und insiderkäufe



According to www.SEDI.ca Jim Dinning, a director,
bought 1500 shares of ONC on the 16th and 17th of August for
$4.70 Canadian.
He already owns 55,000 options with an exercise price of $8.10
I believe that this is a small sign of something big that is about to
occur.

Remember: BT doesn`t need to buy shares he has so many options
that he`ll have so much money he won`t know what to do with it.
Good luck longs.
September is going to be a good month.

r.schaui

[r.schaui]

@brauchgeld
der kurs wird nicht erst wieder steigen, wenn die zulassung kommt, sondern spätestens dann, wenn die ersten ergebnisse der laufenden testreihen bekannt werden

wann das sein wird, ist unser vabanque spiel

r.schaui

[Jack_Pott]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[r.schaui]

eine studie über oncy wohl der grund für den kursanstieg der letzten tage

http://www.equicomgroup.com/profiles/ONC-profile.pdf

mfg

r.schaui

[js200]

08/25/2004 (14:10 ET) ONCY: Volume Spike; 44% > 20-adsv, Stock +3.07% - Knobias
08/24/2004 (16:19 ET) ONCY: Short Interest UP 48.7% to 80.5K in Aug 2004 - Knobias
08/23/2004 (10:20 ET) ONCY: Volume Spike; 21% > 20-adsv, Stock +8.88% - Knobias
08/20/2004 (10:41 ET) ONCY: Volume Spike; 13% > 20-adsv, Stock +5.76% - Knobias
08/11/2004 (14:17 ET) ONCY: Filed 6-K Regarding 2nd Qtr Results (Aug-05 PR) - Knobias

JS200

[merx]

Hi all on board of ONC,

was wird uns das Meeting in NC am Montag bringen ???

I hope , neue Trials in London geben Anschub für unser
Engagement. Reolysin als wichtige Combitherapie in Verbindung mit traditioneller Therapie (auch als Schmerztherapie) bringt uns bestimmt weiter.

Go Oncy, go................


Gruß

m e r x

[merx]

9/9/04 5:38:27 AM News Release Index


Oncolytics Biotech Inc. to Present at the Wall Street Analyst Forum

CALGARY, Alberta, September 9, 2004 – Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY), will present a corporate overview of the Company to up to 400 analysts and portfolio managers at the 15th Annual Wall Street Analyst Forum on Monday, September 13 at 9:40 AM (ET). The event will be held at the Roosevelt Hotel in New York, NY.
A live audio webcast of the presentation will be available at: http://www.vcall.com/CEPage.asp?ID=89062 or on the company’s website at www.oncolyticsbiotech.com.

It is recommended that listeners log on 15 minutes in advance of the presentation to register and download any necessary software. An audio replay will be available for two weeks following the presentation at http://www.vcall.com/CEPage.asp?ID=89062.

About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics’ researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

The webcast time is subject to change. This release and the presentation related thereto contain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company’s control and which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or expectations implied by these forward-looking statements.

FOR FURTHER INFORMATION PLEASE CONTACT:

For Canada:
Oncolytics Biotech Inc.
Cathy Ward
210, 1167 Kensington Cr NW
Calgary, Alberta T2N 1X7
Tel: [phone]
Fax: [phone]
www.oncolyticsbiotech.com

For Canada:
The Equicom Group
Joanna Longo
20 Toronto Street
Toronto, Ontario M5C 2B8
Tel: [phone] ext. 233 F
ax: 416.815.0080
[e-mail]

For United States:
The Investor Relations Group
Gino De Jesus or Dian Griesel, Ph.D.
11 Stone St, 3rd Floor
New York, NY 10004
T: 212.825.3210
F: 212.825.3229
[e-mail]
-30-


News Release Index

[muycaro]

Auf der Konferenz hat BT einen normalen Corporate Overview präsentiert, mit wenig Neuigkeiten (sieht man auch am kurzfristigen Kursverlauf. Hier wurde auf News spekuliert).
Hier sind die dazugehörigen Slides (bitte etwas warten bis alle geladen sind), die gezeigt wurden (sehr interessant finde ich allerdings Punkt 4 auf Dia 16 - ebenfalls BT Kommentar, dass eine zweite Versuchsreihe inkl. Intravenöser Verabreichung von Reolysin im St. George`s Hospital schon demnächst beginnen soll):

[muycaro]

Beim Upload wurden offensichtlich einige der ersten Slides vertauscht. Hier ist nochmal der Link zu meinem ONCY Album inkl. richtiger Reihenfolge (man beachte die Numerierung von 1-23):

http://photobucket.com/albums/v479/muycaro/

[muycaro]

Habe gerade keine Zeit mehr, deshalb hier nur noch schnell ein kurzer Beitrag vom Yahoo Board, der sich mit meinen Observationen deckt und mich weiterhin so zuversichtlich wie nie zuvor sein lässt (dank zukünftiger neuer Trial Site, dem St. George; der Rückversicherung keiner Nebenwirkungen bei den bisher behandelten Patienten im Royal Marsden; NCI weiterhin am Ball; die Sensibilisierung der Zellen durch Reolysin für Bestrahlungstherapie; etc):

second site confirmed-St George
by: tonwalth (M/Devon, England.)
Long-Term Sentiment: Strong Buy 09/13/04 10:14 am
Msg: 26570 of 26603

-good to hear that ONCY are briniging in another site in the UK into the systemic trials, St georges hospital.This gives a `broader number of indications`

-also good to get an up-date on Marsden....`not seen any adverse events, not reached dose-limit yet`

-update on status of NCI sponsored trials
`working with NCI to file for those studies in the near future`

-good to hear that Reolysin is a `potent radio-sensitizing agent`

-all in all, a positive and confident presentation, with a few new snippets, gives me the `feel good factor` moving forward.

-Got a feeling there is a lot of positive news building up here that is going to blow the lid of this stock when it gets out.





http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

[muycaro]

Noch ein paar Zitate aus dem Interview (dank gilt den Postern bei Yahoo):

Animal models VERY PREDICTIVE
by: proboscises 09/13/04 01:13 pm
Msg: 26629 of 26651

"This is a picture of an immune competent mouse (a mouse with an intact immune system) that`s had a mouse tumor implanted on it. This isn`t a xenograft, it`s a mouse tumor on a mouse. And we can do this with the reovirus because the reovirus is a mammalian virus, not (just) a human virus. So it`s been very predictive to date to look at the virus` activity in the animal and it`s been a very good match-up with what`s happened actually in humans from a safety and clinical perspective. What`s important about this picture, I think, is two things: 1. The animal on the left obviously was not treated with reovirus and you`ll see, more importantly than the tumor, the general wasting that you associate with cancer and a very large lesion on it`s left hind flank. The animal on the right was treated I believe in this case with a ??? injection of the virus intratumorally. But you can do it intravenously and it works the same way, or spray it as a mist into the lungs for lung models and the virus is very adaptable. The animal is sleek, it`s plump, it`s fur is intact, and it actually has bite marks where it has been engaged in normal mating and other types of behavior with other animals. Here`s a key thing with the tumor down in the corner (it`s a little difficult to see this picture). There`s a little nodule left over, and this is a characteristic of this kind of therapy. What we found both in animals and in humans is that after treatment, because the virus is so selective, there`s always something left over that one might think is a tumor, but indeed is NOT a tumor - it`s left over connective tissue. The virus is so selective that it will literally take cancer cell inbetwixt and between supportive tissues and leave the supportive tissues healthy and ???. We`ll get this little nodule pretty much in animals and in humans. It`s kind of an interesting thing to look for.
Compare that (it`s a little difficult to see in this slide) with a patient from our very first original phase 1 study. It`s a female patient with a head/neck cancer on the back over her neck (just on the left side of her nape hair there) and that red mark in the middle is actually where a punch biopsy was, not where the virus was injected. This was an intratumoral administration at the second lowest dose of this study (this was a dose escallation study). And again we see the same characteristics - we see (this tumor was graded actually as a partial response - the tumor flattened out completely) again we don`t see loss of hair, we don`t see tissue disruption around the injection site and we have a lump left over that never grew back - it was completely stable disease and we believe it was again just connective tissue and tissue that is left over after the virus has done its job. It`s kind of nice to historically take a look at animals and to see how those effects actually translate into human beings." - Brad Thompson, Sept. 13, 2004



Systemic trial comments by BT
by: proboscises 09/13/04 02:24 pm
Msg: 26648 of 26653

"Now we are actually treating patients systemically and there are a variety of reasons why it is important for people with viral therapies to move into systemic treatment. Certainly it`s the largest patient population. Probably 80% of that 4 million patients plus I mentioned earlier treatable with this particular therapeutic are only accessible through systemic administration. They either have tumors that are not ammenable to direct therapy, or they have metastatic disease which is obviously not ammenable to direct injection. What we found is the product is well tolerated at all the dosage levels using, unfortunately, primates, cannines, and rodents. And that`s very aggressive therapy. That`s 28 daily infusions of very high dosages of the virus. What you are looking for in daily infusions is things like spiking fevers, ??? cascades, and those sorts of things which have been noted in other viruses, BUT WE HAVE NOT SEEN THAT AT ALL IN ANY OF OUR ANIMALS. We have very strong pre-clinical evidence that you can actually treat systemically with the virus, both metastatic disease and primary tumors. And as I mentioned earlier we had indications in our initial phase 1 trial that the virus is spreading systemically, which is important.
We are currently undergoing a phase 1 component of a systemic administration study at the Royal-Marsden Hospital in the United Kingdom. Starting next month we`ve initiated a second site at St. George`s Hospital for enrolement in October. The purpose of having two sites in the UK is to allow us to expand the usage base out of a smaller group of oncologists to a larger group, and you get a broader number of indications. The different hospitals have different populations and indication bases. Our study is a dose escallation study for up to 40 patients IV. And we are looking of course at maximum tolerated dose and DLT and safetly and we`re also monitoring immune status very closely and looking at tumor responses. Further on in this study, AS OF TODAY WE HAVEN`T SEEN ANY SEVERE ADVERSE EVENTS AND WE HAVE NOT REACHED A DOSE LIMITING TOXICOLOGY AS OF YET." - Brad Thompson, Sept. 13, 2004


Re: Reovirus manufacturing & FDA approv
by: riothalmus (M/Britanny) 09/13/04 12:45 pm
Msg: 26620 of 26654

"We`ve been fortunate in that we`ve been using a naturally occuring virus. They tend to be easier to manufacture than genetically engineered viruses." - Brad Thompson Wall Street Forum September 13, 2004



Re: Reovirus manufacturing & FDA approv
by: riothalmus (M/Britanny) 09/13/04 12:42 pm
Msg: 26617 of 26654

"We`ve successfully completed a process that should be scaleable and based on our conversations with the FDA we believe should meet the regulatory requirements that will be required in the United States. And we`ve actually transfered this from one clinical production group to another clinical production group now, which is important. The ability to transfer a process is really the acid test of whether it`s a robus prt process. Our current manufacturer, BioReliance, is in the process of transfering this process from the United States to the UK, and we have a second supplier, Cobra Biomanufacturing in the United Kingdom, that we`ve brought on. So we are quite pleased that we have a process that appears to be robust and scaleable and actually have product on the self today to support our clinical programs for 2005." - Brad Thompson Wall Street Analyst Forum September 13, 2004



Noch ein Kommentar von matdu zu der Presentation:

Presentation
by: matdu1 09/13/04 01:12 pm
Msg: 26627 of 26654

A few things I noted from today`s presentation-

(1) Expansion of the UK systemic trial to St. George`s next month. Did someone say there was no timeline given. That sounds like one to me.

(2) Preliminary work on radiotherapy+ Reolsysin combination is about half way through.

(3) The NCI work on chemo+Reolysin combination revealed the following: 5FU, Gemzar, DOX and Cisplatin all showed synergistic effects with reovirus, while Taxol did not.

Among those that have shown promising results with Reolysin, there are antimetabolites (5FU and GemZar), antineoplastic (DOX) and an alkylating agent (Cisplatin). And they cover a variety of cancers: 5FU for colon cancer, rectal cancer, breast cancer, stomach cancer, pancreatic cancer, ovarian cancer, cervical cancer, and bladder cancer.

Gemzar is used commonly for pancreas and lung cancers. DOX is typically used to treat some kinds of cancers of the blood; lymph system; bladder; breast; stomach; lung; ovaries; thyroid; nerves; kidneys; bones; and soft tissues, including muscles and tendons. Cisplatin is commonly used in treating cancer of the bladder, ovaries, and testicles.

The implication of these new findings is that not only Reolysin can be used to treat about two thirds of cancers as a monotherapy, it can also be use in conjuction with some of the aforementioned chemo agents to treat a large # of cancers regardless if they are RAS-acativated or not. These kinds of combination treatments might well be the answer to the resistance issue concerning many of the chemo and radiation therapies currently employed.



Nächste Termine:



07.10.2004: Bio Contact Conference in Quebec

08.11.2004-10.11.2004: Bio Europe 2004 partnering Conference in Köln

[muycaro]

Jemand aus dem Stockhouse Board hat sich die Mühe gemacht, die einzelnen Kommentare zusammen zu fassen und ein komplettes Transcript erstellt (aus meiner Sicht besonders interessante Passagen habe ich fett gemacht):


2004 Sept. 13 Wall Street Analysts Conference presentation by Dr. Brad Thompson.


I would just like to draw your attention to our forward looking statement. Oncolytics trades on NASDAQ. And I`d also like you to peruse our SEC filings and filings in the Canadian securities environment.
Oncolytics biotech is an oncology company. Our technology focus is on using oncolytic virus to infect and selectively kill cancer cells. There are a number of companies looking at a variety of different viruses. And the area that we are focusing in is one virus that actually selectively infects and kills what we call RAS active oncolytic viruses and I`ll be talking about that briefly.

Our products name is Reolysin and its really a formulation of the naturally occuring virus called the reovirus - thats where the reo comes from. REO stands for Respiaratory Enteric Orphan virus and this is one of an incresaingly large number of viruses that are called orphan viruses and these are viruses that are not thought to cause any human pathology. Us, in the area, believe that it is likely that most viruses will turn out to be orphan viruses but they haven`t been very well studied because they don`t cause disease.

As I mentioned the reovirus is a naturally occuring virus. We are using a completely naturally occuring form. The virus we are using actually was identified and isolated in the nineteen fifties and has been used as a research tool since that time, and it is what we call a fully replication compitent virus. So this is one of a group of viruses that will actually naturally infect a cell and go through a complete replication cycle killing the cell and infecting adjacent tissue. As I mentioned the virus is asymptomatic in humans. And it was thought very early on that the reovirus must cause something. And this was evidenced by people looking at the ??? antibodies in different patient populations THere was a study done in teh early nineteen sixties by Rosen et al who looked at a large volunteer population and found that the virus is associated with no clinical pathology whatsoever. And that was really the starting point for the work with the reovirus.

This virus is a type of virus that infects both normal and cancer cells. Some viruses will actually differentiate between cancer cells and normal cells based on surface antigens. This is one of the other group of viruses which actually will infect all cells. Its what happens inside the cell that differentiates between the activity or non activity of the virus. Once inside the cell the virus will uncoatand it will not really look around but metaphorically look around for a state of RAS activation. If the cell is not in a state of RAS activation then the virus won`t replicate. If the cell is RAS activatived it will replicate. RAS activation is very common in cancer cells and and not present in normal cells. So you get a differentiation in cell replication based just on that metabolic state. Now the RAS pathway is a cell signalling growth pathway. Cells don`t divide unless they are told to normally and so if you are a normal cell there is usually an extrinsic signal delivered to the surface of the cell that tells the cell to divide and you have a single division event. And that`s just normal thats a normal cell. Along that pathway is a protein called RAS and so that entire pathway has come to be called the RAS pathway . And that pathway can be turned on by a normal signalling event or it can be turned on by changes in that pathway that lead it to be turned on all the time. And that can be mutations at the surface and surface proteins that signal through RAS eventually It can occur because of changes in RAS itself. Or it can actually occur through phenotypic variations. But there numerous molecules that cause that particular pathway to be turned on. And some of these are quite topical in cancer research today like EGFR and and the non-tyrosene kinase group and those sorts of thing. They all signal through RAS ???signals through RAS when it is turned on.

This metabolic state (activated RAS) is probably the most common metabolic state found in cancer. A conservative estimate is about 2/3 of all cancers are RAS-activated. And this translates into a patient population, if you start to look at it that way, in Western Europe, the United States, and Japan, of over 4 million patients a year that have this particular cause of cancer. This will vary however from cancer to cancer. What we think of as more aggressive primary tumors, things like pancreatic cancer, glioblastoma (which is the most aggressive form of brain cancer) melanomas, those sorts of cancers all have a very very high RAS-activation rate - well up into the 90s in percentile. The most common cancers that people tend to think of, like prostate, non-small-cell lung, ovarian, breast, are all in the two-thirds to 70% range and that`s what drives that average to that number. Recently it`s been commented that most or all metastatic disease is probably due to RAS-activation and that`s certainly an area of intense interest to us as metastatic disease is not well treated today and not well studied. So a therapeutic that could treat metastatic disease certainly would be of benefit.

We know how this virus works. The virus will enter as I said all cells it enters primarily through a silacic acid residue. Thats just a sugar receptor? thats found on the surface of almost all cells. The virus uncoats and if its just anormal cell and not RAS activation the interferon pathway is still active and the virus is pretty much shut down. The native habitat of the virus is thought to be the cells lining your lung or your bowel.and they are in a sort of pseudo-RAS activated state. They are bathed in epidermal growth factor and are sort of RAS activated and the virus is thought to grow in those cells in the native enveironment. Those slough and die every twenty four hours anyway so you don`t see any pathology. And thats why you don`t see any pathology when the virus infects those cells. But when it enters into a cancerous cell with activated RAS it will undergo a complete replication event in around thirty six hours the cell will of an apoptotic cell death and you will get up to twenty thousand viral progeny spreading to surrounding cells. And so you get this cycle of infection, replication, cell death, re-infection until the virus can`t find any more cells to infect that will support replication.

An important element of area is looking at intellectual property. We are fortunate that this particular virus came out a virology lab and not an oncology lab and as a result the IP area was relatively open when we started looking in this area. We now have eleven US patents issued and about thirty different families of patent filings behind that. To date I think we`ve been fortunate to get the kind of claims that one would typically want to see. We have composition of matter claims, pharmeceutical use claims, manufacturing claims, and a variety of combination therapies with existing chemotheraputics. Surgery and radiation which are going to become very important. We also have patents in the area of some other viruses including adenovirus and herpes virus claims that have been genetically engineered to target the RAS pathway. This is an ongoing activity for us. Our goal is to insure that we have a self-renewing patent base going well into the future and certainly beyond hopeful product approval.[/b]

An element in biologics that is increasingly important is manufacturing. And people often tend not to talk about manufacturing in biologics. That`s generally because there are problems. There always seems to be a difficulty in manufacturing. Many products today in biologics get turned down in approval stage not because the clinical studies don`t work but because teh manufacturing process isn`t reproduceable, or high enough yield, or a variety of other factors.

We`ve been fortunate in that we`ve been using a naturally occuring virus. They tend to be easier to manufacture than genetically engineered viruses. But some people have hade success at using genetically engineered viruses in manufacturing. We`ve successfully completed a process that should be scaleable and based on our conversations with the FDA we believe should meet the regulatory requirements that will be required in the United States. And we`ve actually transfered this from one clinical production group to another clinical production group now, which is important. The ability to transfer a process is really the acid test of whether it`s a robust process. Our current manufacturer, BioReliance, is in the process of transfering this process from the United States to the UK, and we have a second supplier, Cobra Biomanufacturing in the United Kingdom, that we`ve brought on. So we are quite pleased that we have a process that appears to be robust and scaleable and actually have product on the self today to support our clinical programs for 2005.

Looking at clinical development. I find that occasionally, from an historical perspective, and to remind ourselves of what we`re looking for in the clinic to go back and look at animal models.

This is a picture of an immune competent mouse (a mouse with an intact immune system) that`s had a mouse tumor implanted on it. This isn`t a xenograft, it`s a mouse tumor on a mouse. And we can do this with the reovirus because the reovirus is a mammalian virus, not (just) a human virus. So it`s been very predictive to date to look at the virus` activity in the animal and it`s been a very good match-up with what`s happened actually in humans from a safety and clinical perspective. What`s important about this picture, I think, is two things: 1. The animal on the left obviously was not treated with reovirus and you`ll see, more importantly than the tumor, the general wasting that you associate with cancer and a very large lesion on it`s left hind flank. The animal on the right was treated I believe in this case with a single injection of the virus intratumorally. But you can do it intravenously and it works the same way, or spray it as a mist into the lungs for lung models and the virus is very adaptable. The animal is sleek, it`s plump, it`s fur is intact, and it actually has bite marks where it has been engaged in normal mating and other types of behavior with other animals. Here`s a key thing with the tumor down in the corner (it`s a little difficult to see this picture). There`s a little nodule left over, and this is a characteristic of this kind of therapy. What we found both in animals and in humans is that after treatment, because the virus is so selective, there`s always something left over that one might think is a tumor, but indeed is not a tumor - it`s left over connective tissue. The virus is so selective that it will literally take cancer cell inbetwixt and between supportive tissues and leave the supportive tissues healthy and surrounding?. We`ll get this little nodule pretty much in animals and in humans. It`s kind of an interesting thing to look for.

Compare that (it`s a little difficult to see in this slide) with a patient from our very first original phase 1 study. It`s a female patient with a head/neck cancer on the back over her neck (just on the left side of her nape hair there) and that red mark in the middle is actually where a punch biopsy was, not where the virus was injected. This was an intratumoral administration at the second lowest dose of this study (this was a dose escallation study). And again we see the same characteristics - we see (this tumor was graded actually as a partial response - the tumor flattened out completely) again we don`t see loss of hair, we don`t see tissue disruption around the injection site and we have a lump left over that never grew back - it was completely stable disease and we believe it was again just connective tissue and tissue that is left over after the virus has done its job. It`s kind of nice to historically take a look at animals and to see how those effects actually translate into human beings.

Our clinical program right now is actually split into three parallel programs. First is looking at systemic delivery of the virus as a mono-therapy in metastatic disease and primary tumours. I`ll talk about that briefly. We are continuing on with our local administration program where we are using the virus as a mono-therapy , in this particular case for glioblastoma. And increasingly our focus is on looking at reovirus in combination with existing chemotheraputicsand radiation, because the reality is that in oncology very few mono-therapies are used as mono-therapies when they start. They are used in combination therapies, so it is important for us to understand with existing therapies.

This is just a chart to show the progress flow that we`ve been following. We originally did a phase 1 intratomoural study which I`ll be talking about. The safety data and tumour regressions we saw there enabled us to move into a more agressive intratumoural study which is direct injection into the brain for glioblastoma. And into a deep tumour study - a very short one - for T2 prostate cancer. Again the data from the T2 prostate study, as I`ll be showing you, allowed us to go into systemic studies and our early suystemic data will allow us to go into combination therapystudies.

Our very first study was an intratumoural dose escalation study. And dose escallation in this area always brings a smile to the face of anyone in this area because you have a self-reproducing drug. So whether you inject 10^7, 10^8, 10^9, or 10^10 viruses (which is a big range) into a tumour you a couple of days later you will probably have 10^12 or 10^13 viruses floating around. In intratumoural studies pretty much every dose is a theraputic dose as it turns out. In this particular study, we didn`t have any severe adverse events or dose limiting toxicology.
And just as a note, with this area, out of the hundreds of gene therapy studies that have been done and now dozens of oncology studies that have been done with viruses from a half a dozen different species of virus - so we are probably talking four or five thousand patients - there have been less than ten severe adverse events for that entire group - for all those different studies and different viruses. This is probably one of the safest, or the safest theraputic area under investigation, certainly that I`m aware of. And I think that the group as an area has really focused a lot on safety and that`s shown in the results that we`ve got to date as a group.
We are quite pleased in this patient population. This patient population had failed a median of two chemotherapies, most had failed surgery, most had failed radiotherapy. We actually detected regressions of greater than thirty percent two dimensional which is roughly fifty percent three dimensionally in around two thirds of the patients - eleven of the eighteen. Those ranged from thirty two percent to one hundred percent regression. the hundred percent ones were a bit of a surprise to us because as I told you earlier that there isconnective tissue you usually have a nodule left over. We were interested to se a hundred percent regression. We also saw the virus spread from tumour to tumour. So if you injected into ione tumour a tumour that was not congruent with that tumour would also shrink in some cases, which was important for our systemic studies..

From there we went to a small T2 prostate study. T2 cancer is prostate cancer that hasn`t metastized yet, so it`s still localized in one or the other of the lobes of the prostrate gland. The purpose of this study, the end point, was histopathology. We wanted to show on slides from reproduceable tissue sample, which is a gland, that we actually could show a specific type of tumor death (apoptotic cell death) side by side with tissue that was unaffected. And we actually have that evidence now. There`s six patients - it was a small study - we had absolutely no evidence of effect on the surrounding tissue at all, very selective for the tumor tissue. Four of the patients actually have the type of cell death we were looking for, which is apoptosis, which is the official endpoint. Surprising to us because of the method with which we treated, one injection at a low dose, we didn`t expect to come up with clinical outcomes. One of the patients actually had a clinical outcome. The gland went back to normal and the PSA levels went back to normal. And we also had some evidence of what we call selective immune cell infiltration in the tumor. There`s a number of interesting immune responses associated with this specific viral therapy which we are currently investigating.

Ongoing from there we moved into a phase 1-2 malignant glioma study. The patients we are running in canada have had multiple recurreances of GBM and have life expectancies of three months. The first part of the study (which is still ongoing) is looking at safety first and when we move into the phase 2 part of the component we will look at efficacy as the first endpoint. Reports reported to date show that there haven`t been any severe adverse events, or dose limiting toxicologies, and absolutely no evidence for example of encephalitis, both clinically and now from pathology from debulked tumors.
Now we are actually treating patients systemically and there are a variety of reasons why it is important for people with viral therapies to move into systemic treatment. Certainly it`s the largest patient population. Probably 80% of that 4 million patients plus I mentioned earlier treatable with this particular therapeutic are only accessible through systemic administration. They either have tumors that are not ammenable to direct therapy, or they have metastatic disease which is obviously not ammenable to direct injection. What we found is the product is well tolerated at all the dosage levels using, unfortunately, primates, cannines, and rodents. And that`s very aggressive therapy. That`s 28 daily infusions of very high dosages of the virus. What you are looking for in daily infusions is things like spiking fevers, as a result of cytokine cascades, and those sorts of things which have been noted in other viruses, but we have not seen that at all in any of our animals. We have very strong pre-clinical evidence that you can actually treat systemically with the virus, both metastatic disease and primary tumors. And as I mentioned earlier we had indications in our initial phase 1 trial that the virus is spreading systemically, which is important.

We are currently undergoing a phase 1 component of a systemic administration study at the Royal-Marsden Hospital in the United Kingdom. Starting next month we`ve initiated a second site at St. George`s Hospital they`ll start enrolement in October. The purpose of having two sites in the UK is to allow us to expand the usage base out of a smaller group of oncologists to a larger group, and you get a broader number of indications. The different hospitals have different populations and indication bases. Our study is a dose escallation study for up to 40 patients IV. And we are looking of course at maximum tolerated dose and DLT and safetly and we`re also monitoring immune status very closely and looking at tumor responses. Its early on in this study, as of today we haven`t seen any severe adverse events and we have not reached a dose limiting toxicology as of yet.

Late last year we announced an agreement with the National Cancer Institute and they`ll be providing clinical support for a number of studies for us here in the United States. We`ll provide the product and they will pay for and run the studies. Their focus is really a very practical focus, which you expect out of the NCI. They`ll look at how the product will actually be used . So we`ll be working with the NCI to file those studies in the near future and we`ll be primarily looking at the virus under combination with existing therapies - probably chemo and radiation.

Now its interesting, you can take what you learned in the clinic and go back into the lab and actually expand your indications further. So we have a very iterative program where we take our clinical experience and go back and expand the uses of things. One of those is to look at other viruses and modify them to actually exploit this RAS pathway that we`ve talked about. Most other viruses don`t utilize the RAS pathway but if you genetically engineer adenovirus and herpes virus as an example and some other ones as well. You could actually make them selective for RAS active cells. Since they are different viruses we believe there may be certain advantages to using different viruses for different indications or different targeting. So we are working with Dr. Alamay in Barcelona and he is coming up with a clinical candidate for us using modified adenovirus that target RAS pathway.

In addition, we are also looking at the use of the virus in combination with chemotherapeutics and with radiation. The initial indications that the virus may be a radio-sensitization agent - in our phase 1 study where we had patients who had failed radiotherapy, were subsequently treated with reovirus and then retreated with radiation after - they had dramatic tumour responses that went way beyond what you`d expect from the virus and the radiation alone. Again, we`ve taken that experience and gone back into the lab and are a good way through the basic research process of taking a look at the parameters that define that combination. It does however appear that Reolysin is actually a very potent radio-sensitizing agent and, interestingly enough, it looks like it is a very selective radio-sensitizing agent which is a major issue with radiation. Sensitization usually sensitizes everything, not just the cancer you are looking at. But we are certainly still working on that.

We`re also looking at chemo combination. We had a historical ??? published on this that the virus works quite well with Cisplatin. But we`ve expanded that through collaboration and we`ve looked at other products. Again, this is an animal model and in the lab, and we`ve found that it`s either additive or super-additive with a number of agents. It includes (this is not a complete list) things like 5FU, Gemcitibene , the platin group, and doxorubesin (sp?). Interestingly enough, as predicted (which is unusual in our business), we found that it wasn`t additive with the Taxol group. That was actually predicted based on the mode of action of Taxol which actually reduces viral replication. Occassionally it`s nice to have something that actually is predictable in this area, because people know in oncology it`s rarely that way. These findings and the radio-sensitization findings are being integrated into our future clinical program for co-therapy studies.

Just with respect to our market and capital data, we trade both on the Toronto stock exchange and NASDAQ. Our June 30 numbers, just under thirty million shares basic and thirty five plus million shares fully diluted and we had cash equivalents at that period of time of a little over twenty five million Canadian which at our anticipated burn rate takes us into early 2007.

[muycaro]

Hier nochmal der Link zum Transscript im Stockhouse Board (da ist die Schrift etwas grösser = angenehmer zu lesen):

http://www.stockhouse.ca/bullboards/viewmessage.asp?no=83763…

[Dr.Aljechin]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[muycaro]

Hallo!

Das kann ich Dir leider auch nicht genau sagen, bzw. denke ich dass es noch gar nicht feststeht.
Das AGM sollte jedoch wieder im Mai stattfinden (dieses Jahr war es am 26.) und wie immer in einem Kongresszentrum in Calgary.
Ich denke der genaue Termin wird irgendwann Anfang nächsten Jahres bekannt gegeben werden. Falls jemand anders schon Informationen hat, kann er ja posten.

Ansonsten einfach mal den IR mailen:

[e-mail]

Cathy Ward antwortet meist sehr schnell (innerhalb weniger Stunden).

Viele Grüsse und ein schönes Wochenende.

[muycaro]

Vom Yahoo Board (nächste Termine):

Upcoming Events
by: kz7m2003
Long-Term Sentiment: Strong Buy 09/17/04 11:50 pm
Msg: 27234 of 27236

From Stockhouse


We actually have four. to look forward to.

September 28th Dr Scott Wadler will be presenting at the EORTC in Sweden re
Reolysin and Chemo/ Radiation (combination therapy)

October 7th Brad Thompson will present a corporate overview of Oncolytics Biotech
and Wayne Schnarr will act as a concultant at the BIO CONTACT conference in
Quebec

October 26-28th Rodman and Renshaw 6th annual healthcare conference in New
York

November8-10th Bio Partnering conference in Cologne Germany

P.S.
We also may soon have a formal announcement about the initiation of clinical trials at
the St Georges Hospital in the UK.
And I have a hunch that we may also hear something about the initiation of
combination trials with the NCI just prior to Dr Wadlers presentation on
September28th. We`ll see. Anyhow there is a lot happening in the next couple of
months.



Wird wohl ein heisser Herbst mit vier Konferenzen innerhalb der nächsten acht Wochen.

Sollte dann tatsächlich noch nächsten Monat die intravenöse Phase I in England auf das St. George`s Hospital ausgeweitet und der Beginn der Versuchsreihen in Kooperation mit dem US National Cancer Institute "NCI" bekanngegeben werden sollen...

Wir haben wohl endlich den (im Biotechbereich immer ziemlich toten) Sommer überstanden...

Viel Glück allen, die ONCY halten, und allen anderen natürlich auch.

[muycaro]

Interessant: Unabhängige in vivo Studie, die die Wirksamkeit des Reovirus (bzw. Reolysin = Reovirus Typ 3) als Therapie gegen Brustkrebs suggeriert:

SUBJECT: Reovirus effective in breast cancer - new Posted By: whosyurdaddy
Post Time: 9/17/04 09:40
« Previous Message Next Message »

From PubMed
Gene Ther. 2004 Sep 16 [Epub ahead of print] Related Articles, Links

Reovirus as an experimental therapeutic for brain and leptomeningeal metastases from breast cancer.

Yang WQ, Senger DL, Lun XQ, Muzik H, Shi ZQ, Dyck RH, Norman K, Brasher PM, Rewcastle NB, George D, Stewart D, Lee PW, Forsyth PA.

1Departments of Oncology and Clinical Neurosciences, University of Calgary, Tom Baker Cancer Centre, Calgary, Alberta, Canada.

Brain and leptomeningeal metastases are common in breast cancer patients and our current treatments are ineffective. Reovirus type 3 is a replication competent, naturally occurring virus that usurps the activated Ras-signaling pathway (or an element thereof) of tumor cells and lyses them but leaves normal cells relatively unaffected. In this study we evaluated reovirus as an experimental therapeutic in models of central nervous system (CNS) metastasis from breast cancer. We found all breast cancer cell lines tested were susceptible to reovirus, with >50% of these cells lysed within 72 h of infection. In vivo neurotoxicity studies showed only mild local inflammation at the injection site and mild communicating hydrocephalus with neither diffuse encephalitis nor behavioral abnormalities at the therapeutically effective dose of reovirus (intracranial) (ie 10(7) plaque-forming units) or one dose level higher.

In vivo, a single intratumoral administration of reovirus significantly reduced the size of tumors established from two human breast cancer cell lines and significantly prolonged survival.

Intrathecal administration of reovirus also remarkably prolonged survival in an immunocompetent racine model of leptomeningeal metastases.

These data suggest that the evaluation of reovirus as an experimental therapeutic for CNS metastases from breast cancer is warranted.

Gene Therapy advance online publication, 16 September 2004; doi:10.1038/sj.gt.3302319

PMID: 15372068 [PubMed - as supplied by publisher]

http://www.stockhouse.com/bullboards/viewmessage.asp?no=8394…

[muycaro]

Aktuelle Shortposition an der TSE (Toronto Stock Exchang/Kanada):

Short History for ONC
Symbol Exch Report Date Volume Change
ONC T 2004-09-15 659,679 64,100
ONC T 2004-08-31 595,579 201,400
ONC T 2004-08-15 394,179 -10,400
ONC T 2004-07-31 404,579 -113,258
ONC T 2004-07-15 517,837 -83,500
ONC T 2004-06-30 601,337 2,800
ONC T 2004-06-15 598,537 -10,600
ONC T 2004-05-31 609,137 -25,864
ONC T 2004-05-15 635,001 9,064
ONC T 2004-04-30 625,937 -41,900
ONC T 2004-04-15 667,837 104,782
ONC T 2004-03-31 563,055 220,414
ONC T 2004-03-15 342,641 49,675
ONC T 2004-02-29 292,966 12,036
ONC T 2004-02-15 280,930 29,383
ONC T 2004-01-31 251,547 39,810
ONC T 2004-01-15 211,737 27,700
ONC T 2003-12-31 184,037 13,500


Kleine Postsammlung von Stockhouse:


SUBJECT: RE: Just a few more weeks..could it be glio news? Posted By: BSspiral
Post Time: 9/22/04 10:52
« Previous Message Next Message »

I wonder.
The whole glio trial/NR process seems to have been odd.

From the outset, the enthusiasm of Dr. Forsyth has been unmistakable. Pre-clinical data showed remarkable results, and Dr. Forsyth commented that he had never seen anything like it.

Early NR`s indicated that patients had survived well beyond the expectations of their doctors, with four of six patients surviving 7 to 10 months past treatment (one of those 4 patients apparently subsequently died after failing to stay on convulsion medication, which had nothing to do with the treatment itself).

That ratio of `efficacy` seems to be very unusual within a random group of glio patients participating in a Phase I trial.

Then, the protocol was changed to enchance `safety` and `efficacy` measurements, and no more NR`s or updates. athough subsequent comments from BT lead to the belief that patients continued to survive for extended periods of time (some of the eary patients apparently well past 24 months at last count, almost a year ago).

Efficacy isn`t usually an endpoint, secondary or otherwise in Phase I or Phase II trials.

So, what was the protocol change really all about?

And why does it seem that ONC has quite pressing for US glio trials?

In the meantime, amid other things going on, BT commented that he expected to be able to release stunning soon.

That comment was prior to the NCI announcement and the Marsden announcement. Those announcements were interesting and perhaps even exciting, but stunning? Not really.

So was BT really referring to the glio trial?

I wonder if the Canadian regulations have provisions similar to the FDA regulations that allow any trial to become pivotal?

Do the Candian regulations have provisions similar to the US regulations that provide for an advance agreement that marketing approval may be granted if endpoints are met in the current trial?

I don`t know, but if such provisions exist in Canada`s regulations, I wonder if the current glio trial are leading to early approval of REOLYSIN in Canada, with or without an extension of the current trial?

Now that would be truly stunning, and imo, it is also entirely possible!


_____________________________________________________


SUBJECT: BSspiral Re: OT (Priority review) Posted By: BearVsBull
Post Time: 9/22/04 22:16
« Previous Message Next Message »

Recently Health Canada granted priority review to Antogren (for MS).
"For the first time in MS, Health Canada has agreed to give priority review to a treatment based on one-year trial data", said Dr. Paul O`Connor, neurologist and director of the St. Michael`s Hospital MS Clinic in Toronto.

Serveral criteria are needed for a drug to receive an accelerated review by Health Canada. The criteria include providing a statistically significant and clinically relevant impovement in efficacy or safety over existing therapies, be intended for patient suffering from a serious, life-threatening or severely debilitating condition and be indicated to treat, prevent or diagnose a serious symptom or manifestation of the condition.

Source: Calgary Herald, Friday September 10, 2004, page B11, MS drug clears first hurdle by Mario Toneguzzi.

BvB

_______________________________________________________


Liste mit interessanten Links zu Oncolytics, Reolysin, Patenten, Versuchsreihen, unabhängigen Studien, etc.:


Efficacy reports from phase 1 glio trial
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d…

Systemic Administration animation
http://www.oncolyticsbiotech.com/webfiles/moviewindowQuickTi…

Onc`s FAQ
http://www.integratir.com/faq.asp?ticker=t.onc&title=null

Marsden trial NR
http://www.biologicalprocedures.com/bpo/general/news/040301/…

Reports from the trial so far
http://www.vcall.com/CEPage.asp?ID=89062

Before and After Tumour Pictures
http://www.oncolyticsbiotech.com/clinical.html#Phase1

Video of the people behind it
http://b-tv.com/i/videos/Oncoliytes300kbs.wmv

Beat Cancer Now, Easy to follow overview of everything
http://www.beatcancernow.com/

Patent Base
http://www.integratir.com/custommessage.asp?ticker=t.onc&mes…

http://v3.espacenet.com/results?sf=a&FIRST=1&CY=ep&LG=de&DB=…
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=H…

http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=…

Recent Equicom Report
http://www.equicomgroup.com/profiles/ONC-profile.pdf

40-F sec filing Company Background etc
http://www.integratir.com/cfiling.asp?theurl=filing%2Ephp%3F…

FDA speeding up approvals
http://www.msnbc.msn.com/id/5446110/

Clinical Trials Page
http://www.oncolyticsbiotech.com/clinical.html

NCI Collaboration Release
http://www.integratir.com/newsrelease.asp?news=2294427&ticke…

Third Party Validation
http://www.integratir.com/custommessage.asp?ticker=t.onc&mes…

How it works and more third party validation
Articles on the Mechanism of Selectivity and Oncolysis:
http://finance.messages.yahoo.com/bbs?.mm=FN&board=160078146…

Articles on Effectiveness:
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

21st Century Research Note:
http://www.stockhouse.ca/bullboards/viewmessage.asp?no=63328…

Potential Share Price Calculator:
http://www.canadiantreeplanting.com/onc_share_price.html

Webreader for Reovirus Research:
http://www.webreader.net/

[muycaro]

Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Inc.`s Research Collaborators Present Data on the Enhancement of the Cytotoxicity of Cancer Drugs by REOLYSIN(R)
Tuesday September 28, 3:00 am ET


CALGARY, Sept. 28 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX: ONC, NASDAQ: ONCY) announced today that a poster will be presented on September 30, 2004 at the 16th EORTC-NCI-AACR 2004 Symposium on `Molecular Targets and Cancer Therapeutics` in Geneva, Switzerland entitled "The oncolytic reovirus, Reolysin, augments the anticancer effects of cytotoxic agents in vitro against the ras-mutated human colon cancer cell line HCT 116." The researchers were able to show that REOLYSIN® enhances the cytotoxicity of chemotherapeutic agents including 5-FU, gemcitabine, doxorubicin and cisplatin.


"This research demonstrates that REOLYSIN® may enhance the cytotoxicity of several drugs that are widely used in cancer treatment," said Dr. Matt Coffey, Oncolytics` Vice President of Product Development. "We will use this positive data in designing future clinical trials."

The abstract is available at http://ex2.excerptamedica.com/ciw-04ena/index.cfm. The EORTC-NCI-AACR symposium is held on an annual basis and is jointly organized by the European Organization for Research and Treatment of Cancer (EORTC), the US National Cancer Institute (NCI) and the American Association for Cancer Research (AACR).

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

This news release contains forward looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements, including the Company`s belief as to the use of the human reovirus alone or in combination with certain chemotherapeutics as a potential cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the efficacy of REOLYSIN® alone or in combination with certain chemotherapeutics as a cancer treatment, the success and timely completion of clinical studies and trials, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward looking statements. The Company does not undertake to update these forward looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/prnews/040928/to292_1.html

[muycaro]

Hier noch das in der Meldung erwähnte abstract:

Abstract 452:

The oncolytic reovirus, Reolysin, augments the anticancer effects of cytotoxic agents in vitro against the ras-mutated human colon cancer cell line HCT116

Citation: European Journal of Cancer Supplements Volume 2, No.8, September 2004, page 135

S. Wadler1, B. Yu1, M. Lane1, L. Klampfer2, T. Sasazuki3, S. Shirasawa3, M. Coffey4

1Weill Medical College of Cornell University, Hematology & Medical Oncology, New York, NY, USA
2Albert Einstein College of Medicine, Oncology, Bronx, NY, USA
3Kyushu University, Fukuoka, Japan
4Oncolytics, Calgary, Canada

The type 3 reovirus, Reolysin, is an oncolytic virus with selectivity for ras-activated cells both in vitro and in vivo. In order to better define the activity of Reolysin in vitro and specifically to study interactions between Reolysin and cytotoxic agents, cell proliferation studies were undertaken in HCT116 cells. Reolysin was highly cytopathic against HCT116 with 60% reduction in cell number at doses as low as 1×10-5 pfu and nearly 100% at doses of 0.1 pfu at 7 days exposure. With as little as 2 days of exposure to virus, there was 50% cytotoxicity with doses of 1 pfu. Of interest, Reolysin was equally active against cells that were 80% confluent or at confluence as low as 50%. Despite enhanced cytotoxic activity in ras-mutated cells, previous studies have also demonstrated enhancement of activity in cells with a disrupted ras pathway. In order to test this hypothesis, we studied HCT116 variants in which ras was disrupted by homologous recombination. Of interest, these cells demonstrated equivalent sensitivity to Reolysin on days 2­7 and at doses of 1x 10-4 to 10 pfu. To determine whether Reolysin augmented the effects of various cytotoxic agents, cells were exposed to cytotoxic agents for 3 days with or without Reolysin, 0.1 pfu. The reovirus enhanced the cytopathic effects of fluorouracil at every concentration tested. Similar effects were observed with gemcitabine. Enhancement of the cytotoxicity of doxorubicin and cisplatin was observed, but only at concentrations approaching the IC50 for these agents. No synergy was observed with paclitaxel. Reolysin has in vitro activity against ras-mutated HCT116 and its ras-disrupted variant, and enhanced the cytotoxicity of fluorouracil, gemcitabine, doxorubicin and cisplatin against HCT116, making it a promising agent for clinical trials.

[muycaro]

Zweite Pressemitteilung von heute:

Press Release Source: Oncolytics Biotech Inc.; National Biotechnology Week


Oncolytics Biotech Inc. Supports National Biotechnology Week
Tuesday September 28, 1:05 pm ET


CALGARY, Sept. 28 /CNW/ - Oncolytics Biotech Inc. is pleased to be a supporter of National Biotechnology Week, Sept. 27 - Oct. 1, 2004. National Biotechnology Week is a creation of BIOTECanada, in collaboration with a variety of partners from the Canadian research and innovation community. The week is designed as a national program to showcase, educate and inform Canadian decision makers about the success and potential biotechnology offers to our quality of life.
Oncolytics Biotech Inc. was established in 1998 to develop the reovirus, or REOLYSIN(R) as a potential cancer treatment.

In 1998, researchers discovered that the reovirus had the ability to kill up to two-thirds of all human cancer cells. Investigation revealed that the reovirus could grow only in cells with a common set of mutations that result in an activated Ras pathway. The Ras pathway is instrumental in transferring growth signals to the nucleus of a cell, telling the cell when and how to grow and divide - much like an "on-off" switch. A cell with an activated Ras pathway has lost its ability to turn off the growth signal, leading to uncontrolled cell growth. An activated Ras pathway is evident in approximately two-thirds of all human cancers.

When the reovirus is introduced to the body, it infects both normal cells and cancer cells. In Ras-activated cancer cells, the reovirus multiplies in and subsequently kills the tumor cell. When the cancer cell dies, thousands of progeny viruses are freed, which then proceed to infect and kill adjacent cancer cells. In cells without an activated Ras pathway, antiviral proteins quickly neutralize the virus, without harm to the normal cell.

Oncolytics has successfully completed two human clinical studies with REOLYSIN(R) in Canada, and is currently conducting two additional studies: a Phase I intravenous administration trial with REOLYSIN(R) at two sites in the United Kingdom, and a malignant brain tumour trial in Canada. The company is also collaborating with the U.S. National Cancer Institute to conduct multiple clinical trials in the U.S.

Results to date indicate that REOLYSIN(R) is well tolerated with no side effects of note.

For more information on National Biotechnology Week, please go to www.biotechweek.ca. For more information about BIOTECanada, the voice of the biotechnology industry in Canada, please visit www.biotech.ca.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN(R), its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN(R) was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN(R).



http://www.newswire.ca/en/releases/orgDisplay.cgi?okey=20382
http://www.newswire.ca/en/releases/orgDisplay.cgi?okey=56839

For further information

For Canada: Oncolytics Biotech Inc., Cathy Ward, 210, 1167 Kensington Cr NW, Calgary, Alberta, T2N 1X7, Tel: [phone], Fax: [phone], [e-mail], www.oncolyticsbiotech.com
For Canada: The Equicom Group Inc., Joanna Longo, 20 Toronto Street, Toronto, Ontario, M5C 2B8, Tel: [phone] ext. 233, Fax: [phone], [e-mail]
For United States: The Investor Relations Group, Gino De Jesus or Dian Griesel, Ph.D., 11 Stone Street, 3rd Floor, New York, NY, 10004, T: [phone], F: [phone], [e-mail]



--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.; National Biotechnology Week


http://biz.yahoo.com/cnw/040928/oncolytics_biotech_wk_1.html

[muycaro]

Und als wär`s noch nicht genug, ein 21st Century Update (kopiert aus dem Yahoo Board):


by: retired_loveit (60/M)
Long-Term Sentiment: Strong Buy 09/28/04 03:19 pm
Msg: 27981 of 27989

21st Century: "Oncolytics continues to astound"

As if Oncolytics`s (ONCY) tumor-dissolving cancer treatment, Reolysin, weren`t amazing enough, now comes news that Reolysin enhances the anti-cancer activity of at least four anti-cancer agents, in vitro, against a ras-mutated human colon cancer cell line. Every time you turn around something else remarkable is happening with this drug. Share-price volatility is a guarantee for a while, but the stock is still a cautious buy now and on any backup. It`s trading this afternoon at $5.76, up from the re-entry price of $4.94 in the Aug. 23 "Update".

[muycaro]

http://www.barrons.com/:

Biotech licensing isn`t a brand new strategy for drug companies, but in the past, the big companies tended to wait until a biotech product had reached the second phase of human trials, or even the third and final phase. Each phase of testing involves more patients and more carefully designed experiments. Waiting for Phase III results was like drilling for oil in a gas station, jokes Pfizer strategist Rajiv Shukla.

There aren`t enough late-phase biotech candidates to satisfy the drug industry`s hunger, these days, so drug firms have been bidding for products in the earliest clinical trial phase -- and even in the preclinical laboratory phase.

Biotech firms with an immature product used to be happy to get a couple of million bucks up front and the promise of royalties, says Mark G. Edwards, the managing director of Recombinant Capital. Now, a growing crowd of drug-company bidders has enabled biotech firms to command up-front payments in excess of $50 million for licensing a product that is still in a Phase I clinical trial.

[r.schaui]

aus dem yahoo board ein artikel über onc

ONC Company Snapshot

BullBoards Member Forums My BullBoards
All Forum Search


Jump to ONC Forum


SUBJECT: RE: excellent summary... Reovirus and Cancer Posted By: whosyurdaddy
Post Time: 10/3/04 09:56
« Previous Message Next Message »

September 2004
Cancer and Terminal Illness

The reovirus acts directly on “Ras activated” cells

Is this the magic bullet?

Research suggests that a naturally occurring virus under development by Oncolytics Biotech Inc., called the reovirus selectively infects, replicates in and kills certain types of cancerous cells while leaving normal cells alone.

The reovirus is a naturally occurring oncolytic virus that is normally benign.

It is extremely stable in nature and it has remained virtually unchanged after millions of years of evolution. Recent discoveries have shown that cell defects which cause uncontrolled growth also make these same cells natural targets of this virus. The reovirus attacks and kills as many cancer cells as it can, leaving healthy cells untouched, before it is naturally cleaned out of the body by the immune system.

The reovirus, (respiratory enteric orphan virus) is a double stranded RNA virus that utilises a dependable enzyme called polymerase to replicate itself. Viruses consist of either ribonucleic acid (RNA) or deoxyribonucleic acid (DNA) and can be single-stranded or double-stranded. RNA/DNA is the primary genetic material found in all viruses. Because the reovirus is a double stranded RNA virus it is very stable and is less likely than other viruses to mutate. Viruses also require a specific type of enzyme that enables them to copy their RNA/DNA prior to replicating. Some enzymes are less stable than others, thus increasing the risk of mutation. The enzyme that the reovirus uses (polymerase) is amongst the most stable.

To understand how reovirus replicates inside a cell, we must have some understanding of a feature of all “eukaryotic” cells from yeast cells to all the cells in animals and humans. This feature, called “Ras activation”, controls much of what goes on in a cell. Think of Ras activation as controlling whether signals that touch the outside of a cell actually reach the nucleus of the cell to cause it to do things like divide or even die. Ras sits just on the inside edge of the cell surface and goes back and forth between an “on” state and an “off” state. Depending on conditions inside the cell, Ras controls the reaction of the cell to outside stimulus. Many cancerous cells have the Ras state stuck “on” all the time - hence the term “Ras activated”. Ras activated cells may be that way because of a mutation in the Ras gene or some other internal condition of the cell that causes Ras to get stuck in the “on” state.

To better understand the importance of Ras, consider the following: “In mammalian cells, Ras-activating stimuli include not only biological compounds such as growth factors and cytokines but also stress signals such as reactive oxygen species and UV radiation. In response to any of those stimulants, Ras activates an array of intracellular pathways through which it induces the appropriate biological response. This response is cell specific (eg proliferation in fibroblasts and differentiation in neuronal cells) and signal specific (mitogenesis in response to growth factors, growth arrest, and/or apoptosis in response to stress). In many cell types, constitutive activation of Ras leads to oncogenic transformation, which is manifested by unregulated proliferation, sensitivity to stresses, and loss of contact inhibition of growth.” (from Molecular and Cellular Biology, November 1999, p. 7529-7538, Vol. 19, No. 11).

A normal functioning cell produces a cellular protein called PKR that circulates throughout the cell. PKR destroys foreign particles, such as the reovirus. A Ras activated cell has a much lower production level of PKR, thus allowing the reovirus to inhabit the cell, divide indefinitely and ultimately kill the host cell. The progeny reoviruses then spread to other Ras activated cancerous cells and repeat this process. This process is believed to be repeated until there are no more Ras activated cells to invade. PKR and the immune system then eliminates the reovirus from the body.

The reovirus has the ability to replicate itself over 10,000 times in each host cell before freeing the progeny reoviruses to invade the surrounding cancer cells. At no time does the reovirus enter the nucleus of the host cell. This helps to ensure no unforeseen damage to the genetic material of the cell.

The reovirus causes no known disease, thus it is considered to be a safer alternative when compared to more conventional cancer treatments. Most people have already been exposed to the reovirus in a natural way and have never shown any symptoms of exposure. Recent testing in three species of animals have shown no significant side effects even at dosages as high as 10 times that which would normally be given to a human. Early stage human testing is showing similar high safety with few side effects. These tests also indicate the reovirus to be very effective in the treatment of cancer.

The reovirus is usually confined to the gastrointestinal or respiratory tracts in humans, so it would not have access to tumours growing elsewhere in the body, nor in the amount required to impact the tumours. This virus has not been associated with any known human diseases and is therefore considered to be non-pathogenic. Since it is considered such a “safe” virus, it has been used for decades by research institutions and individuals studying viral replication structure.

Extensive testing of the reovirus by a number of independent people have clearly shown significant cancer cell killing in the test tube, with normal cells not affected in any way. Animal studies have also shown substantial cancer killing effects, again with no significant side effects. Human studies now underway appear to be confirming that a reoviral treatment is very effective on different types of cancer.
Initial animal clinical trial results have indicated that there are no toxicology related issues with the administration of reovirus.

The trials involved 3 methods of administration.
1. Subcutaneous - Injection of the virus directly into a tumor under the skin of the animal;
2. Intravenous - Injection of the virus directly into the blood stream (systemic);
3. Intercerebral - Injection directly into the brain.

Results of a safety study using small primates were presented at The American Society of Gene Therapy’s annual meeting in Minneapolis, on June 6, 2004 by Ken Draper. The small primates were given daily intravenous infusions of reovirus each day for 28 days. Animals were grouped according to the dosage given them and evaluated at the end of the study. It was reported that the reovirus was well tolerated and no serious product related adverse events were observed.

A number of human studies are now underway or have been concluded. A study was made of 18 patients with a collection of different cancers where reovirus was injected directly into the tumor. A second study of early stage prostate cancer patients where the reovirus was injected directly into the prostate has recently been completed. A third study is underway of brain cancer patients where the reovirus was injected directly into the brain as a treatment for recurrent malignant glioma.

None of the studies have indicated any safety issues. The brain cancer study is a dose escalation study starting at lower dosages and going to higher dosages in later patients. No dose limiting toxicities were found.

Treatment with reovirus (trade name Reolysin) has demonstrated an extremely positive safety profile. Testing on both animals and humans indicate that reovirus is effective in the treatment of cancer.
Numerous published studies in science magazines from independent sources have confirmed that the reovirus infects, replicates within and kills Ras activated cancer cells but not normal cells.

From a 1978 study by Theiss JC, Stoner GD, Kniazeff AJ. (Natl Cancer Inst. 1978 Jul;61(1):131-4): “The effect of reovirus type 3 infection on the pulmonary adenoma response to urethan in strain A mice was examined. Urethan carcinogenesis in this system was suppressed from 30 to 60 per cent when mice were exposed to reovirus either 6 days before, on the same day as, or 14 days after urethan administration. These findings suggested that reovirus infection interfered with the progression of urethan-induced pulmonary adenoma rather than the induction of lung tumors by urethan.”

Numerous injections into different animal species showed no adverse affects of the virus, even at very high dosages. In somes case the results were startling:
“After a period of 12 days, the tumours had regressed significantly in six (80 per cent) of eight mice.” And “the reovirus killed 20 of 24 (83 per cent) of the established malignant glioma cell lines tested. It caused a dramatic and often complete tumour regression.”
There is also some evidence of remote activity whereby a tumour is injected and a second tumour somewhere else in the animal also shrinks.

Early results from a study of Reolysin in prostate cancer patients showed evidence of viral activity in five of six T2 prostate cancer patients without safety concerns. Preliminary data showed clear histopathological evidence of apoptic tumor cell death in four (66 per cent) of the six patients. In a fifth patient, the PSA level dropped by 53 per cent, and the prostate shrunk by 67 per cent”.

As the reovirus progresses through the clinical trail process its availability will increase.


r.schaui

[r.schaui]

und hierzu eine kurzzusammenfassung in deutsch:
ein natürlich vorkommender virus genannt reovirus greift krebszellen an und vernichtet sie. gesunde zellen werden vom reovirus nicht befallen. der reovirus kann sich in jeder gastzelle mehr als 10.000 mal reproduzieren.
versuche sowohl an menschen und tieren haben keinerlei nebeneffekte aufgezeigt.
der reovirus wurde wie folgt verabreicht:
- direkt in den tumor (unter die haut)
- in die blutbahn
- ins gehirn
folgende studien sind abgeschlossen:
- 18 patienten mit verschiedenen krebsarten, injektion direkt in den tumor
- patienten mit prostatakrebs mit injektion direkt in die prostata
- eine dritte studie mit patienten mit gehirntumor ist in arbeit wobei der reovirus direkt ins gehirn verabreicht wird
in allen bisher bekannten versuchen hat der reovirus eine erfolgsquote von 60 bis 80 % bis hin zur vollständigen vernichtung der krebszellen erzielt.

oncolytics wird wohl noch diese woche erste ergebnisse präsentieren.

mfg

r.schaui

[muycaro]

Hier nochmal der originale Link zu r.schauis geposteten Artikel: http://www.middleeastmedical.com/Articles.asp?Article=821 (hoffentlich werden wir nicht demnächst von irgendeinem Scheich aufgekauft...).

[muycaro]

Noch ein Post von Yahoo hinterher, der sich mit den Milestones für die nächsten Monate beschäftigt - was davon genau erreicht werden wird, weiss man nicht, allerdings zeigt der Beitrag diverse Möglichkeiten auf:

The next six months
by: rjc2827 10/03/04 10:13 pm
Msg: 28398 of 28403

There are lots of valid timeframes that can be selected in which to view the possibilities of what could happen in the progress of REOLYSIN toward being approved as a commercial therapeutic product in the treatment of a variety of cancers. I like a six month timeframe because it is long enough to have a chance at being a base for all that will follow, yet short enough to have a more speculative flavor.

Just to be clear; I’m assuming here that we will continue to see the clean safety profile that we’ve seen to this point (no severe adverse side effects), and I’m also assuming that the FDA conspiracy theories that we’ve heard of on this board are either just paranoia, or at least will become a non-issue.

Here are the events that I expect to see happen within the next six months. The first group (in my opinion, and presented without justification), represent those that I feel have a probability of occurring that exceeds 90%.

1. Approval of radiation/REOLYSIN co-therapy Trial in the UK
2. Approval of an FDA systemic Trial in the US
3. Approval of an FDA glio infusion Trial in the US
4. Approval of at least 2 of the expected NCI REOLYSIN co-therapy Trials

5. Release of preliminary results from the systemic Marsden Trial
6. Release of additional results from the Canadian glio Trial
7. Release of additional results from the pre-clinical studies being done by the NCI

8. Start of an FDA systemic Trial in the US (New York)
9. Start of an FDA glio infusion Trial in the US (Alabama)
10. Start of at least 2 of the expected NCI REOLYSIN co-therapy Trials

In addition I see the following occurrences as having a probability of greater than 50% of happening within the same 6 months:

11. Approval of more than 2 of the expected NCI REOLYSIN co-therapy Trials
12. Start of more than 2 of the expected NCI REOLYSIN co-therapy Trials

13. Coverage by one or more “brand name” US analysts.

And under the heading of possible, but with an unassigned probability, we have:

14. Additional manufacturing milestones achieved
15. Oncolytics “fast track” or “pivotal” announcement
16. Oncolytics partnership announcement

If you need a vacation, I wouldn’t take a full week off. Things could get pretty interesting around here.

rjc

[js200]

RAiDAR alerts Learn More About RAiDAR-LT


09/29/2004 (10:51 ET) ONCY: Volume Spike; 18% > 20-adsv, Stock +2.95% - Knobias



09/28/2004 (16:21 ET) ONCY: Jumps +5.17%; Vol +138%; Last 90 Min of Trading - Knobias



09/28/2004 (15:13 ET) ONCY: Filed 6-K Regarding Data Presentation-REOLYSIN(R) (Sep-28 PR) - Knobias



09/28/2004 (15:06 ET) ONCY: Filed New Form 6-K - Edgar



09/28/2004 (13:06 ET) Oncolytics Biotech Inc. Supports National Biotechnology Week - Canada NewsWire



09/28/2004 (08:34 ET) ONCY: Positive Data re Reolysin(R) to Be Presented at Conf. - Knobias



09/28/2004 (03:01 ET) Oncolytics Biotech Inc.`s Research Collaborators Present Data on the Enhancement of the Cytotoxicity of Cancer Drugs by REOLYSIN(R) - Canada NewsWire



09/28/2004 (03:00 ET) Oncolytics Biotech Inc.`s Research Collaborators Present Data on the Enhancement of the Cytotoxicity of Cancer Drugs by REOLYSIN(R) - PR Newswire



09/24/2004 (16:19 ET) ONCY: Short Interest DN 26.2% to 59.4K in Sep 2004 - Knobias



09/13/2004 (10:20 ET) ONCY: Volume Spike; 9% > 20-adsv, Stock -4.35% - Knobias



09/13/2004 (06:32 ET) ONCY: To Present At Wall Steet Analyst Conference @ 09:40 ET - Knobias



09/10/2004 (10:11 ET) ONCY: Volume Spike; 7% > 20-adsv, Stock +8.33% - Knobias



09/09/2004 (12:15 ET) ONCY: Filed 6-K Regarding Wall Street Analyst Forum (Sep-09 PR) - Knobias



09/09/2004 (12:13 ET) ONCY: Filed New Form 6-K - Edgar



09/09/2004 (11:51 ET) ONCY: Volume Spike; 22% > 20-adsv, Stock +3.68% - Knobias



09/09/2004 (08:32 ET) Media Advisory - Oncolytics Biotech Inc. to Present at the Wall Street Analyst Forum - Canada NewsWire



09/09/2004 (08:30 ET) Media Advisory - Oncolytics Biotech Inc. to Present at the Wall Street Analyst Forum - PR Newswire


JS200

[r.schaui]

From Yahoo Board Post Time: 10/7/04 14:33
Reolysin manufacturer up44% on +ve news
by: tonwalth (M/Devon, England.)

Cobra Biomanufacturing (CBF), the UK listed manufacturer of Reolysin was up 44% today on a positive update given to the market.

Included in the update was the following paragraph.reolysin is not mentioned specifically, but ONCY/reolysin is an important contract for Cobra. Might it be reasonable to think Reolysin production for on-going and forthcoming trials is part of the reason for the increased order book?

Here`s the paragraph:

`The Company`s confirmed forward order book for the current half year is more
than double the position at this time last year. The composition of this future
business reflects the refocusing of our sales effort towards virus and protein
orders following the shift in demand away from DNA as reported earlier this
year. Confirmed orders from the important North American market are improving,
supported by a number of initiatives including the appointment of a dedicated
salesperson based in San Francisco who is particularly experienced in protein
sales.`

mfg
r.schaui

[merx]

Da haben gestern wieder die MM ihr Spielchen getrieben.

Shacking the tree..........

Da heisst die Devise : einsammeln......

Big move is coming.


m e r x

[merx]

Press Release Source: Oncolytics Biotech


The Good Virus - Reovirus` New Role as Cancer Fighter
Tuesday October 19, 5:05 am ET


CALGARY, Calif., Oct. 19 /PRNewswire/ -- Viruses are undergoing an "extreme makeover" after a long-standing reputation as bothersome and in many cases, lethal to the human body. A virus named the Respiratory Enteric Orphan virus, or reovirus, has been discovered to have the ability to grow in and kill a broad range of cancer cells without growing in or damaging normal, non-cancerous cells.
ADVERTISEMENT


Oncolytics Biotech`s REOLYSIN®, an experimental, reovirus-based cancer therapy, is able to freely replicate in and kill the host tumor cell. When the cancer cell dies, thousands of progeny viruses are freed, which proceed to infect and kill adjacent cancer cells. This process is believed to continue until all adjacent cancer cells have been infected with the reovirus, according to Brad Thompson, CEO of Oncolytics Biotech. The reovirus cannot grow in healthy cells, therefore normal cells remain healthy.

"REOLYSIN targets these tumors directly and has been shown to be effective in various trials," says Thompson. Oncolytics has successfully completed two human clinical studies in Canada, and is currently conducting two additional trials: a Phase I intravenous administration trial with the reovirus at the Royal Marsden Hospital in the United Kingdom, and a direct injection brain tumor trial in Canada. Plans are underway for additional trials both in the U.K. and in the U.S.

The science behind the new therapy was discovered at the University of Calgary back in 1998 when researchers were studying how certain viruses grow and multiply. They determined that the reovirus needed an "activated Ras Pathway" in order to be able to grow in and subsequently kill the cancer cell.

The Ras Pathway is instrumental in transferring growth signals to the nucleus of a cell, telling the cell when and how to grow-much like an "on-off" switch. An activated Ras Pathway, which has lost its ability to "turn off," leads to uncontrolled cell growth. An activated Ras Pathway is found in approximately two-thirds of all human cancers.

As the population ages, cancer is expected to surpass cardiovascular disease as the leading cause of death. In fact, half of all men and one-third of all women will develop some form of cancer during their lifetimes. The American Cancer Society estimates that there are currently 8.9 million people in the United States with a history of cancer. For more information, log onto http://www.oncolyticsbiotech.com.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech

[muycaro]

Was ist denn das für eine komische Pressemitteilung. Habe die auch erstmal nirgendswo gefunden, nicht auf Oncolytics Website, nicht auf Yahoo und auch nich in meinen Email Alerts von Oncolytics. Später dann im Yahoo Board...
Ist eher sowas wie eine Zusammenfassung von Oncolytics Forschungen (keine neue Entwicklung die eine PR benötigen würde). Hmmm (ich bezweifle immer noch dass das direkt von ONCY kommt)...

http://biz.yahoo.com/prnews/041019/nyfnse10_1.html

[muycaro]

Sollte Oncolytics endlich aufgewacht sein und beschlossen haben, nachdem jetzt so ziemlich alles was geht in von ihnen in Patenten formuliert und abgesichert ist, mehr Öffentlichkeitsarbeit zu betreiben? Ist das der Anfang einer neuen ONCY-PR Ära (die PR ist auch relativ verständlich geschrieben was vor ein paar Monaten ja noch undenkbar(?) gewesen wäre)?

[r.schaui]

hallo muycaro,
die veröffentlichung ist sicher nicht nur vor dem hintergrund der abgesicherten patente zu sehen.

vielmehr glaube ich, dass die marsden ergebnisse und die anderen laufenden testreihen so gut sind, dass oncy selbst sich sicherer über den erfolg von reolysin ist.
ich denke, uns stehen aufregende wochen bevor
lets wait and see

mfg
r.schaui

[muycaro]

@rschaui

Schön wäre es und eine Möglichkeit - ich habe da aber noch meine Zweifel. Nachdem was ich gehört habe (IR) war es im wahrsten Sinne des Wortes eine "Pressemitteilung" - nämlich für die Presse/Medien bestimmt und nicht den Aktionär, der mit der Story eh schon soweit vertraut ist (sicher über die Wirksamkeit waren sie/wir sich/uns doch schon recht lange - nach den vorherigen Testergebnissen - man denke an die Glioblastoma Patienten, die nach ihrer Injektion plötzlich noch jahrelang lebten, obwohl das Gegenteil diagnostiziert war, etc.).

Es wäre schön sollten tatsächlich demnächst erste Ergebnisse aus den Versuchsreihen mit intravenöser Verabreichung in London bekannt gegeben werden, allerdings glaube ich das könnte eher im 1.-2. Quartal 2005 geschehen. Naja, wir werden sehen.

In Erwartung freudiger News,

muycaro

[r.schaui]

@muycaro
du hast wohl recht, eigentlich gab es nicht neues, lediglich eine zusammenfassung der bisher bekannten und nachlesbaren informationen
allerdings wird durch eine derartige pressemitteilung ein grösserer kreis an interessenten, instis usw erreicht
relativ neu ist auch, dass BT/onc auf roadshow geht,
m.E. spricht dies für eine offensivere vorgehensweise als bisher, vielleicht doch ausdruck wachsenden eigenen vertrauens
mfg
r.schaui

[muycaro]

Press Release Source: Oncolytics Biotech Inc.


Media Advisory - Oncolytics Biotech Inc. to Present at the Rodman & Renshaw Techvest 6th Annual Healthcare Conference
Thursday October 21, 8:34 am ET


CALGARY, Oct. 21 /PRNewswire-FirstCall/ - Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY), will present a corporate overview at the Rodman & Renshaw Techvest 6th Annual Healthcare Conference on Wednesday, October 27 at 3:50 P.M. (ET) to analysts, portfolio managers, investment bankers and other financial professionals. The event will be held at the Waldorf Astoria Hotel in New York City from October 26-28, 2004.

A live audio webcast of the presentation will be available at http://www.wsw.com/webcast/rrshq4/oncy/ or on the company`s website at http://www.oncolyticsbiotech.com.

It is recommended that listeners log on 15 minutes in advance of the presentation to register and download any necessary software. An audio replay will be available for 90 days following the presentation at http://www.wsw.com/webcast/rrshq4/oncy/.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolylics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

The webcast time is subject to change. This release and the presentation related thereto contain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control and which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or expectations implied by these forward-looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/prnews/041021/to129_1.html

[muycaro]

Killing cancer where it lives


(NAPSI)-A fascinating medical discovery was made in 1998 by researchers studying how certain viruses grow and multiply: a virus named the Respiratory Enteric Orphan virus, or reovirus, has the ability to grow in and kill a broad range of cancer cells without growing in or damaging normal, non-cancerous cells.

After further investigation, researchers determined that the reovirus needed an "activated Ras Pathway" in order to be able to grow in and subsequently kill the cancer cell. The Ras Pathway is instrumental in transferring growth signals to the nucleus of a cell, telling the cell when and how to grow-much like an "on-off" switch. An activated Ras Pathway, which has lost its ability to "turn off," leads to uncontrolled cell growth. An activated Ras Pathway is evident in approximately two-thirds of all human cancers.

In these Ras-activated cancer cells, reovirus is able to freely replicate and kill the host tumor cell. When the cancer cell dies, thousands of progeny viruses are freed, and proceed to infect and kill adjacent cancer cells. This process is believed to continue until all adjacent cancer cells have been infected with the reovirus. In cells without an activated Ras Pathway, the reovirus cannot grow, and normal cells remain healthy.

This discovery led to the formation of Oncolytics Biotech Inc., a company established to develop the reovirus, Reolysin™, as a potential treatment for cancer. Moving beyond early testing in cell cultures, through various tests in animals and into human clinical trials, Oncolytics is focused on answering these basic questions:

• Is it safe in humans?
• Can we make it in sufficient quantities and under approved conditions?
• Is it effective in treating various types of cancer?
Oncolytics has successfully completed two human clinical studies in Canada, and is currently conducting two additional trials: a Phase I intravenous administration trial with Reolysin at the Royal Marsden Hospital in the United Kingdom, and a brain tumor trial in Canada. Plans are underway for other trials both in the U.K. and in the U.S.

Results to date indicate that Reolysin is well tolerated with no side effects of note. Evidence of cancer-killing activity has been noted even while it is early to draw final conclusions.

As the population ages, cancer is expected to surpass cardiovascular disease as the leading cause of death. In fact, half of all men and one-third of all women will develop some form of cancer during their lifetimes. The American Cancer Society estimates that there are currently 8.9 million people in the United States with a history of cancer. Approximately 1.3 million people are expected to be diagnosed with cancer this year, and more than half a million are expected to die from the disease.

Oncolytics Biotech Inc. trades on the NASDAQ (ONCY) and in Canada on the Toronto Stock Exchange (ONC).
To learn more, visit www.oncolyticsbiotech.com.
An activated Ras Pathway is evident in approximately two-thirds of all human cancers.

http://www.thereviewnewspapers.com/W101404/page10.html

[muycaro]

Heute präsentiert Brad T., ONCYs CEO, in New York auf der Rodman & Renshaw Techvest 6th Annual Healthcare Conference - die Präsentation beginnt ca 10 Minuten vor Handelsschluss in den USA, d.h. ca. 21:50 Uhr Deutscher Zeit. Man kann sich hier mit einklinken (empfehlenswert ist es diese Seite ca. 10 Minuten vor Beginn der Präsentation zu öffnen, um zu sehen, dass auch alle nötigen Plugins auf dem Rechner installiert sind: http://www.wsw.com/webcast/rrshq4/oncy/

Ausserdem wurde gestern noch ein neues Patent (ONCYs 12. in den USA) in den USA offiziell zugelassen:



Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Inc. Announces Issuance of 12th U.S. Patent
Tuesday October 26, 8:37 am ET


CALGARY, Oct. 26 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) ("Oncolytics") has been granted U.S. Patent 6,808,916 entitled "Method of Extracting Virus From Cell Culture". Claims in this patent cover various methods of production and processing of the reovirus.
ADVERTISEMENT




"This patent further expands our portfolio of intellectual property," said Dr. Matt Coffey, Vice President, Product Development of Oncolytics. "This patent adds to previously issued patents regarding manufacturing of the reovirus."

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

This news release contains forward looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements, including among others, the Company`s belief as to the safety and efficacy of the reovirus, the Company`s expectations as to the potential applications of the patented technology and other statements relating to anticipated developments in the Company`s business and technologies, involve known and unknown risks and uncertainties that could cause the Company`s actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward looking statements. The Company does not undertake to update these forward looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/prnews/041026/to234_1.html

[muycaro]

Eine kleine Zusammenfassung der wichtigsten Punkte der Präsentation gestern.

Brad spoke today at the Rodman & Renshaw conference. Here are some
of the highlights for me.

With Brad mentioning that we`re into multi-treatment with some of the
systemic patients, and with our earlier understanding that re-
treatment would only be offered to patients that showed some benefit
from their initial treatment, we have some (more than one) of the
early (low dose) patients showing signs of efficacy. Sounds good to
me.

Anticipated burn rate gives cash availability to the end of Q1 2007.
Note: This is not just based on current burn rate, but on anticipated
burn rate.

According to Brad, we should expect to see the NCI co-therapy
clinical studies in 05. but there was also a mention of a radiation
co-therapy Trial coming up soon. I expect that this is the
anticipated UK Trial that I`m expecting to hear more about soon.

Although Brad said that it wasn`t Oncolytics` main focus at this time
(cancer is), he re-confirmed that the reovirus could also find
application in the treatment of neurofibromatosis and rheumatoid
arthritis. Although not mentioned by Brad today, I am aware that
these two named future applications are already covered under
existing (issued) Oncolytics` patents.

Brad spoke of the St George and Marsden facilities, and said that
Oncolytics is "currently engaged in" the systemic Trial at these
locations. This could be a confirmation that the enrollment has
already started at St George, and that the parallel (speeded up)
Trial is already in effect.

I am aware of other viral treatments causing a spiking of patient
temperatures into the 107 degrees F (42 degrees C) area, when
administered as multiple treatments. Brad specifically pointed out
that in our multiple treatments we did not see any temperature
spiking. Again, no significant adverse side effects for REOLYSIN.

Brad also made a strong case for co-therapy Trials, in that only co-
therapy (for biologics) will be considered as a first line
therapeutic (some of the existing chemo, no matter how bad, must
still be part of the treatment for "ethical" reasons). He showed a
graph with the current gold standard drug for pancreatic cancer
(Gemcitabine), and said that it was clear that it delayed the tumor
growth. A close look at the chart (slide 16) showed that there was a
slower tumor growth for much of the first 6 weeks, but that by week
7, tumors (both when treated with Gemcitabine, and when left
untreated), were tied at a doubling in tumor size (area). By week
11, the tumor grew to about 390% of its starting size when untreated,
and to about 400% of its starting size when treated continuously
through the 11 weeks with Gemcitabine. On the same chart, we saw the
tumor size as UNCHANGED after 11 weeks from where it started, when
using a treatment of only a single initial intra-tumoral injection of
a combination of Gemcitabine and REOLYSIN.

Considering that Brad was telling the whole Oncolytics story from
scratch, and within an allocated 20 minutes, I thought that he did a
very good job of it today.

rjc

[r.schaui]

#muycaro
im yahoo und stockhouse board wurde darauf hingewiesen, dass BT aussagen zu zulassungsverfahren in usa und europa gemacht und weiterhin gesagt hat, dass der aktienkurs von oncy nur halb so hoch wäre, wenn es lediglich testreihen in usa geben würde.
weiterhin wird spekuliert, dass aufgrund der aussagen und der bisher positiven ergebnisse reolysin schon als nicht zugelassenes medikament zum einsatz kommen könnte und die gesellschaft vorzeitig einnahmen generieren würde.

mfg
r.schaui

[muycaro]

Pressemitteilung von gestern nachmittag in den USA (Abend in Deutschland) - noch eine Präsentation:

Press Release Source: Oncolytics Biotech Inc.


Media Advisory - Oncolytics Biotech Inc. to Present at the 6th Annual Mass Opps Investment Conference
Monday November 1, 2:45 pm ET


CALGARY, Nov. 1 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY), will present a corporate overview of the Company at the 6th Annual Mass Opps Investment Conference on Thursday, November 4 at 10:50 A.M. (ET) to analysts, portfolio managers, investment bankers and other financial professionals. The event will be held at the Hilton Boston Logan Airport on November 4-5, 2004. A live audio webcast of the presentation will be available at: http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=W69… or on the company`s website at www.oncolyticsbiotech.com.
ADVERTISEMENT


It is recommended that listeners log on 15 minutes in advance of the presentation to register and download any necessary software. An audio replay will be available for two weeks following the presentation at http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=W69…

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

The webcast time is subject to change. This release and the presentation related thereto contain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control and which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or expectations implied by these forward-looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/prnews/041101/to068_1.html

[muycaro]

Pressemitteilung von eben gerade - einem neuen US-Patent wurde offiziell die Zulassung erteilt:


Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Inc. Announces Issuance of 13th U.S. Patent
Tuesday November 2, 8:36 am ET


CALGARY, Nov. 2 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) ("Oncolytics") has been granted U.S. Patent 6,811,775 entitled "Reovirus for the Treatment of Cellular Proliferative Disorders."
ADVERTISEMENT


"This patent further expands our portfolio of intellectual property specifically in the area of using recombinant reovirus for the treatment of neoplasia (cancers) and non-cancer cellular proliferative diseases such as neurofibromatosis," said Dr. Matt Coffey, Vice President, Product Development of Oncolytics. "This patent expands on previously issued patents in this area."

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

This news release contains forward looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements, including among others, the Company`s belief as to the safety and efficacy of the reovirus, the Company`s expectations as to the potential applications of the patented technology and other statements relating to anticipated developments in the Company`s business and technologies, involve known and unknown risks and uncertainties that could cause the Company`s actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward looking statements. The Company does not undertake to update these forward looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.


http://biz.yahoo.com/prnews/041102/to093_1.html

[r.schaui]

die anwendungsmöglichkeiten des reovirus sind nicht mehr allein auf krebszellen beschränkt,
auch nicht schlecht
mfg
r.schaui

[muycaro]

Aktuelle Pressemitteilung zu den Ergebnissen des 3. Quartals (höhere Ausgaben wie erwartet, gute Cashposition - bei derzeitiger Burnrate ausreichend für ziemlich genau 2 Jahre von jetzt an):

Link: http://biz.yahoo.com/prnews/041104/to169_1.html



Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Inc. Announces 2004 Third Quarter Results
Thursday November 4, 8:34 am ET


CALGARY, Nov. 4 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX: ONC, NASDAQ: ONCY) today announced its financial results for the three and nine-month periods ending September 30, 2004.
The current clinical program for REOLYSIN® includes a Phase I systemic administration trial in the United Kingdom, and a Phase I/II recurrent malignant glioblastoma trial in Canada. Enrolment is continuing as expected in the Phase I systemic administration trial at the Royal Marsden Hospital, and the Company added a second clinical site at St. George`s Hospital in London.

The Company also announced a poster presentation at the 16th EORTC-NCI-AACR 2004 Symposium entitled "The oncolytic reovirus, REOLYSIN®, augments the anticancer effects of cytotoxic agents in vitro against the ras-mutated human colon cancer cell line HCT 116." The data will be helpful in designing future clinical studies.

Oncolytics continues to prepare for the expected expansion of the human clinical program by working with manufacturing suppliers to ensure that supplies of REOLYSIN® are available.

"The Company continues to implement a step-wise approach to developing REOLYSIN® as a potential cancer therapeutic," said Dr. Brad Thompson, President and CEO of Oncolytics.

MANAGEMENT`S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS


This discussion and analysis should be read in conjunction with the unaudited financial statements of Oncolytics Biotech Inc. ("Oncolytics" or the "Company") as at and for the three and nine months ended September 30, 2004 and 2003, and should also be read in conjunction with the audited financial statements and Management`s Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") contained in Oncolytics` annual report for the year ended December 31, 2003. The financial statements have been prepared in accordance with Canadian generally accepted accounting principles ("GAAP").

FORWARD-LOOKING STATEMENTS

The following discussion contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company`s belief as to the potential of REOLYSIN® as a cancer therapeutic, the Company`s expectation regarding the adequacy of its existing capital resources, and the Company`s expectations as to the success of its research and development programs in 2004 and beyond, future financial position, business strategy and plans for future operations, and statements that are not historical facts, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, the Company`s ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals, uncertainties related to competition, changes in technology, the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Forward-looking statements are based on assumptions, projections, estimates and expectations of management at the time such forward looking statements are made, and such assumptions, projections, estimates and/or expectations could change or prove to be incorrect or inaccurate. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements except as required by law.

OVERVIEW

Oncolytics Biotech Inc. is a Development Stage Company


Since its inception in April of 1998, Oncolytics has been a development stage company and has focused its research and development efforts on the development of REOLYSIN®, its potential cancer therapeutic. The Company has not been profitable since its inception and expects to continue to incur substantial losses from its research and development. The Company does not expect to generate significant revenues until, if and when, its cancer product becomes commercially viable.

General Risk Factors

Prospects for biotechnology companies in the research and development stage should generally be regarded as speculative. It is not possible to predict, based upon studies in animals, or early studies in humans, whether a new therapeutic will ultimately prove to be safe and effective in humans, or whether necessary and sufficient data can be developed through the clinical trial process to support a successful product application and approval.

If a product is approved for sale, product manufacturing at a commercial scale and significant sales to end users at a commercially reasonable price may not be successful. There can be no assurance that the Company will generate adequate funds to continue development, or will ever achieve significant revenues or profitable operations. Many factors (e.g. competition, patent protection, appropriate regulatory approvals) can influence the revenue and product profitability potential.

In developing a product for approval, the Company will rely upon its employees, contractors, consultants and collaborators and other third party relationships, including the ability to obtain appropriate product liability insurance. There can be no assurance that these reliances and relationships will continue as required. In addition to developmental and operational considerations, market prices for securities of biotechnology companies generally are volatile, and may or may not move in a manner consistent with the progress being made by the Company.

Highlights

During the third quarter of 2004, the Company`s net loss and cash usage from operating activities was $3,096,042 and $1,820,118 respectively compared to $1,822,703 and $1,243,976 respectively for the third quarter of 2003. The increase in the Company`s net loss reflects the increase in its research and development activity in 2004 compared to 2003. Specifically, manufacturing and related process development expenses increased in the third quarter of 2004 compared to 2003 as the Company continues to increase its production of REOLYSIN® in order to supply its clinical trial program. Clinical trial expenses increased in the third quarter of 2004 compared to 2003 reflecting the ongoing patient enrollment in the Company`s systemic (intravenous) delivery clinical trial in the United Kingdom ("U.K.") and the addition of a second U.K. trial site. Also, the Company`s pre-clinical trial and research collaboration expenses increased in support of future clinical trial applications that include other jurisdictions and methods of application and future expansion of its intellectual property base. Finally, the Company entered into an agreement with one of the non-management founding shareholders that cancelled a portion of its future contingent payment obligations. As a result, the Company`s future contingent payment obligations have been reduced by 17.60%.

The difference between the Company`s net loss and cash usage from operating activities reflects non-cash charges associated with amortization, stock based compensation, foreign exchange loss, gains and losses from the sale of investments and the non-cash component of the royalty buy back.

The Company continues to receive cash proceeds from the exercise of warrants from previously closed financings. In the third quarter of 2004, $673,080 was received from the exercise of warrants and $3,813 was received from the exercise of stock options. During the nine months ended September 30, 2004, the Company received additional cash proceeds from a private placement of $6,223,763, from warrants of $3,973,119 and from stock options of $744,795 for a total from financing activities of $10,941,677. The Company exited the third quarter of 2004 with cash and short-term investments of $23,805,685 compared to $20,752,735 as at December 31, 2003.

THIRD QUARTER RESULTS OF OPERATIONS
(for the three months ended September 30, 2004 and 2003)


Net loss for the three month period ended September 30, 2004 was $3,096,042 compared to $1,822,703 for 2003. The increase in the Company`s net loss in the third quarter of 2004 was due to increases in the Company`s operating activities as follows:

Research and Development Expenses ("R&D")

2004 2003
$ $
-------------------------------------------------------------------------
Manufacturing and related process development
expenses 1,152,718 581,520
Clinical trial expenses 184,347 10,258
Pre-clinical trial expenses and research
collaborations 181,397 100,351
Cancellation of contingent payment obligation 400,000 -
Quebec scientific research and development
("SRED") refund - (222,000)
Other R&D expenses 313,919 253,424
-------------------------------------------------------------------------
Research and development expenses 2,232,381 723,553
-------------------------------------------------------------------------
-------------------------------------------------------------------------

For the third quarter of 2004, R&D increased to $2,232,381 compared to
$723,553 for the third quarter of 2003. The increase in R&D was due to
the following:

Manufacturing & Related Process Development


The Company`s manufacturing and related process development expenses increased to $1,152,718 compared to $581,520 for the third quarter of 2003. The increase in the third quarter of 2004 relates to the Company`s continued focus on the production of REOLYSIN® in order to supply its R&D activity. As well, additional process development costs were incurred relating to the technology transfer and set up costs associated with the Company`s second manufacturer.

Clinical Trial Programs

The Company`s clinical trial expenses increased to $184,347 in the third quarter of 2004 compared to $10,258 for the third quarter of 2003. The increase in the third quarter of 2004 relates to the Company`s patient enrolment in and supporting its systemic (intravenous) delivery clinical trial in the United Kingdom and costs associated with establishing a second clinical trial site for the systemic study.

Pre-Clinical Trial Expenses and Research Collaborations

During the third quarter of 2004, the Company`s pre-clinical trial expenses and research collaborations increased to $181,397 compared to $100,351 for the third quarter of 2003. Pre-clinical trial costs include toxicology and equivalency studies that are performed in support of future clinical trial applications. Research collaboration expenses include costs associated with collaborations that are intended to expand the Company`s intellectual property base and identify potential licensing opportunities arising from the Company`s technology base. These types of pre-clinical studies and research collaborations were limited in the third quarter of 2003.

Cancellation of Contingent Payment Obligation

On September 23, 2004, the Company reached an agreement that cancelled a portion of its future contingent obligation to one of its non-management founding shareholders for consideration of $400,000. The consideration paid included cash of $250,000 and non-cash consideration of 21,459 common shares valued at $150,000 and was recorded as additional research and development expense. The value of the common shares was based on the September 23, 2004 closing price of $6.99. As a result, the Company`s future contingent payment obligations have been reduced by 17.60% to 11.75% (14.25% prior to the cancellation payment) of payments received associated with a partnership or other arrangement for development. Similarly, if the Company develops the reovirus treatment to the point where it may be marketed at a commercial level, the payment referred to in the foregoing sentence has been amended to a royalty payment of 2.35% (2.85% prior to the cancellation payment) of Net Sales received by the Company for such products.

Quebec SRED Refund

The Company recorded a Quebec SRED refund in the third quarter of 2003 of $222,000 relating to research and development expenses incurred in 2001 in the Canadian province of Quebec. The Company filed its 2002 refund claim of $33,905 in the fourth quarter of 2003 and its 2003 refund claim of $23,940 in the second quarter of 2004.

Operating Expenses

2004 2003
$ $
-------------------------------------------------------------------------
Salary, insurance and other office expenses 364,717 349,025
Public company and other operating expenses 200,749 244,529
-------------------------------------------------------------------------
565,466 593,554
-------------------------------------------------------------------------
-------------------------------------------------------------------------


For the third quarter of 2004, the Company`s operating expenses decreased to $565,466 compared to $593,554 for the third quarter of 2003. The timing of professional fees contributed to the decrease in public company and other operating costs in the third quarter of 2004. The slight overall change reflects the fact that a majority of these costs are contractually fixed in nature and the Company has not had to increase its administrative costs to support the increase in its research and development activity.

Stock Based Compensation

2004 2003
$ $
-------------------------------------------------------------------------
Stock based compensation 48,878 437,554
-------------------------------------------------------------------------
-------------------------------------------------------------------------


Stock based compensation recorded in the third quarter of 2004 related to previously granted options that vested in this quarter and options granted to consultants. During the third quarter of 2003, the Company recorded stock based compensation of $437,554 associated with the granting of stock options to its employees, directors, and certain consultants.

Foreign Exchange Loss

2004 2003
$ $
-------------------------------------------------------------------------
Foreign exchange loss 239,881 861
-------------------------------------------------------------------------
-------------------------------------------------------------------------


The Company acquires investments in foreign currency to pay for anticipated expenses that are to be incurred in the United States ("U.S.") and the United Kingdom ("U.K."). These investments have provided better yields than their counterpart Canadian investments. As a result of recent movements in the U.S. and U.K. exchange rates the Company recorded a non-cash loss of $239,881 for the three month period ending September 30, 2004.

YEAR TO DATE RESULTS OF OPERATIONS
(for the nine months ended September 30, 2004 and 2003)


Net loss for the nine month period ended September 30, 2004 was $8,964,166 compared to $6,848,490 for 2003. The increase in the Company`s net loss was due to the following:

Research and Development Expenses ("R&D")

2004 2003
$ $
-------------------------------------------------------------------------
Manufacturing and related process development
expenses 3,339,895 1,112,598
Clinical trial expenses 436,542 56,703
Pre-clinical trial expenses and research
collaborations 735,461 238,316
Cancellation of contingent payment obligation 400,000 -
Quebec scientific research and development
("SRED") refund (23,940) (222,000)
Other R&D expenses 794,754 866,292
-------------------------------------------------------------------------
Research and development expenses 5,682,712 2,051,909
-------------------------------------------------------------------------
-------------------------------------------------------------------------

For the nine month period ending September 30, 2004, R&D increased to
$5,682,712 compared to $2,051,909 for 2003. The increase in R&D was due
to the following:

Manufacturing & Related Process Development


During the later half of 2003 and throughout 2004 the Company`s focus has been on the production of REOLYSIN® in order to supply its existing and planned R&D activity. As well, the Company has taken steps to mitigate the risk of economic dependence associated with having had only one supplier of REOLYSIN®. Consequently, for the nine month period ending September 30, 2004, almost 72% of the Company`s manufacturing and related process development expenses incurred related to the production of REOLYSIN® compared to only 51% for the same period in 2003. The Company`s manufacturing expenses in 2004 also include technology transfer and set up costs associated with the addition of a second supplier which is expected to be completed by the end of 2004.

The remaining manufacturing and related process development costs incurred in 2004 and 2003 relate to process development. During the first nine months of 2003 the Company was completing the development of its manufacturing process and also developing its viral and cell banks. Consequently, 49% of the Company`s manufacturing and related process development expenses incurred in 2003 related to these activities compared to only 28% in 2004.

For the remainder of 2004 and into 2005, the Company expects that it will continue to produce REOLYSIN® and that a majority of these costs will relate directly to manufacturing. As well, future manufacturing costs may be impacted by the need to supply additional clinical trials to be run by the Company as well as by the U.S. National Cancer Institute and to continue to supply future pre-clinical trial studies and research collaborations.

Clinical Trial Programs

The Company`s clinical trial expenses increased to $436,542 for the nine month period ending September 30, 2004 compared to $56,703 in 2003. The increase in clinical trial expenses relates mainly to the costs associated with the Company`s systemic (intravenous) delivery clinical trial in the United Kingdom which now includes a second trial site. The Company also continues to incur expenses related to the Canadian malignant glioma clinical trial.

For the remainder of 2004, the Company expects that clinical trial expenses will continue to be incurred as enrolment continues in the systemic (intravenous) delivery clinical trial for two clinical trial sites. As well, the Company expects that its clinical trial costs may increase as it continues to expand its clinical trial program into other jurisdictions.

Pre-Clinical Trial and Research Collaboration Expenses

The Company`s pre-clinical trial expenses and research collaboration expenses increased to $735,461 for the nine month period ending September 30, 2004 compared to $238,316 in 2003. Pre-clinical costs include toxicology studies and are incurred by the Company in support of expanding its clinical trial program into other jurisdictions and other applications. Research collaborations are intended to expand the Company`s intellectual property related to reovirus and other viruses and identify potential licensing opportunities arising from the Company`s technology base.

Operating Expenses

2004 2003
$ $
-------------------------------------------------------------------------
Salary, insurance and other office expenses 1,087,756 854,919
Public company and other operating expenses 1,025,127 966,147
-------------------------------------------------------------------------
2,112,883 1,821,066
-------------------------------------------------------------------------
-------------------------------------------------------------------------


For the nine month period ending September 30, 2004, the Company`s operating expenses increased to $2,112,883 compared to $1,821,066 for the nine month period ending September 30, 2003. Salary, insurance and other office expenses increased to $1,087,756 for the nine month period ending September 30, 2004 from $854,919 in 2003 due to the increase in staff levels and insurance premiums that commenced in the second quarter of 2003. Public company and other operating costs increased to $1,025,127 for the nine month period ending September 30, 2004 from $966,147 in the first nine months of 2003 reflecting the increased costs associated with the preparation of the Company`s annual filings, annual general meeting and shareholder mail outs plus additional expenses incurred in investor relations and business development.

Stock Based Compensation

2004 2003
$ $
-------------------------------------------------------------------------
Stock based compensation 788,974 506,343
-------------------------------------------------------------------------
-------------------------------------------------------------------------


Stock based compensation recorded during the nine month period ending September 30, 2004 increased to $788,974 compared to $506,343 for the nine month period ending September 30, 2003 associated with the granting of stock options to its employees, directors, and certain consultants.

Foreign Exchange Loss

2004 2003
$ $
-------------------------------------------------------------------------
Foreign exchange loss 353,964 9,662
-------------------------------------------------------------------------
-------------------------------------------------------------------------


The Company acquires investments in foreign currency to pay for anticipated expenses that are to be incurred in the United States ("U.S.") and the United Kingdom ("U.K."). These investments have provided better yields than their counterpart Canadian investments. As a result of recent movements in the U.S. and U.K. exchange rates the Company recorded a non-cash loss of $353,964 for the nine month period ending September 30, 2004.

Sale of Investments


2004 2003
$ $
-------------------------------------------------------------------------
Gain on sale of investment in BCY LifeSciences Inc.
("BCY") 34,185 -
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Loss on sale of investment in Transition
Therapeutics Inc. ("TTH") - 2,156,685
-------------------------------------------------------------------------
-------------------------------------------------------------------------


For the nine month period ending September 30, 2004 the Company sold 697,945 common shares of BCY for net cash proceeds of $133,609. This resulted in a net accounting gain of $34,185 after a write down of $12,817. As at September 30, 2004, the Company owned 200,000 common share of BCY with an estimated market value of $12,000. These remaining shares are held in escrow and will be released over the next two years.

For the nine month period ending September 30, 2003, the Company sold its investment in TTH for net cash proceeds of $2,552,695 resulting in a recorded loss of $2,156,685.

Commitments

As at September 30, 2004, the Company has committed to payments totaling $283,000 for activities primarily related to product manufacturing, product development and continued pre-clinical trial related work. The Company anticipates that these committed payments will occur in 2004. All of these committed payments are considered to be part of the Company`s normal course of business.

LIQUIDITY AND CAPITAL RESOURCES

Liquidity


As at September 30, 2004, the Company had cash of $23,805,685 (including cash, cash equivalents and short-term investments) and a working capital position of $22,884,144 compared to $20,752,735 and $20,088,868 respectively as at December 31, 2003. During the third quarter of 2004, the Company continued to receive cash proceeds from the exercise of warrants from previously closed financings of $673,080 for total cash proceeds for the nine month period from the exercise of warrants of $3,973,119. For the nine month period ending September 30, 2004, the Company has received a net amount of $10,941,677 which includes the proceeds from warrants, options and a private placement. This increase in the Company`s cash position has been offset by cash outflows from operating activities of $6,951,991 and purchases of intellectual property and other assets of $775,110.

The Company desires to maintain adequate cash and short-term investment reserves to support its planned activities which include its clinical trial program, production manufacturing, and its intellectual property expansion and protection as well as administrative activities. The Company believes that its existing capital resources are adequate to fund its current plans for research and development activities into 2007 without presuming the further exercise of outstanding warrants and options. In the event that the Company chooses to seek additional capital, the Company will look to fund additional capital requirements through the issue of additional equity as well as potential partnering or licensing opportunities. The Company recognizes the challenges and uncertainty inherent in the capital markets and the potential difficulties it might face in today`s environment. Market prices for securities in biotechnology companies are volatile and the ability to raise funds will be dependent on a number of factors, including the progress of R&D, availability of clinical trial information, and general market conditions.

Capital Expenditures

During the nine month period ending September 30, 2004, the Company spent $766,317 on intellectual property compared to $892,532 in 2003. The difference relates to variances in filing fees on existing patent applications.

SUMMARY OF QUARTERLY RESULTS

The following unaudited quarterly information is presented in thousands of dollars except for per share amounts:

-------------------------------------------------------------------------
2004 2003 2002
-------------------------------------------------------------------------
Sept. June March Dec. Sept. June March Dec.
(2) (2) (2) (2) (2)
-------------------------------------------------------------------------
Revenue(1) 194 183 117 127 102 41 43 44
-------------------------------------------------------------------------
Net
loss(3) 3,096 3,192 2,676 1,696 1,823 3,911 1,114 1,542
-------------------------------------------------------------------------
Loss per
common
share(3) $0.11 $0.11 $0.10 $0.06 $0.07 $0.17 $0.05 $0.07
-------------------------------------------------------------------------
Total
assets
(4),(6) 29,471 31,221 25,435 26,051 21,532 18,815 16,702 17,968
-------------------------------------------------------------------------
Total
cash
(5),(6) 23,806 25,522 20,298 20,753 15,843 13,486 6,887 8,319
-------------------------------------------------------------------------
Total
long-term
debt(7) 150 150 150 150 150 150 150 150
-------------------------------------------------------------------------
Cash
dividends
declared
(8) Nil Nil Nil Nil Nil Nil Nil Nil
-------------------------------------------------------------------------

(1) Revenue is comprised of interest income.
(2) Included in net loss and net loss per share in March 2004 and
December 2003 is a gain on sale of investment of $47,648 and $264,453
respectively and in September 2004, June 2004 and 2003 is a loss from
sale of investments of $12,817, $646 and $2,156,685 respectively.
(3) Included in net loss and net loss per share for 2002 is a future
income tax recovery of $647,618 (2004 and 2003 - nil).
(4) Subsequent to the acquisition of the Company by SYNSORB in
April 1999, the Company applied push down accounting. See note 2 to
the audited financial statements for 2003.
(5) Included in total cash are cash, cash equivalents and short-term
investments.
(6) The Company issued 2,332,730 common shares for cash proceeds of
$10,941,677 in 2004 (2003 - 5,062,978 common shares for $16,004,981
and 2002 - 1,040,000 common shares for $1,803,877).
(7) The long-term debt recorded in 2004, 2003 and 2002 represents
repayable loans from the Alberta Heritage Foundation.
(8) The Company has not declared or paid any dividends since
incorporation.


OTHER MD&A REQUIREMENTS


The Company has 29,639,335 common shares outstanding at November 2, 2004. If all of the Company`s warrants and options were exercised the Company would have 35,296,536 common shares outstanding.

Oncolytics Biotech Inc.

BALANCE SHEETS

As at,

September 30, December 31,
2004 2003
$ $
(unaudited) (audited)(x)
---------------------------

ASSETS
Current
Cash and cash equivalents 2,500,897 2,641,127
Short-term investments 21,304,788 18,111,608
Accounts receivable 48,585 64,224
Prepaid expenses 403,625 156,837
---------------------------
24,257,895 20,973,796

Capital assets 5,201,313 4,965,379

Investments (note 2) 12,000 111,425
---------------------------

29,471,208 26,050,600
---------------------------
---------------------------
LIABILITIES AND SHAREHOLDERS` EQUITY
Current
Accounts payable and accrued liabilities 1,373,751 884,928
---------------------------

Alberta Heritage Foundation loan 150,000 150,000
---------------------------

Shareholders` equity
Share capital (note 4)
Authorized: unlimited
Issued: 29,562,451 common shares
(December 31, 2003 - 27,208,262 common
shares) 55,241,253 44,712,589
Warrants (note 4) 2,195,418 1,598,250
Contributed surplus 4,469,544 3,699,425
Deficit (33,958,758) (24,994,592)
---------------------------
27,947,457 25,015,672
---------------------------

29,471,208 26,050,600
---------------------------
---------------------------
See accompanying notes
(x) Derived from the December 31, 2003 audited financial statements



Oncolytics Biotech Inc.

STATEMENTS OF LOSS AND DEFICIT

Cumulative
from
inception
Nine Month Nine Month Three Month Three Month on April 2,
Period Period Period Period Period
Ending Ending Ending Ending 1998 to
September September September September September
30, 2004 30, 2003 30, 2004 30, 2003 30, 2004
$ $ $ $ $
(unaudited) (unaudited) (unaudited) (unaudited) (unaudited)
-----------------------------------------------------------
Revenue
Rights revenue - - - - 310,000
Interest income 494,816 186,608 194,001 102,082 2,580,799
-----------------------------------------------------------
494,816 186,608 194,001 102,082 2,890,799
-----------------------------------------------------------

Expenses
Research and
development
(note 3) 5,682,712 2,051,909 2,232,381 723,553 22,101,242
Operating 2,112,883 1,821,066 565,466 593,554 9,315,008
Stock based
compensation 788,974 506,343 48,878 437,554 1,818,399
Foreign
exchange loss 353,964 9,662 239,881 861 355,866
Amortization 554,476 488,491 190,620 169,551 2,464,566
-----------------------------------------------------------
9,493,009 4,877,471 3,277,226 1,925,073 36,055,081
-----------------------------------------------------------

Loss before
the
following: 8,998,193 4,690,863 3,083,225 1,822,991 33,164,282
(Gain) loss on
sale and write
down of BCY
LifeSciences
Inc. (note 2) (34,185) - 12,817 - (298,638)

Loss on sale
of Transition
Therapeutics
Inc. - 2,156,685 - - 2,156,685
-----------------------------------------------------------

Loss before
taxes 8,964,008 6,847,548 3,096,042 1,822,991 35,022,329

Capital tax
(recovery) 158 942 - (288) 51,429

Future income
tax recovery - - - - (1,115,000)
-----------------------------------------------------------

Net loss for
the period 8,964,166 6,848,490 3,096,042 1,822,703 33,958,758

Deficit,
beginning of
period 24,994,592 16,450,561 30,862,716 21,476,348 -
-----------------------------------------------------------

Deficit, end
of period 33,958,758 23,229,051 33,958,758 23,299,051 33,958,758
-----------------------------------------------------------
-----------------------------------------------------------

Basic and
diluted loss
per share 0.31 0.29 0.11 0.07
-----------------------------------------------
-----------------------------------------------

Weighted
average
number
of shares 28,552,643 23,314,397 29,448,859 25,120,758
-----------------------------------------------
-----------------------------------------------

See accompanying notes



Oncolytics Biotech Inc.

STATEMENTS OF CASH FLOWS

Cumulative
from
inception
Nine Month Nine Month Three Month Three Month on April 2,
Period Period Period Period Period
Ending Ending Ending Ending 1998 to
September September September September September
30, 2004 30, 2003 30, 2004 30, 2003 30, 2004
$ $ $ $ $
(unaudited) (unaudited) (unaudited) (unaudited) (unaudited)
-----------------------------------------------------------

OPERATING
ACTIVITIES
Net loss for
the period (8,964,166) (6,848,490) (3,096,042) (1,822,703)(33,958,758)
Deduct
non-cash
items
Amortization 554,476 488,491 190,620 169,551 2,464,566
Non-cash
compensation 788,974 506,343 48,878 437,554 1,818,399
Foreign
exchange
loss 353,964 9,662 239,881 861 355,866
Cancellation
of contingent
payment
obligation
settled in
common shares
(note 3) 150,000 - 150,000 - 150,000
(Gain) loss
on sale and
write down of
BCY
LifeSciences
Inc. (34,185) - 12,817 - (298,638)
Loss on sale
of Transition
Therapeutics
Inc. - 2,156,685 - - 2,156,685
Future income
tax recovery - - - - (1,115,000)
Net changes
in non-cash
working
capital 198,946 (707,492) 633,728 (29,239) 776,244
-----------------------------------------------------------
(6,951,991) (4,394,801) (1,820,118) (1,243,976)(27,650,636)
-----------------------------------------------------------
INVESTING ACTIVITIES
Intellectual
property (766,317) (892,532) (340,389) (297,385) (3,431,143)
Other capital
assets (8,793) (46,430) (900) (4,999) (519,765)
Purchase of
short-term
investments (6,602,415)(12,029,492) (187,231)(12,029,492)(24,714,023)
Redemption of
short-term
investments 3,114,000 - 1,114,000 - 3,114,000
Investment in
BCY
LifeSciences
Inc. 133,609 - - - 456,637
Investment in
Transition
Therapeutics
Inc. - 2,552,695 - - 2,532,343
-----------------------------------------------------------
(4,129,916)(10,415,759) 585,480 (12,331,876)(22,561,951)
-----------------------------------------------------------
FINANCING ACTIVITIES
Alberta
Heritage
Foundation
loan - - - 150,000 -
Proceeds from
exercise of
warrants and
stock options 4,717,914 459,895 676,893 119,920 8,178,899
Proceeds from
private
placements 6,223,763 9,844,700 - 3,783,115 22,741,983
Proceeds from
public
offerings - - - - 21,642,602
-----------------------------------------------------------
10,941,677 10,304,595 676,893 3,903,035 52,713,484
-----------------------------------------------------------
(Decrease)
increase in
cash and cash
equivalents
during the
period (140,230) (4,505,965) (557,745) (9,672,817) 2,500,897
Cash and cash
equivalents,
beginning of
the period 2,641,127 8,319,244 3,058,642 13,486,096 -
-----------------------------------------------------------
Cash and cash
equivalents,
end of the
period 2,500,897 3,813,279 2,500,897 3,813,279 2,500,897
-----------------------------------------------------------
-----------------------------------------------------------

See accompanying notes



Oncolytics Biotech Inc.

NOTES TO FINANCIAL STATEMENTS

September 30, 2004 and 2003 (unaudited)

1. ACCOUNTING POLICIES

These unaudited interim financial statements do not include all of
the disclosures included in the Company`s annual financial
statements. Accordingly, these unaudited interim financial statements
should be read in conjunction with the Company`s most recent annual
financial statements. The information for the year ended December 31,
2003 has been derived from the Company`s audited financial statements
for the year then ended.

The accounting policies used in the preparation of these unaudited
interim financial statements conform with those used in the Company`s
most recent annual financial statements.

2. INVESTMENTS

During the three month period ending September 30, 2004, the Company
recorded a write down of its investment in BCY LifeSciences Inc.
("BCY") of $12,817 to reflect the investment`s market value of
$12,000. The write down was a result of a reduction in the BCY`s
market value (as estimated based on its publicly traded share price)
below the Company`s recorded book value that was deemed to be other
than temporary.

During the nine month period ending September 30, 2004, the Company
sold 697,945 of its BCY shares for net cash proceeds of $133,609
recording a gain on sale of investment of $47,002. As at September
30, 2004, the Company`s remaining ownership in BCY was 200,000 common
shares with a book value (net of write down) of $12,000.

3. CONTINGENCY

On September 23, 2004, the Company reached an agreement that reduced
its contingent payments to its founding shareholders through the
cancellation of a portion of these contingent payments from one of
its non-management founding shareholders. The consideration paid by
the Company consisted of $250,000 cash and 21,459 common shares
valued at $150,000 and has been recorded as research and development
expense. The value of the common shares was based on the closing
market price on September 23, 2004.

As a result of the above cancellation, if the Company receives
royalty payments or other payments as a result of entering into
partnerships or other arrangements for the development of the
reovirus technology, the Company is obligated to pay to the founding
shareholders 11.75% (14.25% prior to the cancellation payment) of the
royalty payments and other payments received. Alternatively, if the
Company develops the reovirus treatment to the point where it may be
marketed at a commercial level, the Company is obliged to pay the
founding shareholders 2.35% (2.85% prior to the cancellation payment)
of Net Sales received by the Company for such products.

4. SHARE CAPITAL

Authorized:

Unlimited number of common shares
Issued: Shares Warrants
---------------------------------------------------------------------
Amount Amount
Number $ Number $
---------------------------------------------------------------------
Balance,
December 31,
2002 22,145,284 30,191,572 550,000 114,286

Issued for cash
pursuant to
February 10,
2003 private
placement 140,000 265,540 77,000 16,000

Issued for cash
pursuant to
June 19, 2003
private
placement 2,120,000 5,912,113 1,272,000 543,287

Issued for cash
pursuant to
August 21,
2003 private
placement 1,363,900 3,801,778 813,533 349,176

Issued for cash
pursuant to
October 14,
2003 public
offering 1,200,000 5,528,972 720,000 617,428

Exercise of
options 64,700 149,615 - -

Exercise of
warrants 174,378 593,194 (174,378) (41,927)

Share issue
costs - (1,730,195) - -
---------------------------------------------------------------------

Balance,
December 31,
2003 27,208,262 44,712,589 3,258,155 1,598,250

Issued for cash
pursuant to
April 7, 2004
private
placement(i) 1,077,100 5,924,050 646,260 1,028,631

Issued pursuant
to cancellation
of contingent
payment (note 3) 21,459 150,000 - -

Exercise of
warrants 1,058,130 4,407,332 (1,058,130) (431,463)

Exercise of
options 197,500 778,951 - -

Share issue
costs - (731,669) - -
---------------------------------------------------------------------

Balance,
September 30,
2004 29,562,451 55,241,253 2,846,285 2,195,418
---------------------------------------------------------------------
---------------------------------------------------------------------

(i) Pursuant to a private placement, the Company sold 1,077,100 units
at an average price of $6.25 per unit for gross cash proceeds of
$6,731,875. The units were comprised of 1,077,100 common shares
and 538,550 common share purchase warrants and have ascribed
values of $5.50 and $1.50 respectively. Each common share
purchase warrant entitles the holder to acquire one common share
in the capital of the Company upon payment of $7.75 per share
until October 7, 2005. Share issue costs related to the private
placement were $728,918. In addition, the Company issued 107,710
common share purchase warrants to its advisor entitling the
holder to acquire one common share of the capital of the Company
upon payment of $7.00 per share until October 7, 2005. The
ascribed value of these additional warrants was $220,806 ($2.05
per additional warrant) and has been included in the share issue
costs above. The ascribed values of the warrants were based on
the Black Scholes Option Pricing Model.

The following table summarizes the Company`s outstanding warrants as
at September 30, 2004:
Weighted
Average
Outstanding, Issued Exercised Outstanding, Remaining
Exercise December During the During the September Contractual
Price 31, 2003 Period Period 30, 2004 Life (years)
-----------------------------------------------------------

$3.00 480,755 - 480,755 - 0.00

$4.00 1,243,867 - 396,522 847,345 0.22

$4.00 813,533 - 44,561 768,972 0.40

$5.00 120,000 - 66,042 53,958 0.54

$6.25 600,000 - 70,250 529,750 0.54

$7.00 - 107,710 - 107,710 1.00

$7.75 - 538,550 - 538,550 1.00
-----------------------------------------------------------

3,258,155 646,260 1,058,130 2,846,285 0.49
-----------------------------------------------------------
-----------------------------------------------------------

Stock Option Plan

The Company has issued stock options to acquire common stock through
its stock option plan of which the following are outstanding at:

September 30, 2004 December 31, 2003
-----------------------------------------------------
Weighted Weighted
Average Average
Stock Share Price Stock Share Price
Options $ Options $
-----------------------------------------------------
Outstanding at
beginning of
period 2,800,800 3.81 2,653,500 4.40
Granted during
period 284,500 7.66 599,000 3.71
Cancelled during
period - - (387,000) 7.97
Exercised during
period (197,500) 3.77 (64,700) 2.31
----------- -----------

Outstanding at
end of period 2,887,800 4.12 2,800,800 3.81
----------- -----------
----------- -----------

Options
exercisable
at end of
period 2,783,133 4.19 2,720,383 3.87
----------- -----------
----------- -----------

As the Company is following the fair value based method of accounting
for stock option awards, compensation expense related to options
granted to employees and consultants was $721,914 and $67,060,
respectively for the nine month period ending September 30, 2004
(September 30, 2003 - $383,060 and $123,283, respectively) and $4,638
and $64,178 respectively for the three month period ending
September 30, 2004 with an offsetting credit to contributed surplus.

5. COMPARATIVE FIGURES

Certain comparative figures have been reclassified to conform to the
current period`s presentation.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the
development of REOLYSIN(R), its proprietary formulation of the human
reovirus, as a potential cancer therapeutic. Oncolytics` researchers
have demonstrated that the reovirus is able to selectively kill
cancer cells and, in vitro, kill human cancer cells that are derived
from many types of cancer including breast, prostate, pancreatic and
brain tumours, and have also demonstrated successful cancer treatment
results in a number of animal models. Phase I clinical trial results
have indicated that REOLYSIN(R) was well tolerated and that the
reovirus demonstrated activity in tumours injected with REOLYSIN(R).




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

[muycaro]

Wer sich nochmal die heutige Präsentation (6th Annual Mass Opps Investment Conference) anhören will, klickt hier: http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=W69…

[muycaro]

Ach übrigens, wer die aktuelle Version des 21st Century reports haben möchte (.pdf Dokument zu öffnen mit dem Acrobat Reader), schreibe mir bitte eine Boardmail mit seiner Emailadresse.

[muycaro]

Unerwartet?! $10 Mio. Financing (kanadische Dollar), inkl Warrants ca. 16 Mio. Insgesamt werden ca. 1,5 Mio neue Aktien ausgegeben und ca. 750k Warrants, also eine Dilution von ca. 6,5%. Die Liquidität wächst damit auf ca. $34 Mio. an, bzw nach Ausübung der Warrants auf ca. $40 Mio. Ob es zum derzeitigen Zeitpunkt notwendig war, darüber lässt sich streiten. Ich denke das Management möchte sich langfristig mit ausreichend Cash absichern, zumal der Kurs der ausgegebenen Aktien historisch gesehen ja nicht der schlechteste (natürlich auch nicht der beste) ist. Ich persönlich hatte gehofft, dass das nächste Financing zu höheren Kursen (nach einigen Meldungen frühestens Anfang 2005 stattfinden würde, trotzdem ist es ok für mich (nicht "juchu" ok, aber ok). Das Financing wird am 25. November abgeschlossen. Hier die Meldung:


Oncolytics Biotech Inc. Enters into a Bought Deal Financing for $10 Million
11/5/04

/NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN
THE UNITED STATES. ANY FAILURE TO COMPLY WITH THIS RESTRICTION MAY
CONSTITUTE A VIOLATION OF U.S. SECURITIES LAW./

CALGARY, Nov 05, 2004 (Canada NewsWire via COMTEX) --
Oncolytics Biotech Inc. ("Oncolytics") (TSX: ONC, NASD
AQ: ONCY) announced today that is has entered into a bought deal agreement with Canaccord Capital Corporation. Under the agreement, Canaccord has agreed to purchase 1,504,000 units (the "Units") at a price of $6.65 per Unit, resulting in gross proceeds to Oncolytics of $10,001,600. Each Unit consists of one common share and one-half of one common share purchase warrant, with each whole common share purchase warrant entitling the holder to acquire one common share upon payment of $8.00 per share for a period of 36 months following the closing date. The net proceeds from the offering will be used to expand and accelerate Oncolytics` clinical trial programs and for general corporate purposes. The offering is expected to close on or about November 25, 2004.

The transaction is subject to the receipt of all necessary regulatory and stock exchange approvals.

The securities to be issued by Oncolytics have not and will not be registered under the United States Securities Act of 1933, as amended (the "1933 Act"), or the securities laws of any state of the United States, and may not be offered or sold in the United States absent registration or an applicable exemption therefrom under the 1933 Act and the securities laws of all applicable states. This press release is not an offer of securities in the United States.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN(R), its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN(R) was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN(R).

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company`s expectations related to the placement of the units, as to progress in the clinical trial program and the Company`s belief as to the potential of REOLYSIN(R) as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, ability of the Company to complete the private placement on the terms set forth in its agreements, the Company`s ability to obtain regulatory approval for the offering, the availability of funds and resources to pursue Research and Development projects, the efficacy of REOLYSIN(R) as a cancer treatment, the success and timely completion of clinical studies and trials, the Company`s ability to successfully commercialize REOLYSIN(R), uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements.

VIEW ADDITIONAL COMPANY-SPECIFIC INFORMATION: http://www.newswire.ca/en/releases/orgDisplay.cgi?okey=56839

For further information: For Canada: Oncolytics Biotech Inc.,Mr. Doug Ball, 210, 1167 Kensington Cr NW, Calgary, Alberta, T2N 1X7,Tel: [phone], Fax: [phone], www.oncolyticsbiotech.com; ForCanada: The Equicom Group, Joanna Longo, 20 Toronto Street, Toronto, Ontario,M5C 2B8, Tel: [phone] ext. 233, Fax: [phone],jlongo(at)equicomgroup.com; For United States: The Investor Relations Group,Gino De Jesus or Dian Griesel, Ph.D., 11 Stone St, 3rd Floor New York, NY,10004, Tel: [phone], Fax: [phone],mail(at)investorrelationsgroup.com
News release via Canada NewsWire, Toronto 416-863-9350 -MC-

Quelle:

http://www.stockhouse.ca/news/news.asp?newsid=2518149&tick=O…

[muycaro]

Achso, der Aktienkurs des Financing liegt bei umgerechnet ca. $5,51 US, also knapp 5% unter dem derzeitigen Kurs, wobei der Zeichner, in dem Falle Cannaccord noch die Warrants dazu bekommt.

[merx]

Schaut mal , die Mellon Bank hat ca.900 T aufgestockt !!!!



http://www.nasdaq.com/asp/holdings.asp?mode=&kind=&timeframe…


merx

[js200]

RAiDAR alerts Learn More About RAiDAR-LT


11/10/2004 (13:21 ET) ONCY: Volume Spike; 42% > 20-adsv, Stock -2.82% - Knobias



11/10/2004 (12:38 ET) ONCY: Filed 6-K Regarding 3rd Qtr Results (Nov-04 PR) - Knobias



11/10/2004 (12:35 ET) ONCY: Filed New Form 6-K, Foreign Material Event Report - Knobias



11/09/2004 (13:31 ET) ONCY: Volume Spike; 44% > 20-adsv, Stock -4.47% - Knobias



11/05/2004 (16:29 ET) ONCY: Filed New Form 6-K, Foreign Material Event Report - Knobias



11/05/2004 (14:07 ET) ONCY: Volume Spike; 45% > 20-adsv, Stock -4.08% - Knobias



11/05/2004 (11:36 ET) Oncolytics Biotech raising $10 million with bought-deal financing - Canadian Press, The (AP)



11/05/2004 (11:35 ET) Oncolytics Biotech raising $10 million with bought-deal financing - Canadian Press, The (AP)



11/05/2004 (07:28 ET) ONCY: Enters Bought Deal Financing for $10M - Knobias



11/05/2004 (07:25 ET) Oncolytics Biotech Inc. Enters into a Bought Deal Financing for $10 Million - Canada NewsWire



11/04/2004 (13:42 ET) ONCY: Filed New Form 6-K, Foreign Material Event Report - Knobias



11/04/2004 (09:35 ET) ONCY: Q3 Results 11c vs 7c; EPS +57% Y/Y; No Guidance - Knobias



11/04/2004 (09:02 ET) ONCY: To Present At MASS Biotechnology Conference @ 10:50 ET - Knobias



11/04/2004 (08:33 ET) Oncolytics Biotech Inc. Announces 2004 Third Quarter Results - Canada NewsWire



11/04/2004 (08:32 ET) Oncolytics Biotech Inc. Announces 2004 Third Quarter Results - PR Newswire



11/02/2004 (12:13 ET) ONCY: Filed New Form 6-K, Foreign Material Event Report - Knobias



11/02/2004 (12:10 ET) ONCY: Filed New Form 6-K, Foreign Material Event Report - Knobias



11/02/2004 (08:41 ET) ONCY: Announces Issuance of 13th US Patent - Knobias



11/02/2004 (08:37 ET) Oncolytics Biotech Inc. Announces Issuance of 13th U.S. Patent - Canada NewsWire



11/02/2004 (08:36 ET) Oncolytics Biotech Inc. Announces Issuance of 13th U.S. Patent - PR Newswire



11/02/2004 (08:35 ET) SECTOR: M Stanley Sees Near Term Risks in Pharma Group - Knobias



11/01/2004 (14:46 ET) Media Advisory - Oncolytics Biotech Inc. to Present at the 6th Annual Mass Opps Investment Conference - Canada NewsWire



11/01/2004 (14:45 ET) Media Advisory - Oncolytics Biotech Inc. to Present at the 6th Annual Mass Opps Investment Conference - PR Newswire



10/27/2004 (14:02 ET) ONCY: To Present At Rodman & Renshaw Conference @ 15:50 ET - Knobias



10/26/2004 (16:22 ET) ONCY: Short Interest UP 8.6% to 64.5K in Oct 2004 - Knobias

[js200]

#1 von js200 30.04.03 21:49:59 Beitrag Nr.: 9.319.869 9319869
Dieses Posting: versenden | melden | drucken | Antwort schreiben ONCOLYTICS BIOTECH INCORPORATED

3:46pm ET
1.65
0.62 (60.19%)
Day`s Range: 1.12 - 1.74
Day`s Volume: 627,300
Avg. Volume: 10,038

JS200

***********************************************
Last Trade: 5.307 Change: -0.192 (-3.492%)
Previous Close: 5.499 Volume: 125,500
Bid: 5.270 Ask: 5.350
Today`s Open: 5.650 # of Trades: 133

Von heute, ist doch schön zu sehen, wie die letzten 18 Monate gelaufen sind

JS200

[js200]

11/17/2004 (09:09 ET) SECTOR: M Stanley Sees Strong Growth in Respiratory Drug Mkt - Knobias
11/10/2004 (13:21 ET) ONCY: Volume Spike; 42% > 20-adsv, Stock -2.82% - Knobias
11/10/2004 (12:38 ET) ONCY: Filed 6-K Regarding 3rd Qtr Results (Nov-04 PR) - Knobias
11/10/2004 (12:35 ET) ONCY: Filed New Form 6-K, Foreign Material Event Report - Knobias
11/09/2004 (13:31 ET) ONCY: Volume Spike; 44% > 20-adsv, Stock -4.47% - Knobias

[muycaro]

So, das Financing ist abgeschlossen:


Oncolytics Biotech Inc. Closes $10 Million Bought Deal Financing

/NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN
THE UNITED STATES. ANY FAILURE TO COMPLY WITH THIS RESTRICTION MAY
CONSTITUTE A VIOLATION OF U.S. SECURITIES LAW./

CALGARY, Nov. 23 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX: ONC,
NASDAQ: ONCY) announced today that it has closed its previously announced
bought deal financing and issued 1,504,000 units, at $6.65 per unit, with each
unit consisting of one common share and one-half of one common share purchase
warrant, for aggregate gross proceeds of approximately $10 million. Each whole
common share purchase warrant entitles the holder to acquire, on or before
November 23, 2007, one common share of Oncolytics upon payment of $8.00 per
share.
Canaccord Capital Corporation acted as underwriter in connection with the
financing and received a commission of 7.5% of the gross proceeds and was
issued 112,800 warrants, each warrant entitling the holder to acquire, on or
before, May 23, 2006, one common share of Oncolytics upon payment of $7.06 per
share. Oncolytics will use the proceeds from this financing to expand and
accelerate its clinical trial programs and for general corporate purposes.
After giving effect to this transaction, Oncolytics has 31,153,871 common
shares issued and outstanding.
The securities issued by Oncolytics have not and will not be registered
under the United States Securities Act of 1933, as amended (the "1933 Act"),
or the securities laws of any state of the United States, and may not be
offered or sold in the United States absent registration or an applicable
exemption therefrom under the 1933 Act and the securities laws of all
applicable states.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the
development of REOLYSIN(R), its proprietary formulation of the human reovirus,
as a potential cancer therapeutic. Oncolytics` researchers have demonstrated
that the reovirus is able to selectively kill cancer cells and, in vitro, kill
human cancer cells that are derived from many types of cancer including
breast, prostate, pancreatic and brain tumours, and have also demonstrated
successful cancer treatment results in a number of animal models. Phase I
clinical trial results have indicated that REOLYSIN(R) was well tolerated and
that the reovirus demonstrated activity in tumours injected with REOLYSIN(R).

This press release contains forward-looking statements, within the
meaning of Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements, including the Company`s expectations related to
progress in the clinical trial programs and the Company`s belief as to the
potential of REOLYSIN(R) as a cancer therapeutic, involve known and unknown
risks and uncertainties, which could cause the Company`s actual results to
differ materially from those in the forward-looking statements. Such risks and
uncertainties include, among others, the availability of funds and resources
to pursue Research and Development projects, the efficacy of REOLYSIN(R) as a
cancer treatment, the success and timely completion of clinical studies and
trials, the Company`s ability to successfully commercialize REOLYSIN(R),
uncertainties related to the research and development of pharmaceuticals,
uncertainties related to the regulatory process and general changes to the
economic environment. Investors should consult the Company`s quarterly and
annual filings with the Canadian and U.S. securities commissions for
additional information on risks and uncertainties relating to the
forward-looking statements. Investors are cautioned against placing undue
reliance on forward-looking statements. The Company does not undertake to
update these forward-looking statements.



For further information: please contact: For Canada: Oncolytics Biotech
Inc.: Mr. Doug Ball, 210, 1167 Kensington Cr NW, Calgary, Alberta T2N 1X7,
Tel: [phone], Fax: [phone], www.oncolyticsbiotech.com; For
Canada: The Equicom Group, Joanna Longo, 20 Toronto Street, Toronto, Ontario
M5C 2B8, Tel: [phone] ext. 233, Fax: [phone],
[e-mail]; For United States: The Investor Relations Group,
Gino De Jesus or Dian Griesel, Ph.D., 11 Stone St, 3rd Floor, New York, NY
10004, Tel: [phone], Fax: [phone],
[e-mail]

[muycaro]

Sorry, habe den Link vergessen:

http://www.newswire.ca/en/releases/archive/November2004/23/c…

[js200]

11/24/2004 (16:22 ET) ONCY: Short Interest UP 19.3% to 76.9K in Nov 2004 - Knobias
11/23/2004 (16:00 ET) ONCY: Completes $10M Bought Deal PIPE w/Canaccord - Knobias
11/23/2004 (13:41 ET) ONCY: Filed 6-K Regarding $10M Bought Deal Financing (Nov-23 PR) - Knobias
11/23/2004 (13:10 ET) ONCY: Filed New Form 6-K, Foreign Material Event Report - Knobias
11/23/2004 (09:26 ET) ONCY: Closes $10M Bought Deal Financing - Knobias

[muycaro]

Ein interessantes Posting aus dem Yahoo Board - der Poster ist nicht wirklich bekannt, daher hier zunächst mal ohne Verifikation (hört sich authentisch an - trotzdem mit angemessener Vorsicht zu geniessen):


Conversation with BT on Friday
by: jeromeinthedome
Long-Term Sentiment: Strong Buy 11/27/04 10:34 pm
Msg: 34055 of 34124

1. BT believes the recent downward pressure is a result of the warrants theory and most of the December warrants have been excercised as of Thursday.
2. The recent bought deal was ONE institutional investor. The investor was not Mellon. He also received a call from Mellon after the deal was announced and was told that if any more financings were needed they would foot the bill. I got the distinct impression that Mellon was disappointed and that this was a slap on the wrist from his major shareholder. He also stated that his like of CC goes back two years when the company was close to running out of cash and CC offered 2MM at a time when there was little to justify that type of financing. BT has never forgotten that.
3. BT never directly commented on any upcoming trials/updates however reading between the lines he gave an indication that a US systemic has been applied for and they are awaiting an approval. Also, a radiation/Reo trial is planned in the UK due to the `super-additive effect` seen in preliminary studies. He has a goal of having 4/5 studies running in early 05 ....


Zusammenfassung + Spekulationen meinerseits:

1. Derzeitiger Druck auf den Aktienkurs wohl durch Ausübung der demnächst verfallenden Warrants (Aktien werden am freien Markt verkauft um Geld für die neuen Aktien freizumachen, was wiederum an Oncolytics direkt gezahlt wird).

2. Das letzte Financing wurde von einem einzelnen institutionellen Anleger gezeichnet - imho sehr positiv - Vertrauensbeweis. Mellon, die schon ca. 1,9 Mio Anteile halten meldeten sich wohl darauf bei Brad, um ihm mitzuteilen, dass sie das Financing ebenfalls übernommen hätten, und dass sie in Zukunft nicht übergangen werden wollen - Nachfrage nach Aktien also immer noch da. Da fragt man sich doch warum sie nicht gleich Mellon gefragt haben - Möglichkeiten: sie wollen sich bei den Institutionellen diversifizieren, oder es handelte sich um einen Partner nicht aus der Finanzwelt - das wäre natürlich interessant. Wir werden wohl den nächsten Bericht auf Nasdaq.com abwarten müssen um zu sehen, wohin diese Aktien gingen.

3. Brad hat nichts direkt zu geplanten Trials, etc. gesagt, allerdings meinte der Poster folgendes zwischen den Zeilen gelesen zu haben: die Versuchsreihen mit intravenöser Verabreichung wurden für die USA beantragt, sie warten jetzt auf Zulassung. Ausserdem sind weitere Versuchsreihen in England in Verbindung mit Bestrahlungstherapie geplant um bereits in vorherigen Studien beobachtete Synergieeffekte zu erforschen.
Ziel ist es Anfang 2005 4-5 klinische Tests am laufen zu haben.

Wie gesagt - insgesamt mit Vorsicht zu geniessen - da nicht verifiziert.


Ebenfalls sehr interessant:


nci/nih
by: dillbertt00
Long-Term Sentiment: Buy 11/29/04 01:50 am
Msg: 34123 of 34124

Last time I checked this link, I beleive Reolysin was given a IIA or IIB developement rank. Now it is listed as "Developement Stage III" which corresponds to "Clinical Trials, Phase I with progress to Phase II".

http://dtp.nci.nih.gov/docs/ddg/ddg_current.html


Wäre ja schön, wenn demnächst auch News von dieser Front kommen würden.

Viele Grüsse an alle, muycaro

[muycaro]

Aktuelle Shortposition in Toronto:

Symbol Report Date Volume Change
ONC 2004-11-15 457,616 -17,226
ONC 2004-10-31 474,842 16,953
ONC 2004-10-15 457,889 -33,178
ONC 2004-09-30 491,067 -168,612
ONC 2004-09-15 659,679 64,100
ONC 2004-08-31 595,579 201,400
ONC 2004-08-15 394,179 -10,400
ONC 2004-07-31 404,579 -113,258
ONC 2004-07-15 517,837 -83,500
ONC 2004-06-30 601,337 2,800
ONC 2004-06-15 598,537 -10,600

Nasdaq: Shares Short (as of 8-Nov-04): 77.00K

Mitte dieses Monats waren also ca. 535k Aktien leerverkauft.
Die neuen Zahlen sollten Anfang nächsten Monats kommen.

[muycaro]

Interessant (Oncolytics hält auch Patente im Bereich Behandlung von Tumoren via HSV):

December 01, 2004

Newswise — In laboratory studies at Cincinnati Children`s Hospital Medical Center, researchers have successfully treated the most common malignant abdominal tumor of childhood: neuroblastoma tumors. Researchers successfully treated the tumor in mouse models by administering a treatment based on a weakened version of the herpes simplex virus.

"The field of oncolytic viruses is a growing area in identifying new therapies for treating cancer. In using viral-based therapies, the disease-causing agent in the virus was deactivated before the virus was injected into the tumor. The virus then kills the tumor cells, in part, by activating the mechanism that triggers the destruction of cells from within, or cell suicide.

"We have begun to unravel the mechanisms of how the cells are killed, so now, we can hopefully improve upon this mechanism in subsequent studies," Dr. Cripe said.

Dr. Cripe and colleagues initially considered gene therapies to treat neuroblastoma tumors, but gene therapy is limiting in that the gene must be delivered to every single tumor cell individually. In comparison, oncolytic viruses can replicate and spread and theoretically can efficiently reach more tumor cells.

Dr. Cripe indicated that viral-based therapies could hold implications for other childhood and adult cancers. "We have data that suggest certain sarcomas in children are sensitive to this therapy. In addition, other research has shown in animal models that certain adult cancers are responsive as well. Furthermore, some clinical trials for adult cancers have been launched," [said Timothy Cripe, MD, PhD, director of the Comprehensive Musculoskeletal Tumor Clinic and Translational Research Trials Office at Cincinnati Children`s and senior author of the new study.]

Existing treatments for neuroblastoma tumors include the surgical removal of the tumor, chemotherapy and radiation. In cases where the cancer has metastasized, blood and marrow transplants are conducted.

--from Cincinnati Children`s Hospital Medical Center news release

[gag2000]

hallo,

hat jemand eine neue einschätzung zu oncy ?

lohnt es aktuell weiter nachzukaufen ?

[dickson]

[muycaro]

"hallo,

hat jemand eine neue einschätzung zu oncy ?

lohnt es aktuell weiter nachzukaufen ?"


Ist natürlich schwierig Dir dazu etwas zu sagen. Meine Meinung ist sehr subjektiv, da ich zigtausende ONCY Aktien halte, von daher... Ausserdem kenne ich nicht Deine Risikobereitschaft-/streuung, wieviele Aktien Du schon hast, etc.

ONCY ist ein sehr spekulativer Wert.

Alle Welt wartet auf die Resultate der klinischen Versuchsreihe in England.
Wann diese bekanntgegeben werden?
Keine Ahnung.
Der Trial hatte planmässig einen Endpunkt im Februar 2005. Ob dies eingehalten werden kann weiss ich nicht, da es wohl am Anfang etwas langsam ging Patienten zu rekrutieren, daher wurde ja auch noch das St. George`s Hospital in die Versuchsreihe miteinbezogen (+ Royal Marsden).

Weiterhin kann man sagen, dass es cashmässig nach den letzten Platzierungen von Aktien recht gut aussieht.
Cash sollte bei ca. kanadischen $40 Mio liegen, die Burnrate sollte für die nächsten Jahre nicht mehr als 1 Mio/Monat betragen (laut Management), hier also erstmal keine grösseren Sorgen.

Das grösste Problem der Aktie derzeit ist das Newsvakuum was in den letzten Monaten entstanden ist.
Grundsätzlich ist dies evtl. sogar positiv, da sie negative Ergebnisse bei den Versuchsreihen eher melden müssten (bei Nebenwirkungen hätten wir mit Sicherheit schon etwas gehört).

Abschliessend bleibt zu sagen, dass die ganze Story die hier hintersteckt sehr spekulativ ist.
Das Chance-Risikopotential ist enorm (der Markt für Medikamente im Krebsbereich liegt bei 60 Milliarden Dollar/Jahr allein in den USA, Tendenz steigend).
Sollten die klinischen Versuchsreihen weiterhin Erfolge zeigen (schaut Euch nochmal das Bild auf der Webseite von der Head and Neckcancer Patientin an - erstaunlich!), eine Partnerschaft mit einem grösseren Pharmakonzert geschlossen werden, etc. so wird sich der Wert über die nächsten Jahre aussergewöhnlich entwickeln können, allerdings gibt es auch immer noch das Risiko dass alles nicht so klappt wie gewünscht...

Viele Grüsse und viel Glück an alle, muycaro

[muycaro]

Ein paar interessante neue Posts, die eine unerwartet lange Lebensdauer von Patienten (im Endstadium, nach vergeblicher Behandlung mit den derzeit konventionellen Mitteln) zu belegen scheinen (siehe auch das verlinkte PDF Dokument).

Sollte das so stimmen, waren einige Patienten nach mehreren Jahren(!) nach der einfachen intratumoralen Injektion mit Reolysin noch am Leben (die Lebensdauer der Patienten war zuvor durch unabhängige Fachmediziner mit maximal 3-6 Monaten prognostiziert wurden).

Hinzu kommt, dass die Patienten randomisiert ausgewählt wurden, d.h. keinerlei Screening/Test auf eine RAS Aktivierung des Krebses durchgeführt wurde (nur 66% sind im Durchschnitt Ras aktiv - durch ein vorheriges Ras Screening könnten also nicht aktivierte ausgeschlossen werden).

Weiterhin hatten einige der Patienten metastasierenden Krebs, was wiederum für einen sogenannten "Field Effect" spricht, da auch Metastasen weiter entfernt von der Injektionsstelle schrumpften. Diese Ergebnisse wurden ausschliesslich nach EINMALIGER Injektion von Reolysin erzielt.

Im aktuellen Marsden Trial gibt es A. Eine intravenöse Verabreichung durch den sich das Reolysin noch besser verbreiten kann und B. weitere Nachbehandlungen, die den Erfolg noch wesentlich verbessern sollten.

Keine schwereren Nebenwirkungen wurden beobachtet, aber lest selbst (wenn das alles so stimmt bedeutet das m.E. eine äussert "goldene" Zukunft für Patienten, Reolysin und Oncolytics - besonders im Vergleich mit den lebensverlängernden Effekten anderer zugelassener Medikamente in diesem Bereich):



New Pub: QL - A Phase 1 w/ Reolysin
by: moonthruclouds
Long-Term Sentiment: Strong Buy 01/29/05 08:38 am
Msg: 37931 of 37997

Publication Title:
Individualized quality of life, standardized quality of life, and distress in patients undergoing a phase I trial of the novel therapeutic Reolysin (reovirus).

By: Carlson LE, Bultz BD, Morris DG.

Published in: Health Qual Life Outcomes. 2005 Jan 27;3(1):7

Link to abstract (click on No.1 to view):

http://vivisimo.com/search?input-form=simple-clustermed-vivi…


moon


Re: New Pub: QL - A Phase 1 w/ Reolysin
by: geoffb101 01/29/05 08:56 am
Msg: 37932 of 37997

From the abstract:

"Global QL on the EORTC QLQ C-30 and depression scores were associated with time to death in the nine patients who had died at the time of writing."

Wonder when this was written?

Geoff


Re: New Pub: QL - A Phase 1 w/ Reolysin
by: matdu1 01/29/05 09:20 am
Msg: 37933 of 37997

"Wonder when this was written?"

The article was submitted on Oct 26, 2004. Normally it takes a few months to prepare a manuscript, so I assume it was written in summer of 2004.

You can see the PDF version of the article at:

hxxp://www.hqlo.com/content/pdf/1477-7525-3-7.pdf

Concerning the survival, at the time of writing, 9 of the 16 patients had died. The median time of survival was 136 days after the interview, with a range of 21-664 days.

Seven patients were still alive with median time 242 days after the interview,with a range of 207-709 days after the interview.

I believe the phase I trial was done in 2001 (?) and it appears that 7 of the patients were still alive almost 3 yrs after Reolysin treatment.



Re: New Pub: QL - A Phase 1 w/ Reolysin
by: castandretrieve 01/29/05 09:26 am
Msg: 37934 of 37997

And all without any pre-screaning for RAS, correct?


Re: New Pub: QL - A Phase 1 w/ Reolysin
by: taos_ranch 01/29/05 09:30 am
Msg: 37935 of 37997

Also, note the types cancer treated, breast cancer and melanoma:

"The remaining 16 patients who provided data all had metastatic disease that was considered incurable, 6 men and 10 women. The largest patient group consisted of five women who had metastatic breast cancer, followed by three patients with malignant melanoma."


Re: New Pub: QL - A Phase 1 w/ Reolysin
by: matdu1 01/29/05 09:41 am
Msg: 37936 of 37997

"And all without any pre-screaning for RAS, correct?"

No they were not screened for Ras activation.

-I would like to correct my previous statement: it appears that 7 of the patients were still alive almost 3 yrs after Reolysin treatment. It looks like they did the analysis earlier than the summer of 2004. See below:

Procedures
After patients had been referred to the above mentioned trial, but prior to being definitively accepted
(pending complete assessment of inclusion/exclusion criteria), patients met with a psychologist (LC) for
the assessment protocol. At that time they were interviewed concerning their expectations about their
health, both without any further conventional treatment and with the potential experimental treatment.
They then completed the interview-based individualized QL interview, followed by the quantitative
questionnaires as detailed below. All 16 patients followed the same procedures.

Results
Subjects
Demographic characteristics and disease variables of participants are presented in Table 1. Patient #10
was registered in the trial but too ill to complete any of the questionnaires or the interview. Therefore no
data for this patient is included in the study. The remaining 16 patients who provided data all had
metastatic disease that was considered incurable, 6 men and 10 women. The largest patient group
consisted of five women who had metastatic breast cancer, followed by three patients with malignant
melanoma. Patients ranged in age from 32 to almost 76 years old, with a median age of 53 years. They
had been diagnosed with cancer for a median of 3.3 years (range 0.5-26.9 years) before entrance to the
study. They had on average 16 years of education (range 12-25), and therefore represented a highly
educated group. At the time of analysis, nine of the patients had died, at a median of 136 days from the
time of the interview (range 21-664 days). The remaining seven were still alive, a median of 242 days from
the time of the interview (range 207-709 days).


Re: New Pub: QL - A Phase 1 w/ Reolysin
by: taos_ranch 01/29/05 09:42 am
Msg: 37937 of 37997

A quick addition to my own comment, table 1 on page 14 of the pdf file gives a detailed listing of the patents, including their type of cancer and status (alive/dead).

Those still alive included (copied from chart):

2 Male 50 Squamous carcinoma (head and neck) 0.7 Lymph nodes Alive-709 days

6 Female 60 Metastatic Breast carcinoma 2.7 Chest wall /lungs /retroperitoneum Alive-529 days

11 Male 42 Malignant melanoma 6.4 Liver/lung/spleen Alive-368 days

14 Female 55 Malignant melanoma 1.8 Axilla /lung /liver Alive-242 days

15 Female 48 Metastatic breast carcinoma 2.8 Neck /Chest Wall /Brain Alive-242 days

16 Female 46 Soft tissue sarcoma 3.9 Lung/skin/breast/ retroperitoneal Alive-227 days

17 Male 70 Squamous carcinoma (head and neck) 9.7 Head/neck Alive-207 days


Re: New Pub: QL - A Phase 1 w/ Reolysin
by: xyz1308 (58/M/New Jersey USA) 01/29/05 10:30 am
Msg: 37941 of 37997

Whoever found that publication - great find. Seven `long term` survivors out of 16 in a phase I trial given that:

Only 2/3`s on average should have been Ras Activated --> theoretical Ras population reduced to 10 and seven survivors!

There was dose escalation - so some of the patients got very minute amounts of the virus injeceted into their tumors i.e. the immune system might have cleared the virus from the system before it had chance to spread in some cases because of the low dosage.

There was no re-treatment (as far as I know) in the protocol. Anybody know differently?

I think this is stunning news - no wonder why Marsden wanted to run a Systemic trial.

Imagine the results they could be getting at Marsden if they are re-treating. Also imagine he results they would get if they test for Ras activation before treatment (which they are not doing at Marsden as far as is known).

I don`t blame the company one bit for keeping its silence on the developments. It looks to me that they could have a stunning cancer treatment and want to lock up all the IP protection they can before any word of success gets out. I also believe they are still discovering just how the virus works and want to cover all the bases in their IP on how it (and other viruses cause cancer cell death).

I am much more secure in my Oncolytics investment this morning. Thanks to those who posted the article and commented on it.

All my personal opinion.

XYZ




Und so weiter siehe Post #37931 und darauf folgenden im Yahoo Board. Gibt noch einige weitere interessante Kommentare, könnt Ihr dort selbst nachlesen, wird sonst zu lang. Alles in allem - "wow" - what more can I say. Viele Grüsse an alle!

[muycaro]

Noch ein kurzer Zusatz: dies bezieht sich alles auf den ersten klinischen Phase I Versuch, in dem einige Patienten nur ein zehntel der Dosis die an Mäusen getestet wurde bekamen...
Wenn es also bei suboptimaler, einfacher (keine Nachbehandlung wie im Royal Marsden) Dosierung, nur direkter Injektion in den Tumor (vs. intravenös im Royal Marsden) ohne Pre-Screening/Test auf Ras Aktivierung und ohne gleichzeitige Chemo- oder Strahlentherapie schon derart wirkungsvoll ist...
Sieht vielversprechend aus (eventuell etwas untertrieben).

[muycaro]

Re: 16 pts with incurable metastatic ca
by: clinical_trials_planned 01/29/05 11:27 am
Msg: 37951 of 37997

17 patients enrolled with incurable metastatic cnacer.

Quote from the paper:

"Results
Subjects
Demographic characteristics and disease variables of participants are presented in Table 1. Patient #10
was registered in the trial but too ill to complete any of the questionnaires or the interview. Therefore no
data for this patient is included in the study. The remaining 16 patients who provided data all had
metastatic disease that was considered incurable, 6 men and 10 women."

Take away summary:

* 17 patients enrolled in the trial - 16 patients completed the trial. The 16 who were enrolled in the trial were given approximatley 3 months to live.

* 7 patients still living 3 years after being administered reovirus.

* 43.75% of study participants still alive after 3 years.

* ONCY`s Reolysin is effective in the treatment of cancer, even after only a single dose administration.

[r.schaui]

#muycaro
die veröffentlichung dieser sicherlich überraschend guten ergebnisse wird nicht nur positiv gesehen, siehe stockhouse

die tests sollen bereits 2000/2001 durchgeführt worden sein

aufgrund der von oncy mitgeteilten "überlebenszeiten" müssen nach berechnungen im stockhouse board die ergebnisse bereits ende 2003 vorgelegen haben

warum werden die ergebnisse erst nach 15 monaten veröffentlicht und warum zu diesem zeitpunkt ??

mfg
r.schaui

[muycaro]

Natürlich wurde der Phase I Test in 2001 durchgeführt, siehe auch die zugrunde liegende Testreihe auf Oncolytics Webseite:

http://www.oncolyticsbiotech.com/clinical.html#Phase1

Man kann das angesprochene PDF Dokument auch nochmal hier direkt herunterladen (Adobe/Acrobat Reader wird benötigt):

http://www.hqlo.com/content/pdf/1477-7525-3-7.pdf" target="_blank" rel="nofollow ugc noopener">http://www.hqlo.com/content/pdf/1477-7525-3-7.pdf


Das Dokument ist ja nicht direkt von Oncolytics sondern von Wissenschaftlern/Medizinern (unter anderem Dr. Morris), die im Nachhinein nochmal die Daten ausgewertet haben (natürlich über die Versuchsreihen zeitlich hinausgehend, ansonsten könnten ja auch nicht derart hohe Überlebenszeiten beschrieben werden). Das Dokument wurde im Oktober 2004 erstellt und das komplette Abstract erst am 27. Januar veröffentlicht.

Warum das Dokument jetzt erst veröffentlicht wurde kann ich Dir auch nicht sagen, wahrscheinlich wurde es seit Oktober 04 noch von anderen in dem Bereich tätigen Stellen gelesen und besprochen um dann endgültig veröffentlicht zu werden.

Ich habe das ganze gestern auch zum ersten mal gesehen und noch nicht richtig Zeit gehabt mich damit zu beschäftigen. Bin eigentlich eher durch Zufall wegen des ganzen "Buzz" im Yahoo Board am Sonntag Abend darauf gestossen.

Ich habe mir die Stockhouse Beiträge auch aus Zeitmangel noch nicht alle durchgelesen, aber es sind mal wieder die "üblichen Verdächtigen" die dort rummeckern (aka. bilo...). Man kann natürlich immer alles so oder so sehen - allerdings gibt es eben nicht nur schwarz oder weiss.

Ich denke mal wir werden wohl noch etwas abwarten müssen, bis sich die Sache endgültig aufklärt (ich werde mal eine email an die IR von Oncolytics schreiben und fragen, warum es dazu keine PR gab).

Hier noch ein neuer Artikel aus einer anderen Publikation:

http://www.macleans.ca/topstories/health/article.jsp?content…

P.S.: An alle: Bitte in Zukunft Links mit den UBB Befehlen versehen, ansonsten muss man bei diesem w:o Thread immer seitlich scrollen, was etwas umständlich ist.

[muycaro]

Meine Email an Cathy Ward (ONCY IR):

Hey Cathy,

would you care to let me know why these findings (which are much more
detailed than the "final results" which Oncolytics issued in their news release way
back) were not publically released via a PR?

http://www.hqlo.com/content/pdf/1477-7525-3-7.pdf


I mean look at the share price erosion and the last time you issued any
significant news let alone on financings... Maybe you should think about keeping
your shareholders more up to date of what is happening (and don`t tell me you
put it up on your website, cause I know that). I accidently came across this
paper when I read some forums about Oncolytics.

If you issued something official maybe even (potential) investors not in the
medical field or readers of online discussion forums would see these
findings.

Any update on the progress would be appreciated.

Will you announce when the Marsden trial progresses into phase II of the
trial?

Best Regards,

xxx

------------------------------------------------------------------------------
------------------------------------------

Brad Thomson hat mir darauf geantwortet. Wohl weil ich schon einige Diskussionen/Anregungen mit ihm in der Vergangenheit wegen ONCYs PR Politik hatte.

Brad Thomsons (ONCYs CEO) Antwort:

xxx:

Cathy forwarded your email to me.

And again thanks for your input. We had decided a while ago to be more
proactive, based largely on comments by people like yourself, about spreading
information about the company. We also had to decide where we will do this and
where we won`t do this. The line we drew was if it was our work, or work
that we sponsered through our collaborators, and was significant, then we would
press release it. If it was work of interest, but not work we sponsered or
had sponsered and was of less significance, then we would draw attention to it
on our web site. The thinking was that would increase disclosure. Some
things are interesting that don`t warrant a press release.

In this case, the data reported in the paper was not sponsered by
Oncolytics. The data was collected outside of our clinical study. The data wasn`t
part of our objectives for the study which were to evaluate toxicology, and to
look at tumour responses. Which we have reported on in detail.

I do not have an answer to your Marsden question, but will consider it.

Brad Thompson


________________________________

[muycaro]

Hier ein neuer Artikel der im Magazin Technology Review des Massachusetts Institute of Technology erschienen ist (das MIT ist eine Eliteuni in den USA). Gleich am Anfang wird Oncolytics erwähnt. Das Magazin wird an sämtliche dort eingeschriebene Studenten, Mitarbeiter und weitere Abonnenten verschickt. Die Auflage beträgt ungefähr 300K Stück. Der Artikel steht ebenfalls auf deren Webseite mit mehr als 1M Seitenaufrufen im Monat.


Declaring Biowar on Cancer
By Erika Jonietz March 2005


The anthrax letter attacks of 2001 drew a lot of attention to the question of biological warfare, sparking fears that terrorist-funded biologists could create “superbugs,” bacteria or viruses designed to kill. But efforts to build designer bugs are not always malicious. In one unusual form of biological attack, researchers are engineering viruses to seek and destroy the cells that run amok in cancer patients. After more than 10 years of lab work, researchers in the field of “oncolytic therapy” have reached a sort of critical mass, deploying their designer viruses in a number of human trials.


The idea is astonishingly simple: let viruses do what they always do—but only to cancer cells. All viruses infect host cells and trick them into replicating the virus until the cells burst, releasing the new viruses. But unlike other viruses, oncolytic, or cancer-bursting, viruses reproduce in and destroy only cancer cells, leaving normal cells pretty much alone. “Viruses are a parasite, and they want to grow in cells that replicate very effectively to have the highest opportunity for themselves to replicate,” says Matt Coffey, chief scientific officer of Oncolytics Biotech in Calgary, Alberta. “Cancer cells fit that bill.”

Researchers usually begin by choosing a virus that replicates and kills cells aggressively, such as herpes simplex virus, tinkering with the genes it needs to reproduce so the organism grows exclusively in cancer cells, sometimes even targeting specific types of tumors. In some cases, genes are also added to the virus to give it an extra punch: the virus might produce a protein that, for instance, converts a nontoxic drug into a potent chemotherapeutic agent only in cancer cells or revs up the patient’s immune system to attack the tumor.

Several oncolytic viruses have entered human tests. Robert Martuza, a neurosurgeon at Massachusetts General Hospital and Harvard Medical School and a pioneer of oncolytic therapy, has done human safety tests of mutated herpes strains against brain cancer, for instance. Kenneth Tanabe, chief of surgical oncology at Massachusetts General, is participating in a liver-cancer clinical trial of a herpes strain owned by German biotech company Medigene. The company will also soon begin human tests of a strain targeted against brain cancer. Oncolytics Biotech is currently conducting clinical tests on how reovirus performs against an aggressive brain cancer called glioblastoma multiforme, as well as several different solid tumors. Cell Genesys, based in South San Francisco, CA, is developing cancer-targeted versions of adenovirus, often the culprit behind the common cold; one is already being tested in prostate cancer patients, and another should enter clinical trials against bladder cancer early this year.

One expectation of all these groups is that oncolytic therapies will not only treat previously incurable cancers but also help eliminate some of the worse aspects of cancer care. Although test patients sometimes suffer the low fevers or mild malaise typical of viral infection, none have shown the severe side effects associated with chemotherapy and radiation. Viral therapy should also enable doctors to destroy tumors without harming nearby tissue, a common problem with radiation and surgical treatments. Early results from the human tests have been promising; some patients experienced significant tumor shrinkage.

Still, oncolytic therapies face a major hurdle. As David Bartlett, chief of surgical oncology at the University of Pittsburgh Medical Center Cancer Centers, explains, “The single biggest drawback on all of these viruses is the host immune system reaction,” which attacks oncolytic viruses as it would any other virus. Many people have existing immunity to common viruses, such as herpes and adenovirus; were such people to undergo oncolytic therapy, their immune systems could destroy the viruses before they ever infected the cancer cells. The reaction could also preclude multiple rounds of treatment, since patients could develop immunity to the engineered virus after the first exposure.

Researchers are exploring ways of coping with patients’ immune reactions to oncolytic viruses. One possibility is to administer the virus directly to the tumor, largely bypassing the blood-based immune system. Or the immune system might turn out to be as much friend as foe. “The immune system will attack the virus,” says Martuza. “But at the same time, it will attack the cells the virus is growing in, so you’ll get a rejection not only of the virus but also of the cancer cells.”

It will almost certainly be several years before the first oncolytic viruses receive federal approval and become first-line therapies for cancer, but with more than a decade of experience behind them, researchers are optimistic that they will eventually succeed. “I don’t honestly know which of these viruses is going to work, and it may turn out that one will work for one type of cancer, one for another type of cancer,” says Martuza. “It almost doesn’t matter. It’s a blossoming field, and some of them will end up working.”


http://www.technologyreview.com/articles/05/03/issue/forward…

[muycaro]

Ein weiterer Artikel zum Thema Virus als "Krebsbekämpfer", diesmal mit einem modifizierten Masernvirus (soll aber laut Artikel noch ca. 10 Jahre dauern bis die ersten klinischen Versuche stattfinden können).

Die Mayo Klinik ist eine weltweit anerkannte Kapazität im Krebsforschungsbereich.

Zur Zeit schiessen die Meldungen über virologische Onkologie nur so aus dem Boden.
Meines Erachtens ein gutes Zeichen, da sich hierduch die Validität des Konzeptes Virus vs. Krebs abzeichnet.

Mayo makes cancer-killing virus

Thu, Feb 3, 2005


By Jeff Hansel

The Post-Bulletin

A research team led by Mayo Clinic has made an "obedient virus" that
converts the measles virus into a therapeutic killer that hunts down and
destroys cancer cells.

"The virus that we are engineering here is actually the vaccine strain that
we all give to our children, that has a phenomenal safety record," said Dr.
Stephen Russell, director of Mayo`s Molecular Medicine Program.

An advance article about the research is available electronically in Nature
Biotechnology. According to Mayo, specialists noticed several years ago
that the virus strain used to make vaccine showed anti-cancer effects. But
Russell and his colleagues worried the measles virus might infect
non-cancer cells as well as cancer cells.

"So we wanted to develop a method whereby we could retarget the virus
to infect cancer cells only," he said. "And we succeeded."

The measles virus normally takes control of healthy cells, but researchers
re-engineered it to attack only diseased ones. Laboratory mice were given
human ovarian and lymphoma cancer cells. They developed measurably
visible tumors. Mice were then given anti-cancer virus. Tumors either
shrank or disappeared.

"When I saw the data, I was completely stunned. It`s the sort of thing that,
having worked on targeting viruses for about 15 years, I just couldn`t
believe that we`d finally got what we`d been hunting all that time," said
Russell.

Researchers reprogrammed the measles virus to bind to cancer cells instead
of normal binding sites. A "molecular tag" on the virus was a key
innovation. It`s the first time mass production of anti-cancer virus was
possible, Russell said.

Viruses normally infect by binding to a cell, fusing membranes with it,
entering and taking over, the clinic says. Russell said researchers can now
pick which measles receptor to target on cells "and send the virus after it."

"What we are now doing is we are generating a spectrum of targeted
measles viruses that recognize different cancer cells," he said. Work now
centers on brain, liver, multiple myeloma, ovary and pancreas cancer.

It will be "at least two years" before even an early-stage clinical trial can
begin with humans, he said. "I would anticipate that 10 years from now,
this would be another weapon that could be used for the treatment of
cancer," Russell said, though much work remains to be done.

[r.schaui]

#muycaro

das hilft oncolytics nicht weiter.
auffällig ist, dass seit jahren klinische tests laufen, ohne dass ergebnisse bekannt gegeben werden.

der kurs gerät nicht umsonst die letzten monate unter druck

ich kann nur hoffen, dass demnächst positive meldungen - testergebnisse - kommen

mfg
r.schaui

[muycaro]

r.schaui

Klinische Tests brauchen Zeit. Vorallem wenn es bei dem Medikament um einen Virus handelt.
Zunächst muss die Höchstdosis ermittelt werden, daher auch die "dose escalation trials" die derzeit stattfinden.
Bei Reolysin ist es schwierig eine Höchstdosis zu ermitteln, da es bisher keinerlei stärkeren Nebenwirkungen gezeigt hat, auch nicht bei 1000-fach grösseren Dosen als noch zu Beginn verabreicht.

Und diese Artikel helfen Oncolytics sehr wohl, da sie die Validität der Plattform verifizieren und das öffentliche Interesse (Investoren, Finanzinstitutionen wie Fonds, etc.), bzw. das der Pharmakonzerne auf sich lenken.
Sobald diese davon überzeugt davon überzeugt sind, dass die Virologie der nächste grosse Schritt neben den "small molecules" in der Krebstherapie ist, wird jeder versuchen ein Stück vom Kuchen abzubekommen.

Das wiederum würde jede Menge Geld und Kompetenz für die schnellere Ausweitung der Versuchsreihen bereitstellen, etc.

Und der Kurs von Oncolytics ist nunmal News gesteuert (wie jeder andere Biotech Wert auch), mal abgesehen davon sind wir von den Tiefs immer noch 300% im Plus.

Was sollen sie grossartig dagegen machen - irgendeine News veröffentlichen, die eigentlich nicht notwendig wäre?
Wäre etwas negatives im Royal Marsden passiert, sprich SAEs (severe adverse effects), hätten sie das längst melden müssen. No news is good news in diesem Fall.

Ich habe auch meine Probleme von Zeit zu Zeit Geduld zu haben, aber mir ist klar, dass es noch einige Zeit dauern kann bis Ergebnisse veröffentlicht werden.

Solltest Du diese Geduld nicht aufbringen können, rate ich Dir zu verkaufen und Dein Geld woanders arbeiten zu lassen (ich nehme gerne noch ein paar, so wie gestern).


Viele Grüsse, muy

[r.schaui]

hallo muycaro

ich habe die geduld (meistens) und mir fehlt auch nicht der glaube,
meine bekommst du nicht, bleibe long seit synsorb

mfg
r.schaui

[r.schaui]

#muycaro,

es tut übrigens immer gut deine sachlich fundierten und optimistischen statements zu lesen

schönes wochenende

r.schaui

[muycaro]

r.schaui

Jeder zweifelt ab und zu mal, inklusive mir.
Wie oft habe ich Emails an die IR geschrieben um zu versuchen denen Beine zu machen.
Mittlerweile leitet Cathy meine Mails immer direkt zu Brad weiter - bin wohl ein unangenehmer "Kunde".
Nachdem ich etliche Mails mit Brad ausgetauscht habe, bin ich zu der persönlichen Erkenntnis gekommen, dass die Versuchsreihen und vorher festgelegte Prozeduren/Abläufe eben eine gewisse Komplexität haben und man nichts erzwingen kann. Auf meine und die Anregungen anderer Aktionäre baut Oncolytics seine FAQ (frequently asked questions) jetzt immer mehr aus.

Ich hätte auch gerne Ergebnisse und das sobald wie möglich - ist ja klar. Ich denke auf die Marsden Ergebnisse werden wir noch mindestens bis Mitte dieses Jahres warten müssen (kann auch länger dauern - who knows).
Was mit den Ergebnissen des Glio Trials ist weiss wohl keiner so genau.

Am Ende kann man sich nur auf das stützen was man schon hat, sprich die Ergebnisse der Phase I Studie, die schon veröffentlicht wurden (erst von Oncolytics und zuletzt nochmal detaillierter von einer Kollegin von Dr. Morris mit einer anderen Sichtweise - Psychologie).
Ich selbst bin erstaunt, dass wir schon mit diesen subobtimalen Dosen, die anfänglich aus Sicherheitsgründen dem Zehntel der wirksamen Dosis die einer Maus verabreicht wurde, derlei Erfolge erzielen konnen.


Sicherheit: scheint kein grosses Thema zu sein von dem was wir bisher gesehen haben (keine schweren Nebenwirkungen auch bei 1000 fachen Dosen - vergleiche mit Chemo, Bestrahlung oder "small molecules", die alle eine x-fach höhere Toxizität haben).


Wirksamkeit: kann derzeit noch schwer beurteilt werden, da zuwenige Daten vorliegen, bzw. keine Kontrollgruppe (Placebo, wäre in diesem Fall konventionelle Chemotherapie) existiert die eine statistische Signifikanz nachweisen könnten.
Allerdings ist das Schrumpfen der Tumore schon mal interessant zu sehen, auch in dieser nicht optimalen Ausgangslage.
Es wurde ein Field Effekt beobachtet, d.h. auch Metastasen, die sich nicht unmittelbar an der Injektionsstelle befanden wurden von dem Virus attackiert - das lässt hoffen einer Therapie gegen metastasierenden Krebs einen Schritt näher gerückt zu sein.


Vergleiche veröffentlichte Phase I vs. Phase I Marsden:

Phase I = suboptimale Dosis,
Marsden = bessere Dosierung dank Erfahrungswerten und Sicherheitsprofil

Phase I = intratumorale Injektion (regional + zeitlich begrenzt)
Marsden = intravenöse Infusion, sprich besser für den Patienten, da Infusion nicht schmerzhaft wie intratumoral, Virus kann sich über einige Zeit direkt über die Blutbahn verbreiten und an Ras aktivierte Krebszellen andocken.

Wiederholte Nachbehandlungen:
Phase I = nicht möglich, auch nicht wenn erfolgreich und der Patient danach verlangte - ausschliesslich eine einzige Injektion in suboptimaler Dosis.
Marsden = Weitere Infusionen möglich, je nach Erfolg/Bedarf vom behandelnden Arzt zu entscheiden (es wurden laut Oncolytics Management bereits Re-Treatments durchgeführt).

To be continued...

Vielleicht siehst Du auf was ich hinaus will - die Marsden Ergebnisse werden erst wirklich zeigen welches Potential in Reolysin steckt.
Wegen den Timelines kann ich Dir nur sagen, dass Brad mir mitgeteilt hat, dass sobald es keine "dose escalation trials" mehr sind, also die sichere und wirksame Dosis bestimmt ist, sie einen Zeitplan vorgeben werden, dies so sagte er mir, wäre derzeit unmöglich.

Ich meinte das mit dem, dass Du Deine Position überdenken solltest, wenn Du Dir zu unsicher bist Ernst. Es ist oft keine Schande auf sein Bauchgefühl zu hören.
Oncolytics ist ein hochspekulativer Baby-Bio Wert.
Die Volatilität ist hoch, das Handelsvolumen schwankt ebenfalls sehr stark und sie "verbrennen" Geld (obwohl sie davon wohl erstmal genug haben sollten).
Man sollte sich dem Risiko bewusst sein, dass hier auch ein Totalverlust nicht ausgeschlossen ist, sollten alle Stricke reissen. Will heissen, man sollte nur so viel riskieren, wie man auch bereit ist zu verlieren, bzw. man sollte noch ruhig schlafen können.
Ebenfalls braucht man viel Geduld - Oncolytics ist eben nicht Coca Cola, die mal eben ne neue Werbekampagne starten können und dadurch bessere Ergebnisse erzielen - hier lässt sich nichts erzwingen.
Ich selbst besitze eine sehr grosse Position (zumindest für meine Verhältnisse), daher ist meine Meinung sehr subjektiv, also hör lieber auf Dich selbst oder andere nicht Investierte, wenn Du Dir unsicher bist.

Ich wünsche Dir viel Glück, allen anderen natürlich auch, und hoffe dass "in der nicht allzu fernen Zukunft" (Lieblingszitat von unserem CEO) einige Antworten auf uns warten.

Bis dann, muy

P.S.: Netter Turnaround gestern und heute...

[merx]

...to 2.84+/- million shares.
www.secinfo.com/$/SEC/Filing.asp?D=1v81.zm-*-CIK=64782



jetzt hat Mellonbank 2.840.000 Shares von Oncy..........


Gruß

merx

[muycaro]

Die Deutsche Bank hat mittlerweile eine, wenn auch sehr kleine, Position aufgebaut:

Owner Name
Select a name below for more information. Date Shares Held Change
(Shares) % Change
(Shares) Value
($1000)
MELLON FINANCIAL COR... 12/31/2004 2,584,811 - - $10,055

MELLON BANK N A 9/30/2004 2,184,183 880,125 67.49% $8,496

AMARANTH ADVISORS LL... 12/31/2004 500,475 500,475 New $1,947

BANKMONT FINANCIAL C... 12/31/2004 81,329 9,485 13.20% $316

DEUTSCHE BANK AG 12/31/2004 17,673 17,073 >1,000.00% $69


http://www.nasdaq.com/asp/holdings.asp?mode=&kind=&symbol=ON…


Hier noch eine interessante neue Entwicklung in Kanada bezueglich der Forschungen mit oncolytischen Viren:



`Virus guys` take aim at killing cancer

Tom Spears
CanWest News Service

Wednesday, February 16, 2005


A half-million dollar gift from a Mississauga executive will equip the Ottawa Regional Cancer Centre to test viruses that infect and destroy cancer cells while leaving healthy cells alive.

"We plan to make this the place in Canada to make small batches of viruses and test them in people," said John Bell, a senior researcher at the centre.

Bell plans to bring together at least five sets of Canadian researchers who are experimenting with cancer-killing viruses.

"The idea is to work together so we don`t duplicate, but also to compare and contrast these viruses so we see which works best under which conditions. The reality is that we don`t care which one it is. We just want to get something out there."

The new grant, provided by Brennan Mulcahy, president of Energy Savings Group, will allow researchers to set up a testing facility in Ottawa.

"The reason I`m excited about this is that we got a grant from the Terry Fox Foundation to set up a consortium of guys across Canada, all with different viruses," said Bell, adding that in a few years his team will likely be able to manufacture any one of these viruses and test them very quickly.

The "virus guys" are more formally known as the Canadian Oncolytic Virus Consortium.

Bell said all groups share a common approach: they`re engineering different viruses to enter a person`s body and kill only cancer cells.

"It`s performing really well in mice and in the test tube (on human cells), and we`ve discovered new parts about it that we hadn`t appreciated before," he said.

One virus being studied enters cancer cells, hijacks the cell`s own internal machinery to manufacture thousands of new viruses, which move on to kill nearby cancer cells. But it can`t infect healthy cells.

The first phase of human testing will start in about a year. Patient volunteers will be chosen after the Ottawa cancer centre sends word to doctors on how to enroll.

Members of the Cancer Study Group

- Canadian Oncolytic Virus Consortium: Ottawa Regional Cancer Centre, University of Ottawa

John Bell (consortium director), Harry Atkins, Earl Brown, Glen Goss

- Tom Baker Cancer Centre, University of Calgary

Peter Forsyth, Don Morris

- Lady Davis Research Centre, McGill University

John Hiscott, Nahum Sonenberg, Wilson Miller, Gerry Batist

- Robarts Research Institute, University of Western Ontario

Grant McFadden

- Hamilton Regional Cancer Centre

Sebastien Hotte

This story features a factbox "Members of the cancer study group".

© The Calgary Herald 2005

[muycaro]

News (Reolysin + Bestrahlungstherapie in England):

Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Inc. Announces Approval for U.K. Clinical Trial Investigating REOLYSIN(R) in Combination with Radiation Therapy
Friday February 18, 2:01 am ET


CALGARY, Feb. 18 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX: ONC, NASDAQ: ONCY) announced today that it has received a letter of approval from the U.K. regulatory authorities (Medicines and Healthcare products Regulatory Agency or MHRA) for its Clinical Trial Application (CTA) to begin a Phase I clinical trial to evaluate the feasibility, safety and anti-tumour effects of intratumoural administration of REOLYSIN(R) in combination with radiation in patients with advanced cancers. The Principal Investigators are Dr. Kevin Harrington of the Cancer Research U.K. Centre for Cell and Molecular Biology, The Institute of Cancer Research, London, and Dr. Alan Melcher of the Cancer Research U.K. Clinical Centre at St. James`s University Hospital in Leeds. The trial will enroll patients at the Royal Marsden and St. James`s Hospitals in the U.K.
ADVERTISEMENT


"In animal models, radiation therapy used in combination with REOLYSIN(R) had more effect than either agent by itself." said Dr. Brad Thompson, President and CEO of Oncolytics. "This clinical trial will be the first to examine the effects of intratumoural delivery of REOLYSIN(R) in combination with radiation."

The trial is a Phase I open-label, dose-escalation study of REOLYSIN(R) combined with two different radiation dosages/schedules. The enrolment in this study is expected to be approximately thirty evaluable patients, and will depend upon the number of dose levels tested. Up to an additional fifteen patients will also be treated at the maximum tolerated dose (MTD). The primary objective of the study is to determine the MTD, dose limiting toxicity (DLT), and safety profile of REOLYSIN(R) when administered intratumourally to patients receiving radiation treatment. A secondary objective is to examine any evidence of anti-tumour activity. Patients who have been diagnosed with advanced or metastatic solid tumours that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists will be eligible.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN(R), its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN(R) was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN(R).

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company`s expectations related to patient enrolment and the results of the UK Phase I trial investigating delivery of REOLYSIN(R) in combination with radiation and the Company`s belief as to the potential of REOLYSIN(R) as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN(R) as a cancer treatment, the success and timely completion of clinical studies and trials, the Company`s ability to successfully commercialize REOLYSIN(R), uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.


http://biz.yahoo.com/prnews/050218/to250_1.html

[muycaro]

Sieht gut aus heute an der TSE (+>10%). Da die meisten Warrants heute verfallen, sollte sich der Verkaufsdruck etwas legen. Wird sich noch bestaetigen muessen, wenn morgen die Nasdaq wieder zu handeln beginnt. Die naechsten Warrants liegen im Bereich $6,25 (kanadische Dollars).

Ein neues Dokumente:



Title:
Connecting Reovirus Oncolysis and Ras Signaling

Author(s):
Paola Marcato, Maya Shmulevitz and Patrick W. Lee
PDF Coming Soon Vol: 4 | Issue: 4 | april 2005 | pgs: NA | Perspectives


Abstract:

Reovirus is a benign virus with innate oncolytic activity and is a potential novel therapeutic for a number of cancers. Reovirus can replicate in, and induce death of cancerous cells having an activated Ras pathway. Ras activation leads to the inactivation of cellular antiviral mechanisms, specifically removing the translation block on reovirus transcripts. This review outlines recent progress towards elucidating the molecular connection between the Ras-signaling pathway and reovirus replication.

http://www.landesbioscience.com/journals/cc/abstract.php?id=…


Thread eines englischen, medizinischen Selbsthilfe-Boards - evtl. beobachten:

http://www.breastcancercare.org.uk/Chat/Forums/Secondarybrea…

[r.schaui]

und hier noch eine aktuelle einschätzung zum entwicklungsstand bei oncy:

SUBJECT: Some questions...some answers Posted By: proboscis
Post Time: 2/21/05 18:11
« Previous Message Next Message »

1. Comment/Question from oldfox21: "...I see the opposite and wonder why we are still pursuing monotherapy(which apparently is less efficacious) in the Canadian glio trials and Marsden systemic trials. Unless it`s to establish a base line."
My answer: The first thing needed to satisfy regulators in the approval process is a demonstration of safety. This is the primary purpose of phase I trials. The clearest way to demonstrate the safety of a new product is through monotherapy - using the new therapy alone so as not to confound the results with the influence of any other therapy. Therefore, the first phase 1 trials of REOLYSIN (each for a different mode of administration) have all been conducted as monotherapies - intra-tumoral, intra-cerebral, systemic. These trials are not an unnecessary dalliance. They are a necessary first step. Also, each of the three mentioned modes of administration have great applicability for different types of cancer - intra-tumoral injections for solid accessible tumors, intra-cerebral administration for brain cancers (so as to circumvent the blood-brain-barrier), and systemic administration for inaccessible or metastatic cancers. Each mode of administration: 1. broadens the applicability of REOLYSIN, 2. provides options for the quickest route to approval, and 3. increases the prospects of negotiating a good partnership agreement with big pharma. Finally, I reject the suggestion that monotherapy in the glio and systemic trials is proving ineffective. I would argue that the lack of negative news, the re-treatments, and the recently announced contract with Cobra for additional REOLYSIN are all suggestive of positive safety and efficacy.

Here`s one comment from Brad (October 22, 2003) regarding the necessary stepwise and cautious clinical approach (Stockhouse post #6838076):

"With respect to clinical development, we’re staging our way into different routes of delivery through our whole clinical program. And again, in the viral area one tends to start out cautiously because it is an infectious disease. So one moves from local deliveries, what we call intra-tumoral or local deliveries, and works your way eventually into large systemic studies. And it’s a stepwise planned program in all the companies that you’ll see that engage in this area."

2. Comment/Question from Chief: "So is this "good news" or much like any other flailing Canadian Biotech, things are not going that well in Marsden and a previously known combination is now all of a sudden vaulted to the forefront. I find it highly suspicious that an obvious direction was not taken until a trail update (Marsden) is about to be announced."

My answer: Yes, the announced reovirus + radiation trial is good news. Oncolytics is not "flailling" - they are following a well thought-out and clearly articulated strategy. The Marsden systemic trial is proceeding, the trial has been expanded to St. George`s, retreatments are occuring, and Cobra has a new contract for additonal REOLYSIN - all indicators of positive results in my opinion. Re. the combination therapy (reo + radiation), I don`t believe it`s suddenly "vaulted to the forefront" (as if the other trials are no longer considered important). The reo + radiation trial is one more promising and welcome trial in a strategy that will include a number of important trials - intra-cerebral infusion (glio), combination therapy with reo + radiation (UK), and reo + chemo (NCI - this could involve chemo in combination with intra-tumoral OR systemically injected REOLYSIN - we don`t know yet), on-going systemic (this could lead to further systemic monotherapy trials, or it could lead to a systemic trial in combination with immunosuppression, or chemo, or radiation. The versatility of the reovirus makes possible many different approaoches, and the strategy of Oncolytics is to pursue the most promising approaches. To limit the field to only one appraoch is premature, foolish, and unneccesary. Oncolytics` stated goal has always been to achieve a favourable partnership agreement with big pharma at the most optimum time (in terms of shareholder return). They are having ongoing conversations with potential partners and regulators, and IMO they are in a much better position to determine the best strategy (as opposed to armchair quarterbacks). Finally, ONC never said they would give an update of the Marsden trial. Here is what Brad said at the 2004 AGM (Stockhouse post #7955784):

"13. Re. the Marsden trial he said, "It will be done when it is done. Any timeline would be inaccurate." He stressed that the pathway to regulatory approval is not specific/not cookie cutter consistent. The pathway varies with every filing. (My comment: Getting a therapy approved is not a predictable process like making widgets. Many unique occurances and requests happen that uniquely (and unpredictably) shape the progress of the therapy through development). It was asked if there would be interim results from the Marsden trial. Brad answered, "It depends."


Here is my view of Oncolytic Biotech`s strategy:

1. Focus on reovirus (with a secondary interest in other oncolytic viruses that target the ras pathway) - clearly stated and also evidenced by their patent coverage.

2. Patent all potentially valuable intellectual property. Also, be careful not to release information prematurely, which could jepardize intellectual property - clearly stated, evidenced by their multilayered omnibus patents, and demonstrated by their practice of releasing minimal clinical trial information.

3. Pursue indications/modes of administration that hold promise of fast approval, and that most interest potential pharma partners - clearly stated in annual reports, quarterly reports, interviews, etc.

4. Be thorough and accomodating in meeting the requests of the regulators (do things right and stay in the good books of the regulators). As Brad said at the 2004 AGM: "6. Last year`s comment re. it being more important to do the glio trial "right" (correct) rather than fast. Brad said he would be happy with "correct AND fast", but he will not sacrifice correct for speed" (Stockhouse post #7955784).

5. always maintain sufficient cash so as not to be squeezed by potential partners, and so as to be able to sustain a robust phase I and II clinical trial program. (Here is a bit from an interview with Brad on WorldTalkRadio - October 26, 2003 - Stockhouse post #7001336:

Brad: Well we currently have a little over 20 million Canadian in the bank, accessible to us. And our burn rate is estimated over the next couple of years to be in the sort of $700,000 Canadian a month range. So we have cash that takes us into Q2 06, which is nice. We’ve been fortunate in being able to raise money. The key issue for us has been to ensure we had enough capital to reach all the critical milestones we are expecting in 04, and then having a cushion beyond that. We’ve never planned on taking this product into late stage clinical studies by ourselves. The plan has always been to get five or six early studies done and then partner up with one of the tier one oncology programs in the big pharmas, and then work on the product together beyond that. We just wanted to make sure that we had the financial resources, that we had the financial strength behind us that enabled us to go into those kinds of negotiations and discussions from a secure base. I think we’ve accomplished that.

WorldTalkRadio: Yeah, so they can’t squeeze you.

Brad: Yeah, and they’re very good at that. I have a lot of colleagues in big pharma and they don’t like to pay any more than they have to for things, and if you’re running short of resources they’ll wait. Of course they will. That’s just good business, I applaud them for that. Then at least if you know that’s what they are planning on doing you can take steps to ensure that that won’t happen to you.

6. Partner some time before starting phase III trials (at a time most advatageous to ONC shareholders) - clearly stated on multiple occassions (like the quote above), plus in annual and quarterly reports, etc.

mfg
r.schaui

[muycaro]

Die schon erwarteten News (mehr Cash durch Ausuebung der Warrants/Optionen aus frueheren Financings. Zusammenfassung: in der nahen Zukunft keine weiteren Financings, Cash fuer 3 Jahre bei der derzeitigen Burnrate):

Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Inc. Receives $3.25 Million in Proceeds From Warrants Issued on August 21, 2003

Tuesday February 22, 2:20 pm ET


CALGARY, Feb. 22 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) (`Oncolytics`) today announced that it has received total proceeds of $3,254,132 with respect to the exercise of 813,533 warrants from the private placement entered into on August 21, 2003. Of the total proceeds, $178,244 was received prior to the end of September 2004, and included in the Company`s quarterly reports.

With the inclusion of the warrant proceeds, the Company estimates it has adequate cash on hand to fund its expected operations for approximately three years. With current cash on hand, Oncolytics does not expect to enter into additional financings in the near future.

As at the close of business on February 21, 2005 there were 32,684,468 common shares issued and outstanding.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN(R), its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN(R) was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN(R).

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company`s expectations relating to the adequacy of its financial resources to fund the development of its business through 2007 and its expectations regarding the potential need for additional financings in the near future, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, uncertainties relating to the Company`s anticipated clinical trial program and development activities, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward- looking statements. The Company does not undertake to update these forward- looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/prnews/050222/to028_1.html

[muycaro]

Termin im Maerz:

5th Annual EC21 BioVentures
The Future of BioVenture Investing:
Biotechnology, Informatics, Medical Devices and Healthcare Services
March 22-23, 2005 • London, England • QEII Conference Centre

http://www.techvision.com/ec21/participants/

[muycaro]

News: Oncolytics bekommt die FDA Freigabe für klinische Versuchsreihen in den USA (Malignant Meloma = aggressive Form von Gehirntumoren) - haben wir lange drauf gewartet - NCI next?:

Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Receives FDA Clearance to Initiate Phase I/II Recurrent Malignant Gliomas Clinical Trial
Monday February 28, 8:15 am ET


CALGARY, Feb. 28 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX: ONC, NASDAQ: ONCY) announced today that it has received clearance from the US Food and Drug Administration (FDA) to begin a Phase I/II clinical trial to investigate the use of REOLYSIN(R) to treat patients with recurrent malignant gliomas. The principal investigator for the trial is Dr. James Markert, Professor, Neurosurgery and Physiology, the University of Alabama at Birmingham.

"Treatment of specific cancers, such as brain cancer, with local or regional administration of REOLYSIN(R) is part of Oncolytics` clinical strategy," said Dr. Brad Thompson, President and CEO of Oncolytics. "The U.S. study will complement our Canadian recurrent malignant gliomas study by employing an alternative method of product delivery to the tumour site in the brain."

This clinical trial is an open-label dose escalation Phase I/II study in which a single dose of REOLYSIN(R) will be administered by infusion to patients with recurrent malignant gliomas that are refractory to standard therapy. The administration involves the stereotactically-guided placement of a needle into the tumour, through which REOLYSIN(R) will be administered or infused into the tumour mass and surrounding tissue using a pump. The primary objective of the study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT) and safety profile of REOLYSIN(R). Secondary objectives include the evaluation of viral replication, immune response to the virus and any evidence of antitumour activity. The enrolment in this study is expected to be up to 30 evaluable patients in the dose escalation phase with up to an additional 14 patients added at the maximum tolerated dose ("MTD").

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN(R), its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN(R) was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN(R).

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company`s expectations related to the results of the Canadian and US Phase 1/II trials investigating delivery of REOLYSIN(R) for recurrent malignant gliomas, and the Company`s belief as to the potential of REOLYSIN(R) as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN(R) as a cancer treatment, the success and timely completion of clinical studies and trials, the Company`s ability to successfully commercialize REOLYSIN(R), uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/prnews/050228/to121_1.html

[heidi00]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[merx]

http://biz.yahoo.com/prnews/050304/to266_1.html

Gruß
merx

[Bombenleger]

Oncolytics Biotech Inc. Announces Issuance of 2nd European Patent
Monday July 18, 8:30 am ET
- Continues to Strengthen Intellectual Property -


CALGARY, July 18 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) ("Oncolytics") has been granted European Patent 1,309,672 entitled "Method of Producing Infectious Reovirus." The claims relate to a method of producing infectious mammalian reovirus which is suitable for clinical administration to mammals including humans.
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"This patent is consistent with our strategy to continue to expand and strengthen our portfolio of intellectual property worldwide," said Dr. Matt Coffey, Chief Scientific Officer for Oncolytics. "Along with our clinical trial and collaborative research programs in Europe, the United States and Canada, these patents are a key component of our development strategy for REOLYSIN®."

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, prostate, pancreatic, bladder and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

This news release contains forward looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements, including among others, the Company`s belief as to the safety and efficacy of the reovirus, the Company`s expectations as to the potential applications of the patented technology and other statements relating to anticipated developments in the Company`s business and technologies, involve known and unknown risks and uncertainties that could cause the Company`s actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward looking statements. The Company does not undertake to update these forward looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

[muycaro]

Versuchsreihe zur Kombinationstherapie mittels Bestrahlung/Reovirus hat begonnen:

Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Inc. Commences Patient Enrolment in U.K. Clinical Trial Investigating REOLYSIN(R) in Combination with Radiation Therapy
Tuesday July 26, 2:01 am ET


CALGARY, July 26 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX: ONC, NASDAQ: ONCY) announced today that it has commenced patient enrolment in its U.K. clinical trial investigating REOLYSIN® in combination with radiation therapy as a treatment for patients with advanced cancers.
The Principal Investigators are Dr. Kevin Harrington of the Cancer Research U.K. Centre for Cell and Molecular Biology at The Institute of Cancer Research, London, and Dr. Alan Melcher of the Cancer Research U.K. Clinical Centre at St. James`s University Hospital in Leeds. The trial will enroll patients at the Royal Marsden and St. James`s Hospitals in the U.K.

The trial is a Phase I open-label, dose-escalation study of REOLYSIN® combined with two different radiation dosages/schedules. The enrolment in this study is expected to be approximately thirty evaluable patients, and will depend upon the number of dose levels tested. Up to an additional fifteen patients will also be treated at the maximum tolerated dose (MTD). The primary objective of the study is to determine the MTD, dose limiting toxicity (DLT), and safety profile of REOLYSIN® when administered intratumourally to patients receiving radiation treatment. A secondary objective is to examine any evidence of anti-tumour activity. Patients who have been diagnosed with advanced or metastatic solid tumours that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists will be eligible.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, bladder, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company`s expectations related to patient enrolment and treatment and the results of the UK Phase I trial investigating delivery of REOLYSIN® in combination with radiation and the Company`s belief as to the potential of REOLYSIN® as a cancer therapeutic, alone, or in combination with other therapies, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, the Company`s ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.


http://biz.yahoo.com/prnews/050726/to201.html?.v=7

[r.schaui]

hallo muycaro,
schön, nach so langer zeit wieder von dir zu hören.

bemerkenswert finde ich auch folgendes aus yahoo und stockhouse:

As already discussed on this message board and on the Yahoo message board, reovirus enters all cells (both normal and cancer cells) but only replicates in RAS activated cancer cells. Normal cells are not RAS activated, so reovirus does not replicate in normal cells and is removed from those cells through normal cellular processes.

2/3 of all cancers are RAS acitvated.

To date clinical trials using ONC/Ys reovirus have demonstrated that there are no significant side effects (no SAEs) with reovirus in the treatment of cancer. If side effects were to be seen they should have been seen when reovirus was administered intravenously in the Royal Marsden systemic clinical trials. None have been reported. So it is very probably now that no side effects will be reported in the future also.

What is important to also understand is that only cancer cells produce a mucin barrier.

This mucin barrier acts as a defense for the cancer cells and it is generally impenetrable to chemotherapy drugs and to the body`s normal immune system.

Recent studies that only reovirus can penetrate this mucin barrier, thus creating a pathway for the chemotherapy drugs and natural lymphocytes to kill the weakened cancer cell. This is now the logic behind the effective use of reovirus in combination with either low dose chemotherapy or low dose radiation.

mfg
r.schaui

[muycaro]

Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Inc. Announces Appointment of Chief Medical Officer
Tuesday September 27, 7:00 am ET


CALGARY, Sept. 27 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX: ONC, NASDAQ: ONCY) announced today the appointment of Karl Mettinger, MD, PhD, as Chief Medical Officer.
"Dr. Mettinger has been involved with the clinical and regulatory approval of oncology, cardiovascular, and other products in the pharmaceutical industry for twenty years," said Dr. Brad Thompson, President and CEO of Oncolytics. "His record includes the implementation of clinical studies for more than 25,000 patients worldwide. As part of our senior medical and scientific management group which includes Dr. Gill and Dr. Coffey, Dr. Mettinger is expected to develop the clinical trial program which best supports a registration path for REOLYSIN®."

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Dr. Mettinger has been involved in clinical and regulatory affairs with various pharmaceutical companies since 1985. Prior to joining Oncolytics, he was Senior Vice President and Chief Medical Officer with SuperGen Inc. Prior to that, he was Executive Director, Clinical Research at IVAX/Baker Norton, which is the new drug subsidiary of IVAX Corporation. He began his career in the industry with KABI in Sweden. Dr. Mettinger holds an MD from the University of Lund in Sweden and a PhD (hematology/stroke) from the Karolinska Institute in Stockholm, Sweden. He is a member of numerous medical and scientific associations including the American Association of Clinical Oncology, the American Society of Hematology and the American Association of Cancer Research.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, bladder, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the impact Dr. Mettinger will have on the development towards a registration path, the Company`s expectations related to the advancement of REOLYSIN through the clinical and regulatory process, and the Company`s belief as to the potential of REOLYSIN® as a cancer therapeutic, alone, or in combination with other therapies, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, the Company`s ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/prnews/050927/to121.html?.v=12

[muycaro]

US-Versuchsreihe gestartet (erster Patient behandelt):

Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Inc. Begins Patient Enrolment in U.S. Systemic Delivery Clinical Trial
Wednesday September 28, 8:30 am ET


CALGARY, Sept. 28 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX: ONC, NASDAQ: ONCY) announced today that it has started patient enrolment in its U.S. clinical trial investigating the systemic delivery of REOLYSIN® as a treatment for patients with advanced or metastatic solid tumours.


The Principal Investigator for the trial is Dr. Sanjay Goel, Assistant Professor and Attending Physician in the Department of Medical Oncology, Montefiore Medical Center and Albert Einstein College of Medicine, New York City.

This clinical trial is an open-label, dose-escalation Phase I study in which a single dose of REOLYSIN® will be administered intravenously to patients diagnosed with selected advanced or metastatic solid tumours that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists. The enrolment in this study is expected to be up to thirty six evaluable patients and will depend in part upon the number of dose levels tested. The primary objective of the study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT) and safety profile of REOLYSIN®. Secondary objectives include the evaluation of viral replication, immune response to the virus and any evidence of anti-tumour activity.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics` researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in vitro, kill human cancer cells that are derived from many types of cancer including breast, bladder, prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN® was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company`s expectations related to the results of the US Phase I trial investigating systemic delivery of REOLYSIN®; the Company`s belief as to the nature of the market opportunity that REOLYSIN® is intended to address; and the Company`s belief as to the potential of REOLYSIN® as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, the Company`s ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals, competitive risks associated with research and development initiatives of the Company`s competitors, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

http://biz.yahoo.com/prnews/050928/to147.html?.v=12

[r.schaui]

hallo muycaro,

oncy hat uns ganz schön geduld abverlangt,
nach den meldungen der letzten tage scheinen die versuchsreihen insbesondere in marsden aber sehr erfolgreich zu verlaufen. in den stockhouse und yahoo boards wird vermutet, dass eventuell noch in diesem jahr positive ergebnisse veröffentlicht werden.

stay long

mfg r.schaui

[r.schaui]

sieht so aus, als gibt es erste ergebnisse

Börse NASDAQ

Aktuell 3,60 USD

Zeit 28.09.05 21:24

Diff. Vortag +25,87 %

Tages-Vol. 1,29 Mio.

Gehandelte Stück 392.592

r.schaui

[MONSIEURCB]

Heute +15%...ich denke, wir überschreiten gerade eine historische Schwelle: Der wissenschaftlichen Öffentlichkeit (aund auch der Börse) wird klar, dass Reosin TATSÄCHLICH funktioniert...bin gespannt, wann die Tenbagger-Gier-Welle einsetzt....

[r.schaui]

die historische schwelle wurde allerdings bereits mehrfach überschritten. was neu ist, dass oncy heute angekündigt hat, im november ergebnisse zu präsentieren:

"CALGARY, Oct 05, 2005 /PRNewswire-FirstCall via COMTEX/ -- Oncolytics Biotech Inc.
("Oncolytics") (CA:ONC)(ONCY) announced today that presentations covering various
REOLYSIN(R) research programs will be made at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics: Discovery, Biology, and
Clinical Applications, to be held November 14 to 18 in Philadelphia, Pennsylvania.
A poster entitled `A Phase I study of a wild-type reovirus (Reolysin) given
intravenously to patients with advanced malignancies` will be presented by Dr.
Johann S. de Bono of The Royal Marsden Hospital and The Institute of Cancer Research,
UK, and a poster entitled `Reovirus enhances radiation cytotoxicity in vitro and in vivo`
will be presented by Dr. Kevin J. Harrington of the Targeted Therapy Laboratory,
The Institute of Cancer Research, Cancer Research UK Centre for Cell and Molecular Biology,
UK. "

mfg
r.schaui

[r.schaui]

ich kann mir eigentlich nicht vorstellen, dass koryphäen der krebsforschung ergebnisse präsentieren, die nicht gut sind, ich erwarte eher, dass wir im november sehr gute ergebnisse zu erwarten haben

mfg
r.schaui

[MONSIEURCB]

Genau DAS meinte ich ja... ,-)

[js200]

RAiDAR alerts Learn More About RAiDAR-LT


10/05/2005 (12:26 ET) ONCY: Filed New Form 6-K, Foreign Material Event Report - Edgar



10/05/2005 (10:55 ET) ONCY: Volume Spike; 13% > 20-adsv, Stock +13.03% - Knobias



10/05/2005 (07:07 ET) Oncolytics Biotech`s Research Collaborators to Present Data on REOLYSIN(R) Research at AACR-NCI-EORTC Conference - Canada NewsWire



10/05/2005 (07:00 ET) Oncolytics Biotech`s Research Collaborators to Present Data on REOLYSIN(R) Research at AACR-NCI-EORTC Conference - PR Newswire



10/05/2005 (02:01 ET) Oncolytics Biotech`s Research Collaborators to Present Data on REOLYSIN(R) Research at AACR-NCI-EORTC Conference - Canada NewsWire



10/05/2005 (02:01 ET) Oncolytics Biotech`s Research Collaborators to Present Data on REOLYSIN(R) Research at AACR-NCI-EORTC Conference - PR Newswire



10/04/2005 (08:02 ET) ONCY: To Present At Sachs-Bloomberg Conference @ 06:40 ET - Knobias



09/30/2005 (10:20 ET) ONCY: Volume Spike; 9% > 20-adsv, Stock -8.54% - Knobias



09/29/2005 (11:44 ET) ONCY: Filed New Form 6-K, Foreign Material Event Report - Edgar



09/29/2005 (10:15 ET) ONCY: Volume Spike; 18% > 20-adsv, Stock +5.36% - Knobias



09/29/2005 (07:32 ET) Oncolytics Biotech Inc. to Present at the Sachs-Bloomberg 5th Annual Biotech in Europe Investor Forum - Canada NewsWire



09/29/2005 (07:30 ET) Oncolytics Biotech Inc. to Present at the Sachs-Bloomberg 5th Annual Biotech in Europe Investor Forum - PR Newswire



09/28/2005 (16:22 ET) ONCY: Jumps +8.12%; Vol +74%; Last 90 Min of Trading - Knobias



09/28/2005 (12:55 ET) ONCY: Filed New Form 6-K, Foreign Material Event Report - Edgar



09/28/2005 (11:40 ET) ONCY: Volume Spike; 24% > 20-adsv, Stock +9.63% - Knobias



09/28/2005 (08:34 ET) ONCY: Begins Patient Enrolment in U.S. Systemic Delivery Clinical Trial - Knobias



09/28/2005 (08:33 ET) ONCY: Commences Patient Enrolment in U.S. Systemic Delivery Clinical Trial - Knobias



09/28/2005 (08:31 ET) Oncolytics Biotech Inc. Begins Patient Enrolment in U.S. Systemic Delivery Clinical Trial - Canada NewsWire



09/28/2005 (08:30 ET) Oncolytics Biotech Inc. Begins Patient Enrolment in U.S. Systemic Delivery Clinical Trial - PR Newswire



09/27/2005 (13:30 ET) ONCY: Filed New Form 6-K, Foreign Material Event Report - Edgar



09/27/2005 (08:08 ET) Oncolytics Biotech Inc appoints new Chief Medical Officer - M2 Communications



09/27/2005 (07:06 ET) Oncolytics Biotech Inc. Announces Appointment of Chief Medical Officer - Canada NewsWire



09/27/2005 (07:00 ET) Oncolytics Biotech Inc. Announces Appointment of Chief Medical Officer - PR Newswire



09/27/2005 (02:01 ET) Oncolytics Biotech Inc. Announces Appointment of Chief Medical Officer - Canada NewsWire



09/27/2005 (02:01 ET) Oncolytics Biotech Inc. Announces Appointment of Chief Medical Officer - PR Newswire

[merx]

http://www.aacr.org/default.aspx?p=4255


Gruß

merx

[r.schaui]

ohne eine nachricht

Börse NASDAQ

Aktuell 4,17 USD

Zeit 11.10.05 20:19

Diff. Vortag +8,88 %

Tages-Vol. 724.191,43

Gehandelte Stück 174.773

mfg
r.schaui

[js200]

Last Trade: 4.140 Change: 0.310 (+8.094%)
Previous Close: 3.830 Volume: 186,500
Bid: 4.130 Ask: 4.170
Today`s Open: 3.940 # of Trades: 249

[js200]

10/07/2005 (12:01 ET) ONCY: Filed New Form 6-K, Foreign Material Event Report - Edgar
10/07/2005 (08:30 ET) Oncolytics Biotech Inc. Announces Issuance of Second Canadian Patent - Canada NewsWire
10/07/2005 (08:30 ET) Oncolytics Biotech Inc. Announces Issuance of Second Canadian Patent - PR Newswire
10/06/2005 (08:07 ET) LiquidStockReport.com: Aggressive Stock Trader Alert - M2 Communications
10/05/2005 (16:17 ET) Stocks Tank Despite Oil Below $63; S&P Hits 3-Month Low - Knobias

[merx]

Auszug vom Yahoo-Bord

this quarter - active phase 2 program
Later this quarter - 4-6 phase 2 programs
challenge to decide on which phase 2`s
Systemic - initiating 2nd part
early studies - witrh the tumor burden across the body, hard to assess response rates, response rate overrated
Cdn Glioma - January results announced, ph 2 = radiation combo
UK systemic - very very responsive + pre approved treatment on MTD
PH 1 UK combo completed this quarter
Adenovirus - have figured out how to make it RAS active
1 mm Cdn per month - 32 mm$$ 18 mos money in hand


guter Tag heute...............


m e r x

[js200]

10/20/2005 (14:32 ET) ONCY: To Present At Bio InvestorForum Conference @ 16:20 ET - Knobias
10/20/2005 (11:07 ET) ONCY: Filed New Form 6-K, Foreign Material Event Report - Edgar
10/20/2005 (08:34 ET) Oncolytics Biotech Inc. Announces Issuance of Third Canadian Patent - Canada NewsWire
10/20/2005 (08:30 ET) Oncolytics Biotech Inc. Announces Issuance of Third Canadian Patent - PR Newswire
10/20/2005 (08:03 ET) SessionsIR.com: Andrx claims exclusive generic marketing rights for Cardizem LA high blood pressure drug: TTMT, ONCY, ADRX, BVF, ABT - M2 Communications

[merx]

http://www.myalgia.com/overview2.htm

Ist dies in Marsden ebenfalls Gegenstand von Versuchsreihen ???

Dr.Bono wird uns am 14.11.05 Antwort geben.

imho

m e r x

[r.schaui]

auszug aus dem yahoo board zur rückbildung von tumoren nach verabreichung von reolysin:

Interesting Tumour Regression
by: bridger48 (M/Washington State)
Long-Term Sentiment: Buy 11/03/05 06:26 am
Msg: 56415 of 56416

From Dr. Thompson`s San Francisco Talk:

"This is a very bad [photo in presentation]. As my investigator for the study said: “I’m not a photographer Brad, I’m a doctor.” This is an early patient. An interesting hallmark of local therapies with this virus is that you get responses of some form at all dosage levels. It seems to be dosage independent. This patient got actually the second lowest dosage of the virus in that study and about two weeks later the tumour on her neck had completely flattened out. That red mark is just a punch biopsy spot. What I find interesting, and this is again a hallmark of this particular product, is you could have rated this as a partial response. The tumour stabilized and it never grew back. But you always have this underlying mass often left over that when you biopsy, you find there is no neoplastic tissue left in it anymore. So you might see anywhere from between a 30 and 70 or 80 percent tumour “regression”, and when you biopsy the tumors, you find there is nothing left there, that it has stabilized. So, imaging becomes an issue with these types of products. What’s left over often isn’t what you think it is. It’s certainly an area of focus for us, for future imaging studies."

Highlights

1) "An interesting hallmark of local therapies with this virus is that you get responses of some form at all dosage levels."

2) "This patient got actually the second lowest dosage of the virus in that study and about two weeks later the tumour on her neck had completely flattened out."

3) "The tumour stabilized and it never grew back. "

4) "What’s left over often isn’t what you think it is"

5) "So you might see anywhere from between a 30 and 70 or 80 percent tumour “regression” and when you biopsy the tumors, you find there is nothing left there that it has stabilized."

mfg
r.schaui

[merx]

Auszug aus London Free Press:

http://lfpress.ca/newsstand/News/Local/2005/11/17/1310423-su…

Gruß

merx

[js200]

Stockwire.com: The Movers and Shakers Blog, Part 1:

Monday , November 21, 2005 09:01 ET

MIAMI, Nov 21, 2005 (M2 PRESSWIRE via COMTEX) -- We like stocks trading big dollar value volume! A very interesting indicator to look for is where the money is flowing into. We have a filter that we watch every morning that shows us "Dollar Volume". We also like stocks that are trading at bargain prices. As of 10:30AM, a couple of these stocks are: (NASDAQ: PANL), (NASDAQ: ALVR), (OTCBB: JSDA), (NASDAQ: ONCY)

To feature your publicly traded company in our alerts, email us at [e-mail]

For the nine months ended 30 September 2005, Universal Display Corporation`s revenues increased 48% to $7.9M. Net loss decreased 10% to $11.2M. Revenues reflect improved performance of contract research and development chemical segments. Lower loss also reflects decreased operating loss due to lower cost of chemicals sold and increased interest income. The Company is engaged in the research & development of organic emitting diode technology.

For the nine months ended 30 September 2005, Alvarion Ltd.`s, revenues rose 2% to $149.2M. Net loss totaled $8.7M vs. an income of $7.6M. Revenues reflect an increase in product sales. Net loss reflects increased research & development expenses, increased selling & marketing expenses, increased general & administrative expenses, increased amortization of intangibles and decreased financial income.

For the nine months ended 30 September 2005, Jones Soda Co.`s revenues increased 21% to $25.4M. Net income decreased 44% to $703K. Revenues reflect improvement in the direct to retail relationship and penetration of new markets in the core direct store distribution business. Net income was offset by higher cost of sales, increased promotion & selling expense, higher general & administration expense and increased depreciation.

For the nine months ended 30 September 2005, Oncolytics Biotech Inc.`s revenues increased 26% to C$624K. Net loss fell 1% to C$8.8M. Revenues reflect an increase in interest income due to higher cash balances. Net loss reflects increased research & development expenses, increase in amortization expense and lower gain on sale of BCY Lifesciences Inc. Oncolytics is engaged discovery and development of pharma products.

As a trader, a very intelligent place to put your money, is where the money is flowing into. When you get into stocks that are trading millions of dollars within the first 30-60 minutes of the market being open, chances are you will be able to get out of your position without hurting the stock. These are the kind of trades that you want to get into.

As the saying goes...follow the money!

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As of Thursday, 11-17-2005 23:59, the latest Comtex SmarTrend(SM) Alert,
an automated pattern recognition system, indicated a DOWNTREND on
07-05-2005 for ALVR @ $9.14.

As of Thursday, 11-17-2005 23:59, the latest Comtex SmarTrend(SM) Alert,
an automated pattern recognition system, indicated an UPTREND on
09-28-2005 for ONCY @ $3.18.

As of Thursday, 11-17-2005 23:59, the latest Comtex SmarTrend(SM) Alert,
an automated pattern recognition system, indicated an UPTREND on
11-07-2005 for PANL @ $11.32.

(C) 2005 Comtex News Network, Inc. All rights reserved.

[MONSIEURCB]

Die 5 Dollar sind geknackt....x-mas-rallye, here we come!

[r.schaui]

vom yahoo board

PRNewswire: Reovirus Destroys Cancer
by: moonthruclouds (M/Calgary)
Long-Term Sentiment: Strong Buy 12/05/05 08:22 am
Msg: 58745 of 58800

Reovirus Seeks Out and Destroys Cancer Cells, Preliminary Study Results Show

CALGARY, Alberta, Dec. 5 /PRNewswire/ -- For the first time, researchers ave demonstrated that the reovirus, a naturally occurring virus found in the nvironment, can seek out and destroy cancer cells in a variety of tumor types nd locations when delivered intravenously to patients.

Preliminary results from an ongoing patient study in the United Kingdom ave demonstrated that Reolysin was well-tolerated by patients and there was vidence of virus replication within several types of tumors in patients who had failed all previous treatments. Of 12 patients who received doses of Reolysin on five consecutive days, at least four patients had stabilization of the measured tumor. Patients who experienced tumor activity included those with colorectal, prostate, non-small-cell lung and bladder cancers.

These early results, presented by Dr. Johann S. de Bono of the Royal Marsden Hospital in London at the most recent AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia, showed that the reovirus, when delivered intravenously, enters cancer cells, replicates within them and ultimately kills them. It works by replicating within cancer cells that have an activated Ras pathway, a common mutation that is shared by approximately two thirds of all human cancers.

"We believe that these early results are the most encouraging data we have seen to date in our work with Reolysin," says Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc., the company sponsoring the study. Oncolytics has also started patient enrolment in a similar intravenous trial in the United States at the Montefiore Medical Center in New York City. This clinical trial is an open-label, dose- escalation Phase I study in which a single dose of Reolysin is administered intravenously to patients with advanced and/or metastatic solid tumors.

mfg
r.schaui

[r.schaui]

die meldung wurde offiziell von oncolytics nicht bestätigt, hat aber ausgereicht, die aktie heute um mehr als 10 % bei hohen umsätzen steigen zulassen.

mfg
r.schaui

[merx]

von der FDA

http://www.fdanews.com/dailies/dpa/3_237/news/49250-1.html


Gruß

merx

[r.schaui]

sehr viel beachtung scheint oncy hier nicht zu haben,
dabei sind die ergebnisse mehr als viel versprechend

nachweis mehrerer phase I studien über absolute sicherheit und effektivität des anti krebs virus reolysin

in einer testreihe mit 12 personen, bei denen kein anderes mittel mehr anschlug, hat reolysin in mindestens 4 fällen den krebs besiegt

noch im dezember will oncy den fahrplan für 2006 bekannt geben, geplant sind 4 - 6 Phase II studien gegen mehrere arten von krebs

der kurs der aktie ist unter hohem volumen in der letzten woche um mehr als 20 % gestiegen

mfg
r.schaui

[merx]

Hallo Oncy fans,

UBS is still buying............

Long and strong


O n c y


merx

[r.schaui]

neues zu oncolytics from yahoo:

CALGARY, Alberta, Feb. 21 /PRNewswire/ --

Medical studies show that a common virus may be able to eliminate cancer cells from autologous stem cell transplants.

Researchers at Calgary-based Oncolytics Biotech Inc., have patented a way to use the reovirus to purge cancer cells from autologous stem cell transplants that are reintroduced to the body following high-dose chemotherapy. Autologous transplantation following high-dose chemotherapy is a proven treatment alternative for many types of cancer and is extensively used by doctors for both solid tumours and tumours of the blood. In fact, autologous blood and bone marrow transplant procedures surpass the number of transplants derived from donors.

During the procedure, blood stem cells are extracted from a patient prior to high-dose chemotherapy. Once the chemotherapy is completed, the patient`s own blood stem cells are transplanted back into the patient. The primary advantage of autologous transplants is that there is no risk of rejection.

However, it has been estimated that as many as 30 per cent of these autologous stem cell transplants are contaminated by cancer cells, and there is a risk that they may contribute to clinical relapse of the cancer by reintroducing cancer cells back into the body.

"If we can use our reovirus-based therapy, Reolysin to purge the blood products of cancer cells before they are reintroduced to the body, it could represent an important step forward in increasing the success of these transplants," says Dr. Matt Coffey, Chief Scientific Officer for Oncolytics.

When introduced to the blood, the reovirus enters cancer cells, replicates within them and ultimately kills them. It works by replicating within cancer cells that have an activated Ras pathway, a common mutation that is shared by approximately two thirds of all human cancers. The results of a study to purge cancer cells from autologous stem cell preparations using the reovirus were previously published in the March 13, 2003 issue of Blood. Researchers concluded that the use of reovirus may be an effective way to purge cancer cells in blood used for ex-vivo autologous stem cell transplants.

The link to reovirus` cancer-killing ability was established after it was discovered that it reproduces well in various cancer cell lines including those found in blood cancers. "Having an effective method to purge cancer cells from autologous blood stem cell transplants may offer doctors another important tool in fighting cancer," said Dr. Coffey. "Patenting this innovation provides us with an important extension of the potential use of the reovirus for the treatment of cancer."


mfg
r.schaui

[r.schaui]

oder auszugsweise eine horror übersetzung in deutsch

Oncolytics Biotech Inc. verkündet Austeilung von 14. VEREINIGTEN STAATEN patentieren

London, Februar 7
Verteilt durch PR Newswire im Namen Oncolytics Biotech Inc.


CALGARY, Kanada, Februar 7/PRNewswire/--

- Reovirusabstand der Ras-Vermittelten neoplastischen Zellen von zellularem gemischtaufbau

Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) ("Oncolytics") ist das STAATPATENT bewilligt worden 6.994.858, das erlaubt wird "Reovirusabstand der Ras-Vermittelten neoplastischen Zellen von zellularem gemischtaufbau.", Die Ansprüche beschreiben Methoden des Verwendens des Reovirus ex Vivo, um das Verschmutzen der Krebszellen von den autologous (geerntet vom Patienten selbst) Blutstammzelletransplants zu beseitigen. Die Resultate einer Studie zum Bereinigen Krebszellen von den autologous Stammzellevorbereitungen, die das Reovirus verwenden, wurden vorher im März 13, Ausgabe 2003 von Blut veröffentlicht.

"die Resultate dieser Studie zeigten, daß das Reovirus eine Rolle zum Spielen haben kann, wenn es verschmutzende Krebszellen von den Stammzellevorbereitungen bereinigt, die für Transplants benutzt werden," sagten Dr. Matt Coffey, wissenschaftlicher hauptsächlichoffizier für Oncolytics. "dieses Patent versieht Oncolytics mit einer wichtigen Verlängerung des möglichen Gebrauches des Reovirus für die Behandlung des Krebses.",

Folgende Hochdosis-Chemotherapie der hämatologischen (abgeleitet vom Blut) Stammzelle-für Rettung wird weitgehend klinisch beide feste Tumors und Tumoren des Bluts verwendet. Global übertrifft die Zahl des autologous Bluts und die Knochenmarktransplants die Zahl Spender-abgeleiteten Transplants. Es ist daß so viel geschätzt worden, wie 30 Prozent dieser autologous Stammzelletransplants durch Krebszellen verschmutzt werden, und kann zum klinischen Rückfall des Krebses beitragen.

mfg
r.schaui

[r.schaui]

Transmitted by CNW Group on : January 24, 2006 02:01
Oncolytics Biotech Inc.`s Research Collaborators to Present Phase I Combination REOLYSIN(R)/Radiation Clinical Trial Data at AACR Conference
CALGARY, Jan. 24 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC,
NASDAQ:ONCY) announced today that an oral presentation covering preliminary
results of its Phase I combination REOLYSIN(R)/radiation clinical trial will
be made at the American Association of Cancer Researchers (AACR) annual
meeting, to be held April 1-5 in Washington, D.C. The presentation, entitled
"Phase I trial of intratumoral administration of reovirus type 3 (Reolysin) in
combination with radiation in patients with advanced malignancies" will be
delivered by Principal Investigator Dr. Kevin J. Harrington of the Targeted
Therapy Laboratory, The Institute of Cancer Research, Cancer Research UK
Centre for Cell and Molecular Biology and Honorary Consultant in Clinical
Oncology at The Royal Marsden NHS Foundation Trust, London, UK.

r.schaui

[r.schaui]

oncolytics steigt den 5. tag in folge

und vom 1. - 5. april veröffentlicht dr. harrington die ergebnisse der phase I der marsden klinik united kingdom

r.schaui

[muycaro]

Abstracts der Präsentationen auf der AACR:



Abstract Number: 3998

Presentation Title: Phase I trial of intratumoral administration of reovirus type 3 (Reolysin) in combination with radiation in patients with advanced malignancies

Presentation Start/End Time: Tuesday, Apr 04, 2006, 11:40 AM -11:55 AM

Location: Room 150, Washington Convention Center

Author Block: L Vidal, K Twigger, C L. White, M Ahmed, H S. Pandha, C M. Nutting, J S. De Bono, S B. Kaye, A Melcher, K J. Harrington. Royal Marsden Hospital, Sutton, United Kingdom, Institute Cancer Research, London, United Kingdom, St Georges Hospital, London, United Kingdom, St James Hospital, Leeds, United Kingdom

Background: Reoviruses are RNA viruses that replicate preferentially in cells with aberrant Ras-pathway signaling. In vitro and in vivo data have shown that the combination of reovirus (REO) and radiation (RT) significantly increases RT-induced cytotoxicity.
Material and Methods: Patients (pts) with measurable or evaluable disease amenable to treatment with localised short-course palliative radiotherapy with electrons or orthovoltage X-rays were enrolled in cohorts of 3. Treatment consisted in local tumour irradiation to a dose of 20 Gy in 5 consecutive daily fractions in combination with two intratumoural injections of Reolysin on days 2 and 4 at the following dose-escalation levels: 108, 109 and 1010 tissue culture infectious dose (TCID50). Endpoints were safety, detection of viral replication, evaluation of immune response and antitumoral activity.
Results: Six pts have been treated to date (4M/2F) with the following tumor types: metastatic oesophageal cancer to supraclavicular lymph node, metastatic melanoma to skin, abdominal recurrence of pancreatic cancer, recurrent skin squamous carcinoma, metastatic ovarian cancer to skin and locally advanced parotid tumor. One patient at the 1 x 109 dose could not receive the second REO injection due to grade 3 fatigue and grade 2 flu-like symptoms. Other toxicities have been mild (grade 1-2) and have included fever, sweating, skin erythema. There has been no evidence of exacerbation of the acute radiation reaction. Reverse transcription polymerase chain reaction (RT-PCR) studies of blood, urine, stool and sputum on day 8 post-REO administration were negative for viral shedding for all treated pts. Data from neutralising anti-REO antibodies and cellular immune response pre- and post-treatment are being evaluated. Two pts (oesophageal and skin squamous carcinoma) have had significant partial responses (70% and 50%) at 2 and 1 months, respectively, after treatment. In addition, the pt. with metastatic oesophageal cancer had a volume reduction of 15% in the non-irradiated mediastinal disease. Intratumoral viral replication is currently being evaluated by electron microscopy and immunohistochemistry of pre- and post-treatment tumour biopsies.Conclusions: The combination of intratumoral REO and radiation is well tolerated. Local responses and early indicators of systemic effect have been observed. Recruitment is ongoing



Abstract Number: 1137

Presentation Title: Molecular evaluation of reovirus purging of mantle cell lymphoma in autologous transplants

Presentation Start/End Time: Sunday, Apr 02, 2006, 1:00 PM - 5:00 PM

Location: Exhibit Hall, Washington Convention Center

Poster Section: 11
Poster Board Number: 2

Author Block: Chandini M. Thirukkumaran, Jason Spurrell, Mark Pho, Huong Muzik, Tommy Alain, Gwyn Bebb, Don Morris. Tom Baker Cancer Centre, Calgary, AB, Canada, University of Calgary, Calgary, AB, Canada

Introduction: Mantle Cell Lymphoma (MCL) is a B-cell non-Hodgkin lymphoma (NHL) characterized by a t(11:14) translocation causing over expression of cyclin D1 and cell-cycle dysregulation. MCL is considered incurable with conventional chemotherapy and even with high-dose chemotherapy and autologous hematopoietic stem cell transplantation. Evidence supports occult tumor cells within autografts leading to relapse and underscores the need for effective purging strategies to rid these tumor cells from the autografts. We have previously shown reovirus, a double stranded RNA virus to be oncolytic towards a myriad of neoplasms with minimal effects on stem cells (Blood. 2003;102(1):377-387). The aim of the present study was to evaluate the purging efficacy of MCL cell lines by reovirus using molecular detection methods.
Methods/Results: Human MCL cell line JVM2 was grown to 50-60% confluency and 104 cells in 20 ìl (per well) were dispensed in a 96- well plate. Cells were infected with reovirus (serotype 3, strain dearing) or with reovirus infectious sub viral particles (ISVP) at a multiplicity of infection (MOI) of 40 or 80 in a total of 10ìl at 4°C for 45 min. Following the addition of 140 ìl of RPMI 1640 medium with 10% FCS the plates were incubated at 37°C. 0, 2, 4 and 7 days following reovirus infection, WST-1 reagent was added to the cells and assayed for cell proliferation and viability at absorbance at 450nm using a plate reader. Marked cytopathic effects were observed with reovirus treatment and cell viability decreased significantly with reovirus treatment. Further, SDS PAGE of JVM2 cells infected with 35S labeled reovirus indicated cleavage of virus µ1 protein as early as 12 hours confirming reovirus susceptibility. In order to assess efficacy of purging of JVM2 by reovirus, we quatitated minimal residual disease via a nested PCR assay. Apheresis product was admixed with JVM2 cells in ratios ranging from 1: 106- 106: 106 and total RNA was extracted using Trizol and reverse transcribed to cDNA. Nested PCR was performed with primers directed against the major translocation cluster region to detect the bcl-1 breaks. The present nested PCR protocol was able to detect 1: 106 of JVM2 cells in apheresis cells. Admixtures of apheresis cells with JVM2 cells (0.1% and 0.01%) are currently being purged with reovirus. Purging efficacy will be assessed following RNA extraction of these cells.



Abstract Number: 4331

Presentation Title: Reolysin®, an unmodified Reovirus, has significant anti-tumor activity in childhood sarcomas.

Presentation Start/End Time: Tuesday, Apr 04, 2006, 1:00 PM - 5:00 PM

Location: Exhibit Hall, Washington Convention Center

Poster Section: 24
Poster Board Number: 9

Author Block: Wendong Ellen Zhang, E. Anders Kolb. Albert Einstein College of Medicine, Bronx, NY

Reolysin® is an unmodified oncolytic reovirus which replicates selectively in ras transformed cells causing cell lysis. Activating mutations in ras or mutations in oncogenes signaling through the ras pathway may occur is as many as 80% of human tumors. Such mutations have been described in many of the common sarcomas of childhood.
In the currently study, ras activation is confirmed in several Ewing’s sarcoma, rhabdomyosarcoma, synovial sarcoma, and osteosarcoma cell lines. In vitro cytotoxicity assays reveal complete cell kill at reovirus titers greater than 1 to 10 pfu for all cell lines tested. A cytopathic effect is observed by microscopy and viral replication assessed by immunoprecipitation of vrial protein in whole cell lysates.
The ani-tumor effect of the reovirus is confirmed in vivo using established xenograft models of pediatric sarcomas. Initial experiments using reovirus doses of 1 x 108 pfu, 5 x 108 pfu and 5 x 109 pfu daily for 3 days per week times 2 weeks, reveal that the 5 x 109 pfu dose is well tolerated and effective in the nude mice xenograft model of osteosarcoma. The antitumor effect of the reovirus is subsequently evaluated in 4 additional independent pediatric sarcoma xenografts (Ewing’s sarcoma and rhabdomyosarcoma, respectively). In all tumor lines evaluated, the reovirus exhibits significant antitumor activity, including a complete response in a rhabdomyosarcoma line. Relosysin® demonstrates excellent anti-tumor activity in vitro and in vivo in childhood sarcoma cell lines. These promising preclinical results suggest that a clinical trial of systemic reovirus in pediatric solid tumors is warranted.



Abstract Number: 4217

Presentation Title: Mutant KRAS promotes apoptosis of Reovirus-infected colorectal tumor cells without affecting virus replication

Presentation Start/End Time: Tuesday, Apr 04, 2006, 1:00 PM - 5:00 PM

Location: Exhibit Hall, Washington Convention Center

Poster Section: 7
Poster Board Number: 3

Author Block: Niels Smakman, Diana Van den Wollenberg, Rob Hoeben, Inne Borel Rinkes, Onno Kranenburg. UMC Utrecht, Utrecht, The Netherlands, Leiden University Medical Center, Leiden, The Netherlands

Reovirus T3D is an oncolytic agent that preferentially targets tumor cells with ‘an activated Ras pathway’. It has been proposed that RAS-dependent Reovirus replication determines cellular sensitivity to Reovirus T3D oncolysis. Here we show that the mutation status of the RAS gene in both human and mouse colorectal cancer (CRC) cell lines does not predict their sensitivity to Reovirus T3D. Reovirus replication was observed in all cell lines tested regardless of RAS status. Furthermore, neither Reovirus T3D protein synthesis, nor T3D virus yields were affected by deletion of an endogenous mutant KRAS allele by homologous recombination or by expression of short-hairpin RNAs targeting the mutant RAS allele. Rather, reovirus-induced tumor-cell apoptosis was strongly reduced upon deletion of the mutant RAS allele. Similarly, deletion of TP53 reduced apoptosis induction by Reovirus, whereas deletion of mutant â-catenin had no effect. Mutant KRAS- or TP53-deficient cells displayed reduced sensitivity to oxaliplatin, but not to death receptor activation by TNF-related apoptosis-inducing ligand (TRAIL). We conclude that sensitization of tumor cells to Reovirus-induced apoptosis underlies the RAS-dependency of Reovirus T3D oncolysis in both human and mouse CRC cell lines.

[muycaro]

Press Release Source: Oncolytics Biotech Inc.


Oncolytics Biotech Inc. Phase I Combination REOLYSIN(R)/Radiation Clinical Trial Abstract Available on AACR Website
Friday March 3, 1:31 pm ET


CALGARY, March 3 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) announced today that an abstract covering the preliminary results of a Phase I combination REOLYSIN®/radiation clinical trial being conducted in the U.K. is available today on the American Association for Cancer Research (AACR) website at www.aacr.org, and on the Oncolytics website at www.oncolyticsbiotech.com. The abstract is entitled "Phase I trial of intratumoral administration of reovirus type 3 (Reolysin) in combination with radiation in patients with advanced malignancies."
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"Early results of the study show that patients are experiencing local and systemic responses to the combination of REOLYSIN® and radiation treatment," said Dr. Matt Coffey, Oncolytics` Chief Scientific Officer. "We are pleased with these initial indications of activity, and look forward to providing an update of interim study results at the AACR annual meeting."

An oral presentation covering more detailed interim results of the Phase I combination clinical trial is scheduled to be delivered at the AACR annual meeting which runs April 1-5 in Washington, D.C. The presentation will be delivered by Principal Investigator Dr. Kevin J. Harrington of the Targeted Therapy Laboratory, The Institute of Cancer Research, Cancer Research UK Centre for Cell and Molecular Biology and Honorary Consultant in Clinical Oncology at The Royal Marsden NHS Foundation Trust, London, UK.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics` clinical program includes a variety of Phase I and Phase I/II human trials using REOLYSIN®, its proprietary formulation of the human reovirus, alone and in combination with radiation. For further information about Oncolytics, please visit www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the implication of the abstract and materials presented on the AACR website and at this meeting with respect to REOLYSIN®, the Company`s expectations related to the results of trials investigating delivery of REOLYSIN®, and the Company`s belief as to the potential of REOLYSIN® as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company`s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, the Company`s ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company`s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech Inc.

[r.schaui]

hallo muycaro

schön nach so langer zeit von dir mal wieder zu hören

du hast dich sehr rar gemacht und oncy hat uns lange zeit auf die folter gespannt

die ergebnisse sind mehr als gut, oncy wird uns noch sehr viel freude machen

r.schaui

[merx]

Press Release Source: Oncolytics Biotech


Reovirus Could Be Used to Treat Many Forms of Advanced Cancer
Thursday June 8, 5:06 am ET


CALGARY, Alberta, June 8 /PRNewswire/ -- An experimental drug called Reolysin® may give hope to patients suffering from advanced cancers, according to research presented at this year's meeting of the American Society of Clinical Oncology (ASCO) -- the oncology community's premier educational and scientific event.
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In a world first, 30 patients received various intravenous dosages of Reolysin in a Phase I trial in the United Kingdom. The results demonstrated that Reolysin may have stopped the growth of tumors in some patients, or even shrunk tumors without the side effects normally associated with more traditional forms of cancer therapy.

"This is a really novel concept in cancer therapy," said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics Biotech Inc. "Billions of particles of Reolysin, derived from the naturally occurring reovirus, were administered daily to cancer patients who had failed all other cancer therapies, or for whom no viable cancer treatments exist," he said. "The results demonstrated anti-tumor activity in patients with colorectal, prostate, pancreatic, bladder and non-small cell lung (NSCL) cancers."

Two colorectal patients had tumor stabilization at three and six months, and CEA reduction (a cancer marker) of 27% and 60% respectively. One patient with metastatic prostate cancer had stable disease at four months, with a 50% reduction in PSA (prostate specific antigen), and extensive tumour cell death. One patient with metastatic bladder cancer had stable disease at four months, with a minor tumor response in a metastatic lymph node lesion. A patient with NSCL cancer and a pancreatic cancer patient also each had stable disease at four months.

The study has demonstrated that when the virus invades a Ras-activated cancer cell, it proceeds to replicate until it kills the host tumor cell. When the cancer cell dies, thousands of progeny virus particles are released, which proceed to infect and kill adjacent cancer cells. But normal cells are unharmed by reovirus infection.

More recently, a secondary immune response has been observed after reovirus treatment. Researchers believe that once the reovirus infects a cancer cell, it may educate the immune system to recognize and kill that type of cancer cell. "But there is still more to be learned about this remarkable virus," said Dr. Coffey.

A similar intravenous trial being conducted at the Montefiore Medical Center in New York is expected to wrap up later this year. Other trials are expected to follow in the U.K. and the U.S., including two trials sponsored by the U.S. National Cancer Institute (NCI) which will include a Phase II trial for melanoma patients, and a Phase I/II trial for ovarian cancer patients.

For more information, log on to http://www.oncolyticsbiotech.com.




--------------------------------------------------------------------------------
Source: Oncolytics Biotech

[DrAljechin]

Hallo Muycaro,r.schaui,

die Kursentwicklung von oncy ist enttäuschend !

Schätze mal die Aktie geht erst so richtig ab,wenn in Phase 3 angekommen,aber wieviel Zeit wird bis dahin vergehen ? Habe die Aktie auf der watchlist und werde in Phase 3 einsteigen,wie lange wird das wohl noch dauern,muycaro? 2 Jahre ? 5 Jahre ? Im moment ist mit Gilead Sciences mehr Geld zu verdienen,aber Oncy wird irgendwann der renner ...

MFG

Dr.A

[reguau]

Antwort auf Beitrag Nr.: 22.236.102 von DrAljechin am 23.06.06 07:39:55

hallo al

ich bin besorgt über die über gebühr lange entwicklungszeit und die bisher vom ceo nie eingehaltenen ansagen

oncy forscht seit ca 6 jahren und ist über phase I bisher nicht hinaus gekommen

zudem sagt der ceo seit zwei jahren unaufhörlich unmittelbar bevorstehende phasen II an, passiert ist jedoch nichts

ich teile die zweifel im yahoo board, ob das management in der lage ist, reolysin zur markteinführung zu bringen

reguau alias r.schaui

[DrAljechin]

Hallo reguau alias r.schaui,

Bist du drin in oncy ? Ich war drin vor einigen Jahren ,als oncy von 5 auf 10 US-$ gestiegen war! Ich hatte ja gedacht die 10 $ würden halten aber dem war nicht so .Aus den aktuellen News bei oncy entnehme ich,das die in Phase "1a" angekommen sind,was auch immer das heissen mag,jedenfalls immer nocht nicht Phase 2 Wie lange soll das denn noch dauern,bis die mal zu Potte kommen ??? Ich glaube ich mache keinen Fehler,wenn ich oncy weiterhin auf der Watchlist belasse und dann gegebenenfalls in Phase 3 einsteige! Dass auch in Phase 3 noch genug schiefgehen kann ,sieht man ja ganz gut an Dendreon,aber trotzdem würde ich ein spielchen wagen ,sollte oncy bis Phase 3 vorwärtzkommen !
Die Mcap von Dendreon liegt aktuell bei 300 Mio.-US$,gegenüber ca.150 Mio bei oncy in Phase 1.Vergleicht man beide Werte ,könnte man auf die Idee kommen dass auch oncy bei ca.300 Mio.US-$ stehen würde,wenn sie in Phase 3 angekommen sind !Das wären vom jetzigen Kursniveau aber nur "magere" 100% und wer weiss wie viele Jahre wartezeit.Das lohnt sich IMHO erst mal nicht.Ich werde noch einige Jahre in gute Rohstofftitel drinbleiben und dann wieder nach oncy schauen,ganz bestimmt ...

MFG

Dr.A

[DrAljechin]

P.S.Reguau,was hälst du von Genemax auf aktuellem Niveau ?

[reguau]

Antwort auf Beitrag Nr.: 22.295.517 von DrAljechin am 27.06.06 12:42:01

ich bin drin, seit synsorb

mein anteil an biotechs ist gedeckt, an anderen habe ich derzeit kein interesse

danke trotzdem für deinen tip

reguau

[reguau]

phase II ---- endlich ----

CALGARY, July 18, 2006 /PRNewswire-FirstCall via COMTEX/ -- Oncolytics Biotech Inc. ("Oncolytics") (CA:ONC:, USA:ONCY : oncolytics biotech inc com)

Financials:ONCY (2.51, -0.22, -8.1%) announced today that it has received a letter of approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for its Clinical Trial Application (CTA) to begin a Phase II clinical trial to evaluate the anti-tumour effects of intratumoural administration of REOLYSIN(R) in combination with low-dose radiation in patients with advanced cancers.

"Oncolytics will initiate this Phase II trial based on the promising safety and clinical responses observed in our Phase Ia REOLYSIN(R)/radiation trial," said Dr. Brad Thompson, President and CEO of Oncolytics. "In the Phase Ia trial, partial tumour responses were observed in a number of patients and the product was well-tolerated."

The trial is an open-label, single-arm, multi-centre Phase II study of REOLYSIN(R) delivered via intratumoural injection to patients during treatment with low-dose radiotherapy. Up to 40 evaluable patients, including approximately 20 patients with head and neck and esophageal cancers, and approximately 20 patients with other advanced cancers, will be treated with two intratumoural doses of REOLYSIN(R) at 1x10(10) TCID(50) with a constant localized radiation dose of 20 Gy in five consecutive daily fractions. Eligible patients include those who have been diagnosed with advanced or metastatic cancers including head, neck and esophageal tumours that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists.

The primary objective of the trial is to assess the anti-tumour activity of the combination of REOLYSIN(R) and low dose radiotherapy in treated and untreated lesions. Secondary objectives include the evaluation of viral replication, immune response to the virus and to determine the safety and tolerability of intratumoural administration of REOLYSIN(R) in patients with advanced cancers who are receiving radiation treatment.

[DrBlackburne]

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[reguau]

Antwort auf Beitrag Nr.: 22.804.981 von reguau am 20.07.06 12:17:04

nachdem oncy seine aktionäre nach langen jahren des bangens, wartens und hoffens am 18. juli dieses jahres mit dem eintritt in eine phase II erlöst hat, scheint jetzt auch der kurs zu reagieren.

Börse NASDAQ

Aktuell 2,80 USD

Zeit 14.08.06 18:52

Diff. Vortag +12,58 %

Gehandelte Stück 51.850

ist das jetzt nur eine technische reaktion auf die talfahrt des kurses seit april diesen jahres oder steckt mehr dahinter?

im yahoo board herrscht merkwürdiges schweigen

reguau

[reguau]

Antwort auf Beitrag Nr.: 23.443.272 von reguau am 14.08.06 19:22:42

CALGARY, Aug 23, 2006

12:22am 08/23/2006

ONCY is pleased to announce that it has completed patient enrolment in its Phase I U.S. clinical trial investigating the systemic delivery of REOLYSIN(R) to treat patients with advanced cancers. A total of 18 patients were treated in the Phase I trial with REOLYSIN(R) at escalating dosages of 1x10(8), 3x10(8), 1x10(9), 3x10(9), 1x10(10) or 3x10(10) TCID(50). A maximum tolerated dose (MTD) was not reached and the treatment appears to have been well tolerated by the patients.
The clinical trial is an open-label, dose-escalation Phase I study in which a single dose of REOLYSIN(R) was administered intravenously to patients diagnosed with selected advanced or metastatic solid tumours that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists. The primary objective of the study is to determine the MTD, dose limiting toxicity and safety profile of REOLYSIN(R). Secondary objectives include the evaluation of viral replication, immune response to the virus and any evidence of anti-tumour activity.
The principal investigator for the trial is Dr. Sanjay Goel, Assistant Professor and Attending Physician in the Department of Medical Oncology, Montefiore Medical Center and Albert Einstein College of Medicine, New York City.

[reguau]

Antwort auf Beitrag Nr.: 23.577.963 von reguau am 23.08.06 14:49:52

und hier eine übersicht der einzelnen phasen:

Delivery Method Cancer Indication Location Status
Local therapy in combination with radiation Phase II various metastatic tumours, including head & neck U.K. Approval to commence
Local therapy in combination with radiation Phase I various metastatic tumours U.K. Phase Ia complete
Phase Ib ongoing
Infusion monotherapy Phase I/II recurrent malignant gliomas U.S. Ongoing
Intravenous administration monotherapy Phase I various metastatic tumours U.S. Ongoing
Intravenous administration monotherapy Phase I various metastatic tumours U.K. Ongoing
Local monotherapy Phase I recurrent malignant gliomas Canada Complete
Local monotherapy T2 prostate cancer Canada Complete
Local monotherapy Phase I trial for various subcutaneous tumours Canada Complete

[merx]

9/8/2006 2:00:00 AM ET News Release Index


Oncolytics Biotech Inc. Research Collaborators to Present Reovirus Research at European National Societies of Immunology

CALGARY, AB, --- September 8, 2006 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced that a poster by A. Melcher et al of the Cancer Research U.K. Clinical Centre, Leeds, UK, Institute of Cancer Research, London, UK, University of Surrey, Guildford, U.K. entitled “Reovirus Activates Dendritic Cells (DC) and Promotes Innate Anti-Tumour Immunity” will be presented tomorrow, September 9, 2006 at the 1st Joint Meeting of European National Societies of Immunology. The meeting is being held from September 6-9, 2006 in Paris, France.

“These results are exciting as they suggest that in addition to direct cancer cell killing, the reovirus may assist the immune system in fighting cancer cells,” said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics.

The poster highlights the researchers' use of isolated human cells to examine whether the use of the reovirus as a direct tumour killing agent might also activate the innate immune system to play a role in the killing of tumour cells. The innate immune system is the broad, short-term and non-specific first-line immune response to an infection. The research showed that the reovirus can infect and activate immature human dendritic cells. The reovirus-activated DC triggered anti-tumour cytotoxicity when co-cultured with two other types of immune cells, natural killer cells and autologous T-cells. The researchers concluded that the reovirus may support early innate anti-tumour immunity as well as inducing direct tumour cell death.
The poster will be available today on the Oncolytics website at www.oncolyticsbiotech.com.

About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics’ clinical program includes a variety of Phase I and Phase I/II human trials using REOLYSIN®, its proprietary formulation of the human reovirus, alone and in combination with radiation. For further information about Oncolytics, please visit www.oncolyticsbiotech.com

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the implication of the materials presented at this conference with respect to REOLYSIN®, the Company’s expectations related to the results of trials investigating delivery of REOLYSIN®, and the Company’s belief as to the potential of REOLYSIN® as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements.

FOR FURTHER INFORMATION PLEASE CONTACT:
For Canada:
Oncolytics Biotech Inc.
Cathy Ward
210, 1167 Kensington Cr NW
Calgary, Alberta T2N 1X7
Tel: [phone]
Fax: [phone]
[e-mail]
www.oncolyticsbiotech.com

For Canada:
The Equicom Group
Nick Hurst
20 Toronto Street
Toronto, Ontario M5C 2B8
Tel: [phone] ext. 226
Fax: [phone]
[e-mail]

For United States:
The Investor Relations Group
Damian Mcintosh
11 Stone St, 3rd Floor
New York, NY 10004
Tel: [phone]
Fax: [phone]
[e-mail]

30-


News Release Index

[merx]

Antwort auf Beitrag Nr.: 23.822.296 von merx am 08.09.06 12:52:10

http://www.newswise.com/articles/view/523401/

Gruß

merx