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CELL GENESYS -GVAX - 500 Beiträge pro Seite


CELL GENESYS dürfte nun nach dem erfolg von PROVENGE mit ihrem Vaccin-GVAX nun auch in das Rampenlicht rücken.Phase3 gegen Prostatakrebs
und der Rest der Pipline ist auch nicht ohne.
asics
Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms -- GVAX(TM) cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2 trials of GVAX immunotherapy for pancreatic cancer and leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has its principal manufacturing operation in Hayward, CA. For additional information, please visit the company's website at www.cellgenesys.com.
Antwort auf Beitrag Nr.: 28.602.398 von asics01 am 31.03.07 18:18:38Na wenn da nicht mal was im Buscht ist. Heute war die web cast Konferenz (Lehman Brothers) um 2.30 . Seit dem ist der Kurs in den USA bei recht gutem Volumen nach oben gegangen und hat fast im Tageshoch geschlossen, das lässt Gutes hoffen für morgen. Wenn am Donnerstag das Aproval von der FDA kommt, knallen die Korken. CEGE dürfte dann eine vergleichbare Tagesperformance hinlegen wie Dendreon Corp. (DNDN) die am Freitag von 5 auf 19 USD gestiegen ist. In CEGE besteht derzeit eine short position von über 7 Mio aktien. Die Hedge Fonds werden bei positiven Ausgang am Donnerstag für ein Blutbad sorgen.

Viel Glück
Additional follow-up of the 22 patients who received the dose that is comparable to that being employed in the company's ongoing Phase 3 program indicates that the median survival is 35.0 months.


http://phx.corporate-ir.net/phoenix.zhtml?c=98399&p=irol-new…

...diese Ergebnisse sind sehr viel versprechend. Da darf man auf die ersten Daten der Phase-III-Studien gespannt sein!
Cell Genesys hat immer noch Potenzial bis 10 USD.
Wenn GVAX zugelassen wird ist noch Luft bis 25-30 USD.
Also ist noch einiges drinnen.

Aber schaut euch mal Favrille (FVRL) an:
- Mcap. bei rund 100 Mio. USD
- Buchwert bei ca. 60 USD
- Und v.a. ein Medikament in der Pipeline in Phase 3 dass ähnlich wie GVAX wirkt und auch gute Ergebnisse geliefert hat.
Ganz wichtig ist hier noch zu sagen, dass dieses Medikament gegen Lymphdrüsenkrebs wirkt, also keine Konkurrenz zu Provence oder GVAX darstellt.
Deswegen schätze ich hier das Potenziel noch höher ein.
Mein Kursziel sind hier kurzfristig die 10 und langfristig die 50 USD.

Bin schon in beiden Werten drin.
Antwort auf Beitrag Nr.: 28.729.889 von asics01 am 09.04.07 18:54:58Wieso Übertrieben?

CEGE:


DNDN:


NUVO


SIGA:


Achte auf SIGA auch....;)-hier sind wir in die Entstehungsphase (Ausbruchsphase befindlich)- meiner bescheidener Meinung nach, alle vier Werte sind hot z.Zt

Steigende Grüße,
Whyso:cool:
ziemlich ruhig hier


Cell Genesys Reports GVAX Immunotherapy for Prostate Cancer Induces a Broad, Patient-Specific Antibody Response
SOUTH SAN FRANCISCO, Calif., April 17 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE) today reported immune response data from two previously conducted Phase 2 clinical trials of GVAX immunotherapy for prostate cancer. Evaluation of antibody responses in patients with advanced prostate cancer from these studies shows that the GVAX cell-based immunotherapy induces antibody responses to a broad array of prostate cancer- associated antigens, including some not previously known to be associated with prostate cancer. In addition, the antibody responses to this non patient- specific product were predominantly patient-specific and unique from patient to patient, indicating the potential advantage of a cell-based multi-antigen product such as GVAX to generate the broadest and most relevant immune response. Serological analysis of gene expression (SEREX) technology was also used to identify target antigens involved in response to the immunotherapy. More than 148 proteins to which antibody responses were induced were identified and many of these proteins had not been identified previously as prostate cancer-associated antigens. These findings were presented today by Dr. Thomas Harding and colleagues from Cell Genesys at the annual meeting of the American Association for Clinical Research being held in Los Angeles, CA.

GVAX immunotherapy for prostate cancer is currently being studied both as a single agent and in combination with docetaxel chemotherapy in two Phase 3 clinical trials targeted to enroll approximately 1200 patients with metastatic hormone-refractory prostate cancer (HRPC). This ongoing Phase 3 program is supported by the median survival results from two, independent, multi-center Phase 2 clinical trials. Cell Genesys recently reported final, updated results from its second multi-center Phase 2 trial of GVAX immunotherapy for prostate cancer, which evaluated escalating doses of the immunotherapy in 80 patients with metastatic hormone-refractory prostate cancer (HRPC). Additional follow-up of the 22 patients who received the dose that is comparable to that being employed in the company's ongoing Phase 3 program revealed that their median survival is 35.0 months. Four patients have withdrawn consent to further follow-up and thus were censored in the analysis. The company also has previously reported final median survival results from its first multi-center Phase 2 trial of GVAX immunotherapy for prostate cancer in 34 patients with metastatic HRPC that showed an overall median survival of 26.2 months. The survival results from the two, independent multi-center Phase 2 clinical trials compare favorably to the previously published median survival of 18.9 months for metastatic hormone-refractory prostate cancer patients treated with Taxotere(R) (docetaxel) chemotherapy plus prednisone, the current standard of care for these patients. The company's ongoing Phase 3 program is designed to confirm this potential survival benefit of GVAX immunotherapy for prostate cancer.

"The immune response data reported today provide added support for the concept that a whole-cell immunotherapy, such as GVAX immunotherapy for prostate cancer, is an ideal multi-antigen source that is capable of eliciting an immune response to a broad array of tumor-associated antigens," stated Peter K. Working, Ph.D., senior vice president of Research and Development at Cell Genesys. "That the majority of antibody responses are unique to individual patients is further evidence that the non patient-specific format of GVAX immunotherapies is capable of inducing unique, patient-specific immune responses. Moreover, the fact that many of these antigens have not before been associated with prostate cancer, further suggests that a multivalent antigen immunotherapy like GVAX immunotherapy may provide the best potential for inducing an effective anti-tumor immune response, especially for heterogeneous cancers such as prostate cancer."

Evidence of patient-specific immune responses associated with non patient- specific GVAX immunotherapy products has also been reported in other cancers. In August 2004, the company reported on data published in the Journal of Experimental Medicine from a Phase 1 clinical trial of GVAX immunotherapy for pancreatic cancer that provided evidence that patient-specific immune responses can be generated following treatment with this non patient-specific product. The article described detailed analyses of the immune response to the immunotherapy in three out of 14 patients who were long-term survivors and who also demonstrated strong T cell responses to mesothelin, a tumor- associated protein found in the majority of pancreatic cancers and in the GVAX immunotherapy for pancreatic cancer cells. The specificity of the T cell response to mesothelin was shown to be unique to each responding patient providing further scientific proof-of-concept for the company's GVAX immunotherapy strategy.

GVAX immunotherapy for prostate cancer is comprised of two prostate cancer cell lines that have been modified to secrete GM-CSF (granulocyte-macrophage colony stimulating factor), an immune stimulatory hormone, and irradiated for safety. GVAX cancer immunotherapy for prostate cancer is being developed as a non patient-specific, "off-the-shelf" pharmaceutical product.

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms -- GVAX(TM) cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2 trials of GVAX immunotherapies for pancreatic cancer and for leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has its principal manufacturing operation in Hayward, CA. For additional information, please visit the company's website at www.cellgenesys.com.

Statements made herein about the company, other than statements of historical fact, including statements about the company's progress, results and timing of clinical trials and preclinical programs and the nature of product pipelines are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials and research and development programs, the regulatory approval process for clinical trials, competitive technologies and products, patents, continuation of corporate partnerships and the need for additional financings. For information about these and other risks which may affect Cell Genesys, please see the company's Annual Report on Form 10-K for the year ended December 31, 2006 filed on March 1, 2007 as well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The company assumes no obligation to update the forward-looking information in this press release.

Contact: Ina Cu
Investor Relations
650-266-3200

SOURCE Cell Genesys, Inc.
04/17/2007
/CONTACT: Ina Cu, Investor Relations of Cell Genesys, Inc.,
+1-650-266-3200
/Web site: http://www.cellgenesys.com
(CEGE)

CO: Cell Genesys, Inc.
ST: California
IN: HEA BIO
SU: TRI TDS

HD
-- SFTU061 --
7462 04/17/2007 07:00 EDT http://www.prnewswire.com




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Cell Genesys Completes Patient Recruitment for First Phase 3 Clinical Trial of GVAX Immunotherapy for Prostate Cancer
SOUTH SAN FRANCISCO, Calif., July 10 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE) today announced that it has completed recruitment of over 600 patients into VITAL-1, the first of two ongoing Phase 3 clinical trials of GVAX immunotherapy for prostate cancer.

The multi-center, randomized, controlled Phase 3 study in advanced prostate cancer will compare GVAX cancer immunotherapy to Taxotere(R) (docetaxel) chemotherapy plus prednisone in hormone refractory prostate cancer (HRPC) patients with metastatic disease. The primary endpoint of the trial is an improvement in survival.

"Entering this final stage of patient recruitment for the first of our two Phase 3 clinical trials of GVAX immunotherapy for prostate cancer is an important milestone for the program, and we are very grateful to the men with prostate cancer and their physicians involved in this trial as well as the Cell Genesys employees who have made this possible," stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys. "With the completion of patient recruitment behind us, we can now estimate the timing of the pre-planned interim analysis for the VITAL-1 trial to be in 2008, probably during the first half of the year, and that we will have a sufficient number of events required for the final analysis to follow sometime later in 2009."

Cell Genesys received Fast Track designation from the U.S. Food and Drug Administration for GVAX immunotherapy for prostate cancer and Special Protocol Assessments for VITAL-1 and VITAL-2, the second ongoing Phase 3 study currently under way at approximately 90 sites in the United States, Canada and Europe. VITAL-2 is enrolling metastatic HRPC patients who are symptomatic with cancer-related pain. The study will compare GVAX cancer immunotherapy plus Taxotere chemotherapy to Taxotere plus prednisone. The primary endpoint of the study is an improvement in survival. The company expects to recruit approximately 600 patients into VITAL-2 and plans to update the timeline for the completion of recruitment by the end of 2007.

Cell Genesys' ongoing Phase 3 GVAX immunotherapy for prostate cancer program is supported by the median survival results from two, independent, multi-center Phase 2 clinical trials in approximately 115 patients. The subset of patients in these two trials who received the doses comparable to the Phase 3 dose showed median survival of 34.9 months and 35.0 months, respectively. These results also exceeded the predicted survival of 22.5 months and 22.0 months, respectively, as determined by a seven point patient disease characteristic nomogram. The results of the first trial were published in the July 1 issue of Clinical Cancer Research. Results from both studies compare favorably to the previously published median survival of 18.9 months for metastatic HRPC patients treated with Taxotere chemotherapy plus prednisone, the current standard of care. Moreover, as previously reported, the safety profile observed in Phase 2 trials of GVAX immunotherapy for prostate cancer compares favorably with that reported for chemotherapy. The Phase 3 program is designed to confirm a potential survival benefit and safety profile for GVAX immunotherapy for prostate cancer.

About GVAX Immunotherapy for Prostate Cancer

Cell Genesys' GVAX cancer immunotherapies are whole-cell products that are designed to present the immune system with a broad spectrum of tumor antigens and stimulate an immune response against the patient's tumor. GVAX immunotherapy for prostate cancer is comprised of two prostate tumor cell lines that have been modified to secrete GM-CSF (granulocyte-macrophage colony stimulating factor), an immune stimulatory hormone which plays a key role in stimulating the body's immune response, and then are irradiated for safety. GVAX cancer immunotherapy for prostate cancer is being developed as a non patient-specific, "off-the-shelf" pharmaceutical product. The company is currently manufacturing GVAX immunotherapy for prostate cancer in its bioreactor manufacturing facility in Hayward, California, a facility that is also capable of producing the product during its initial commercialization.

About Cell Genesys

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms - GVAX(TM) cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2 trials of GVAX immunotherapies for pancreatic cancer and for leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has its principal manufacturing operation in Hayward, CA. For additional information, please visit the company's website at www.cellgenesys.com.

Statements in this press release which are not strictly historical are forward-looking statements, including statements about the company's progress, timing and results of clinical trials (such as the analysis for the VITAL-1 trial) and pre-clinical programs, and the nature and prospects of product pipelines. As such, they are subject to significant risks and uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials and research and development programs, the regulatory approval process for clinical trials, competitive technologies and products, patents, continuation of corporate partnerships and the need for additional funding. For information about these and other risks which may affect Cell Genesys, please see the company's Securities and Exchange Commission filings, including Forms 10-K, 10-Q, 8-K, and other SEC filings. Cell Genesys assumes no obligation to update the forward-looking statements in this press release.

Contact:

Susan Ferris
Investor Relations
650-266-3200

SOURCE Cell Genesys, Inc.
07/10/2007
CONTACT: Susan Ferris, Investor Relations of Cell Genesys,
+1-650-266-3200/
Web site: http://www.cellgenesys.com
(CEGE)





About Us | Product Progress | Patient Information | Investor's Corner | Career
Cell Genesys Reports Second Quarter 2007 Results
SOUTH SAN FRANCISCO, Calif., Aug. 7 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE) today reported financial results for the second quarter ended June 30, 2007. The company reported a net loss of $1.9 million, or $0.03 per fully diluted share, for the second quarter of 2007, compared with a net loss of $27.9 million, or $0.60 per fully diluted share, in the corresponding period of 2006.

The decrease in net loss reported in the second quarter of 2007 compared with the net loss for the corresponding period in the previous year is due to a favorable settlement with the Internal Revenue Service (IRS) in the second quarter of 2007 relating to the company's 2000 tax return. The settlement resulted in a decrease of approximately $26.8 million in accrued income tax liabilities following a payment to the IRS of $3.3 million in federal tax and interest.

"We are very pleased with our recent business progress, most notably the completion of patient recruitment in the first of two ongoing Phase 3 trials of our lead product, GVAX immunotherapy for prostate cancer. This is a major milestone for this program and our business in general," stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys. "We are equally pleased that we have been able to maintain our financial strength as we advance this key development program with a successful equity financing during the quarter."

Revenues for the second quarter ended June 30, 2007, were less than $0.1 million compared with revenues of $1.0 million for the corresponding period in 2006. The difference is due to the timing of revenue from existing licensing arrangements which varies from quarter to quarter.

The company's research and development costs were $25.0 million for the second quarter of 2007 compared with $23.2 million for the corresponding period in 2006. The increase is primarily due to expenses related to the ongoing Phase 3 clinical trials of the company's lead product development program, GVAX immunotherapy for prostate cancer. General and administrative expenses were $4.8 million for the second quarter of 2007 compared to $4.3 million for the corresponding period in 2006. This increase is primarily attributed to an increase in administrative expenses.

As of June 30, 2007, Cell Genesys had approximately $171.1 million in cash, cash equivalents and short-term investments compared to $154.1 million at December 31, 2006. The ending second quarter balance reflects gross proceeds raised since the beginning of 2007, including $12.5 million raised in the first quarter from the company's Committed Equity Financing Facilities with Kingsbridge Capital Limited, and $60.0 million raised from a registered direct offering in the second quarter.

Second Quarter and Other Recent Highlights

-- Announced the completion of recruitment of over 600 patients into
VITAL-1, the first of two ongoing Phase 3 clinical trials of GVAX
immunotherapy for prostate cancer. The multi-center, randomized,
controlled Phase 3 study in advanced prostate cancer will compare GVAX
cancer immunotherapy to Taxotere(R) (docetaxel) chemotherapy plus
prednisone in hormone refractory prostate cancer (HRPC) patients with
metastatic disease. The primary endpoint of the trial is an improvement
in survival. The company estimates the timing of the pre-planned
interim analysis from the VITAL-1 trial to be in 2008, probably in the
first half of the year, and that there will be a sufficient number of
events required for the final analysis to follow sometime later in
2009.

-- Reported updated clinical data for GVAX immunotherapy for prostate
cancer from the second of two, independent, multi-center Phase 2
clinical trials, which combined involved approximately 115 patients.
Data from these two trials showed a median survival of 34.9 months and
35.0 months, respectively, for the patients who received doses
comparable to the Phase 3 dose. The results of the first trial were
published in the July 1, 2007, issue of Clinical Cancer Research.
These results exceeded the predicted survival of 22.5 months and 22.0
months, respectively, as determined by a seven point patient disease
characteristic nomogram. Results from both studies also compare
favorably to the previously published median survival of 18.9 months
for metastatic HRPC patients treated with Taxotere chemotherapy plus
prednisone, the current standard of care. The company's ongoing
Phase 3 program is designed to confirm a potential survival benefit and
safety profile for GVAX immunotherapy for prostate cancer.

-- Reported at the American Association for Cancer Research meeting in
April 2007, immune response data from the company's two previously
conducted Phase 2 clinical trials of GVAX immunotherapy for prostate
cancer. Evaluation of antibody responses in patients with advanced
prostate cancer from these studies shows that the GVAX cell-based
immunotherapy induces antibody responses to a broad array of prostate
cancer-associated antigens, including some not previously known to be
associated with prostate cancer. In addition, the antibody responses to
this non patient-specific product were predominantly patient-specific
and unique from patient to patient, indicating the potential advantage
of a cell-based multi-antigen product such as GVAX to generate the
broadest and most relevant immune response.

-- Announced three new clinical trials for GVAX immunotherapy for leukemia
that are now under way in collaboration with the Johns Hopkins Sidney
Kimmel Cancer Center. The new trials are based on encouraging results
in an initial Phase 2 study of the product in patients with chronic
myelogenous leukemia (CML) and include: a randomized Phase 2 trial in
56 patients with CML who have persistent molecular evidence of disease
following Gleevec(R) (imatinib) therapy that will compare the
combination of GVAX plus continued Gleevec to the combination of
interferon-alpha, GM-CSF plus continued Gleevec with respect to the
levels of bcr-abl, a well-established marker of residual leukemia. In
addition, there will be an extension study of the initial Phase 2 trial
in patients with CML that will evaluate the efficacy of a second course
of GVAX in patients who failed to achieve a sustained complete response
and a Phase 1 trial in 18 patients with poor risk myelodysplastic
syndrome.

-- Announced follow-up data from a Phase 2 clinical trial of GVAX
immunotherapy for pancreatic cancer that was conducted by the Johns
Hopkins Sidney Kimmel Cancer Center. The trial enrolled 60 patients
with operable pancreatic cancer who received GVAX after surgical
resection of their tumor and adjuvant radiation and chemotherapy. The
median overall survival for these patients was previously reported to
be 26.8 months, a result which compares favorably to the 17 to
22 months median survival results published from multiple studies in
patients undergoing pancreatic cancer surgery and adjuvant therapy. Of
note, 53 of the 60 patients were considered high risk, based on the
unfavorable finding that their cancer had spread to regional lymph
nodes. The new data included a median disease-free survival of
approximately 16 months which compares favorably to the 13 months
disease-free survival recently reported for gemcitabine adjuvant
therapy.

-- Announced follow-up data from the ongoing Phase 1 clinical trial in
patients with advanced prostate cancer receiving GVAX immunotherapy for
prostate cancer administered in combination with ipilimumab (MDX-010),
a fully human anti-CTLA-4 antibody that is being jointly developed by
Medarex and Bristol-Myers Squibb Company. The new data reported
includes median follow-up of 18 months on the first 12 patients
enrolled in the trial. Of the six patients who have received the two
highest doses, antitumor activity has been observed in five patients,
including prostate-specific antigen (PSA) declines of greater than
50 percent that were maintained in four of these patients for at least
six months, with the longest response to date at approximately
16 months. Clinical evidence of antitumor activity has been observed
in four of these five PSA responders, including complete resolution of
multiple lesions on bone scan in two patients, and resolution of
abdominal lymph node disease by CT scan and improvement in bone pain in
one patient each. The five patients with PSA declines experienced
either Grade 2 or 3 immune-mediated endocrine deficiencies similar in
type to those previously reported with ipilimumab therapy, and were
successfully treated with standard hormone replacement therapy and one
patient who received the highest dose of ipilimumab developed a Grade 3
dose-limiting pulmonary alveolitis that responded to steroid treatment.
Immunomonitoring studies showed that the combination therapy enhanced T
cell and dendritic cell activity, which was more pronounced at the
higher dose levels.

-- Raised gross proceeds of $60.0 million in a registered direct offering
to institutional investors of 10.8 million shares of the company's
common stock at $5.55 per share and warrants to purchase up to
2.2 million shares of the company's common stock at a price of $7.18
per share with selected institutional investors.

-- Reached a favorable settlement with the IRS regarding the audit of the
company's 2000 tax return. The settlement with the IRS was for
$3.3 million in taxes and interest and resulted in a decrease in
accrued income tax liabilities of $26.8 million.


Cell Genesys will host its quarterly conference call at 2:00 p.m. PST on Tuesday, August 7, 2007, to discuss events that occurred during the second quarter of 2007. Investors may listen to the webcast of the conference call live on Cell Genesys' website. Alternatively, investors may listen to a replay of the call by dialing 800-475-6701 from locations in the U.S. and 320-365-3844 from outside the U.S. The call-in replay will be available for at least 72 hours following the call. Please refer to reservation number 880320.

About Cell Genesys

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms -- GVAX(TM) cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2 trials of GVAX immunotherapies for pancreatic cancer and for leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has its principal manufacturing operation in Hayward, CA. For additional information, please visit the company's website at http://www.cellgenesys.com.

Statements made herein about the company, other than statements of historical fact, including statements about the company's progress, results and timing of clinical trials and preclinical programs and the nature of product pipelines are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials and research and development programs, the regulatory approval process for clinical trials, competitive technologies and products, patents, continuation of corporate partnerships and the need for additional financings. For information about these and other risks which may affect Cell Genesys, please see the company's Annual Report on Form 10-K for the year ended December 31, 2006 filed on March 1, 2007 as well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The company assumes no obligation to update the forward-looking information in this press release.

CONTACT:
Susan Ferris
Investor Relations
650-266-3200

-- FINANCIAL CHARTS TO FOLLOW --


SELECTED CONSOLIDATED FINANCIAL INFORMATION

CONSOLIDATED STATEMENTS OF OPERATIONS DATA
(unaudited, in thousands, except per share data)

Three months ended Six months ended
June 30, June 30,
2007 2006 2007 2006

Revenue $3 $1,046 $1,276 $1,222
Operating expenses:
Research and development 25,030 23,203 49,045 48,517
General and administrative 4,782 4,268 10,027 9,296
Total operating expenses 29,812 27,471 59,072 57,813
Loss from operations (29,809) (26,425) (57,796) (56,591)
Other income (expense):
Gain on sale of Abgenix,
Inc. common stock - - - 62,677
Gain on sale of property
and equipment 1,381 9 1,384 9
Interest and other income 2,201 1,756 4,120 3,316
Interest expense (2,582) (2,622) (5,181) (5,244)
Income (loss) before income
taxes (28,809) (27,282) (57,473) 4,167
Income tax benefit (provision) 26,918 (610) 26,133 (28,045)
Net loss $(1,891) $(27,892) $(31,340) $(23,878)

Basic and diluted net loss
per common share $(0.03) $(0.60) $(0.48) $(0.52)
Weighted average shares of
common stock outstanding -
basic and diluted 71,171 46,629 65,939 46,127


CONSOLIDATED BALANCE SHEET DATA
(in thousands) June 30, December 31,
2007 2006
(unaudited) Note 1
Cash, cash equivalents and short-term
investments, including restricted cash $171,079 $154,074
Prepaid expenses and other current assets 3,535 3,481
Property and equipment, net 123,237 129,643
Unamortized debt issuance costs and other assets 3,550 3,969

Total assets $301,401 $291,167

Other current liabilities $16,496 $15,904
Current portion of accrued income taxes - 35,410
Other liabilities 3,150 2,851
Non-current portion of accrued income taxes 5,947 -
Non-current portion of capital lease obligation 47,588 48,475
Convertible senior notes 145,000 145,000
Stockholders' equity 83,220 43,527

Total liabilities and stockholders' equity $301,401 $291,167

Note 1. Derived from audited financial statements.

SOURCE Cell Genesys, Inc.
08/07/2007
CONTACT: Susan Ferris, Investor Relations of Cell Genesys, Inc.,
+1-650-266-3200
Web site: http://www.cellgenesys.com
(CEGE)




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©2006 Cell Genesys, Inc. | Site Design: Heiney & Craig, Inc. | Home | Search
Cell Genesys to Present at the Bear Stearns 20th Annual Healthcare Conference
SOUTH SAN FRANCISCO, Calif., Sept 04, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Cell Genesys, Inc. (Nasdaq: CEGE), today announced that Sharon E. Tetlow, senior vice president and chief financial officer of Cell Genesys, will present a company update at the Bear Stearns 20th Annual Healthcare Conference in New York City on Tuesday, September 11, 2007, at 2:00 p.m. ET.
A live audio webcast of the presentation will be accessible through the Investor Relations section of the Cell Genesys website, http://www.cellgenesys.com. If you are unable to listen to the live webcast, it will be archived on the site for at least 72 hours following the presentation. To access the replay, go to the Investor Relations section of the website.

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms -- GVAX(TM) cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2 trials of GVAX immunotherapies for pancreatic cancer and for leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has its principal manufacturing operation in Hayward, CA. For additional information, please visit the company's website at http://www.cellgenesys.com.

Contact:

Susan Ferris
Investor Relations
650-266-3200


SOURCE Cell Genesys, Inc.

http://www.cellgenesys.com




About Us | Product Progress | Patient Information | Investor's Corner | Career Opportunities
©2006 Cell Genesys, Inc. | Site Design: Heiney & Craig, Inc. | Home | Search | Contact Us
Cell Genesys to Present at the Rodman and Renshaw 9th Annual Healthcare Conference
SOUTH SAN FRANCISCO, Calif., Oct. 30 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE), today announced that Sharon E. Tetlow, senior vice president and chief financial officer of Cell Genesys, will present a company update at the Rodman and Renshaw 9th Annual Healthcare Conference in New York City on Tuesday, November 6, 2007, at 5:05 p.m. ET.

A live audio webcast of the presentation will be accessible through the Investor Relations section of the Cell Genesys website, http://www.cellgenesys.com. If you are unable to listen to the live webcast, it will be archived on the site for at least 72 hours following the presentation. To access the replay, go to the Investor Relations section of the website.

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms -- GVAX(TM) cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2 trials of GVAX immunotherapies for pancreatic cancer and for leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has its principal manufacturing operation in Hayward, CA. For additional information, please visit the company's website at http://www.cellgenesys.com.

Contact:

Susan Ferris
Investor Relations
650-266-3200

SOURCE Cell Genesys, Inc.
10/30/2007
CONTACT: Susan Ferris, Investor Relations of Cell Genesys, Inc.,
+1-650-266-3200
/Web site: http://www.cellgenesys.com
(CEGE)
dendreon und jetzt gpc gescheitert,jetzt wollen wir mal hoffen dass cege mehr erfolg mit GVAX gegen prostatakrebs hat.
Mein Zielkurs "unter 3 USD" ist erreicht und somit melde ich meine erste Positionierung.

Cell Genesys ist eine der Hoffnungen im Bereich Immunisierungstherapie gegen Krebs.

Phase II Ergebnisse von GVAX in HRPC (hormonresistentem Prostatakrebs) waren hervorragende mehr als 12 Monate besser als der Standard of Care: Taxotere. In zwei Phase II Studien in der höchsten Dosierungsgruppe jeweils ca. 35 Monate.

Aktuell werden zwei Phase III Studien durchgeführt, eine 1st line Vergleich gegen Taxotere und die zweite in Kombination mit Taxotere gegen Taxotere alleine. Studie 1 hat Patientenaufnahme schon abgeschlossen, Studie 2 wird dies Ende 2008, Anfang 2009 tun.

Phase I Ergebnisse von GVAX in HRPC in Verbindung mit MEDX-010 (ipilimumab) sind mit 80% Responserate auch sehr ermutigend.

GVAX zeigte zudem Wirkung in Leukämien und Bauchspeicheldrüsenkrebs, womöglich wird die Plattform in allen Krebsarten getestet und eventuell wirksam sein können.

Vergleich zu Dendreon:
Marktkapitalisierung DNDN: 700 Mio USD
Marktkapitalisierung CEGE: 200 Mio USD

Cash DNDN: 135 Mio USD
Cash CEGE: 160 Mio USD

Cashburn ungefähr gleich und Endergebnisse der Studien ungefähr zur selben Zeit erwartet (Endpunkt Overall Survival). Allerdings hat DNDN den Vorteil, bei positiven Interimsdaten schon Zulassung beantragen zu können (Absprache mit FDA).

In der Technologie von CEGE sehe ich zudem Vorteile, es ist keine patientenspezifische teure Behandlung nötig wie bei Provenge, es handelt sich um ein vorgefertigtes Vaccine, daher weit höheres Vermaktungspotential.
[URL]http://www.tradesignalonline.com/content.asp?p=wpa/tsb/default.asp&fcid=2418960[/URL]
[URLChart öffnen]http://www.tradesignalonline.com/content.asp?p=wpa/tsb/default.asp&fcid=2418960[/URL]

Weiterer Nachkauf nach Bodenbildung, sofern der dann mögliche EK mindestens 10% kleiner ist als mein heutiger EK.
Cell Genesys Downgrade


Rating-Update:
New York (aktiencheck.de AG) - Die Analysten von Needham & Co stufen die Aktie von Cell Genesys (ISIN US1509211041/ WKN 888140) von "buy" auf "hold" zurück. (02.11.2007/ac/a/u)
Analyse-Datum: 02.11.2007
rancherho, IV board:

Recs: 6 A Brief Summary of CEGE for Anyone Interested
1. IMO, a great way to understand the science and Method of Action of CEGE’s lead GVAX therapy in Hormone Resistant Prostate Cancer (HRPC) is to watch the video webcast of the presentation of Dr. Kristan Hege at: Bringing Therapeutic Cancer Vaccines and Immunotherapies Through Development to Licensure (Day 1) Thursday, February 08, 2007 Begin at Time: 56 minutes. The first few minutes and slides in her presentation are particularly informative since they explain why just infusing irradiated prostate cancer cells alone, or in combination with recombinant GM-CSF doesn’t work (see the 21 day murine slides) while irradiated cancer cell lines expressing GM-CSF recruit and prime CD11c marked dendritic cells. The GVAX method of activating dendritic cells in vivo is somewhat akin to the fusion protein “cassette technology” linking a target antigen to GM-CSF, which DNDN uses to mature dendritic cells ex vivo. http://videocast.nih.gov/PastEvents.asp?c=1&s=21

2. The agenda for all the FDA / NCI Workshop presentations is at: https://cms.palladianpartners.com/cms/1156354418/materials/f…


3. Since then, a report on Phase 2 has been published in Clinical Cancer Research at: http://clincancerres.aacrjournals.org/cgi/content/abstract/1… CEGE has reported since then in September that in Ph2 trials, the high dose GVAX patients taking chemotherapy after GVAX (9 of 13 docetaxel) who had median survival >35.2 months in 4/07 had still not reached median survival.

4. As Rr. Hege described, GVAX in AIPC is an allogenic cancer vaccine that uses two prostate cancer cell lines, genetically engineered to express GM-CSF and irradiated so that they cannot proliferate when infused into patients. The 600 patient Vital-1 Phase 3 trial with the endpoint of survival in asymptomatic AIPC/HRPC began enrollment in July 2004 and was been fully enrolled as of July. It compares GVAX to Taxotere, the standard of care. GVAX patients may subsequently take Taxotere, but must then discontinue further GVAX. Taxotere control patients can not, however, take GVAX.TheVital-1 interim look that is triggered by a pre-specified number of deaths is expected in 1H08, with the final look sometime in 2009. CEGE has a FDA Special Protocol Assessment (SPA) that will allow them to file a BLA if Vital 1 hits its statistical targets at either the interim or final look. The asymptomatic subgroup in the Taxotere TAX327 Ph3 pivotal trial had a median survival time of 23 months. The median survival of the Ph2 GVAX patients in the two trials taking the same high dose as is being used in all Ph3 trials was 34.9 and 35.0 months.

5. The 600 patient Vital-2 trial in symptomatic AIPC/HRPC with the endpoint of survival began enrollment in July 2005. It compares GVAX plus Taxotere to GVAX alone. CEGE announced in a recent CC that it expects the interim look in early 2009 about the same time that it anticipates full enrollment. The symptomatic subgroup in the Taxotere TAX 327 Ph3 trial had a median survival of 16 months. This suggests that the trial is about half enrolled now. CEGE has stated that this trial has also has a SPA which will allow filing a BLA if statistical targets are met.

6. Dosing in Vital 1 and Vital 2 is as follows:

Patients in Vital-1 can take Chemo after 24 weeks of GVAX treatments, but once they start a non-GVAX procedure they will not be allowed to return to GVAX.

Vital-1 trial:
ARM 1: Initial cancer immunotherapy treatment is 13 bi-weekly injections over 24 weeks, followed by monthly cancer immunotherapy injections for life or until a new treatment for prostate cancer begins.

ARM 2: Taxotere administered every 21 days and prednisone daily for 9 cycles.

Vital-2 trial:
Arm 1: Cancer immunotherapy injections in combination with Taxotere every 21 days over 10 cycles followed by monthly cancer immunotherapy injections alone for life or until a new treatment for prostate cancer begins.

Arm 2: Taxotere administered every 21 days and prednisone daily for 10 cycles.

7. John Hopkins is enrolling a Ph2 trial in HER2/neu breast cancer (open video) in combination with Herceptin” http://wjz.com/local/breast.cancer.vaccine.2.568678.html
http://www.clinicaltrials.gov/ct2/show/NCT00399529?term=brea…

8. Pancreatic Cancer: Phase 2 data; booster GVAX recommended in for further study. http://media.corporate-ir.net/media_files/IROL/98/98399/2007…

9. Leukemia: Ph1 data given when Gleevec begins to fail: http://media.corporate-ir.net/media_files/IROL/98/98399/ASCO…

10. CEGE also announced that they expect to report further in 2008 on their oncolytic virus program in bladder cancer as well as further updates on their early trial combining GVAX in AIPC with MDX-010 at CTLA blocker. http://media.corporate-ir.net/media_files/IROL/98/98399/2007…

11. Recent webcasts: http://phx.corporate-ir.net/phoenix.zhtml?c=98399&p=irol-web…

12. Infrastructure: The CEGE CEO, Dr. Sherwin, also reported in a recent CC that CEGE built a cGMP GVAX production facility sufficient to launch commercial production at a cost of “north of $50 million. Although the facility will not be inspected by the FDA on a FDA preapproval cGMP inspection, the State of California inspects the facility every year.

IMO, CEGE's GVAX for AIPC and DNDN's Provenge, the efficacy of each significantly enhanced when used in combination with Taxotere, will become the first cellular cancer immunotherapies / vaccines that the FDA will approve. Given preparation of BLAs and FDA review cycles, this will probably occur during 2009. Their use in combination might also become commonplace one day. All JMHO.
Interim Analysis Supports Continuation of Cell Genesys' VITAL-1 Phase 3 Clinical Trial of GVAX Immunotherapy for Prostate Cancer
Conference Call Scheduled for 10:00 a.m. ET Today
SOUTH SAN FRANCISCO, Calif., Jan 14, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Cell Genesys, Inc. (Nasdaq: CEGE) today announced that the Independent Data Monitoring Committee (IDMC) for VITAL-1, the first of two ongoing Phase 3 clinical trials of GVAX immunotherapy for prostate cancer, has completed a pre-planned interim analysis and has recommended that the study continue. This event-driven interim analysis was designed to determine whether the study should continue to completion and took place in the time frame originally estimated. As is customary to preserve study blinding, the IDMC provided no information to the company other than the recommendation to continue the trial.
"The IDMC's recommendation to continue with the VITAL-1 trial represents an important step forward in the Phase 3 development of GVAX immunotherapy for prostate cancer and in our effort to make this product available as a new treatment option for men with prostate cancer," stated Robert Dow, MBChB, chief medical officer of Cell Genesys. "Moreover, we can currently estimate that we will reach the required number of events needed to conduct the final analysis in the second half of 2009."

VITAL-1 is a multi-center, randomized, controlled Phase 3 clinical trial designed to compare GVAX cancer immunotherapy to Taxotere(R) (docetaxel) chemotherapy plus prednisone in hormone refractory prostate cancer (HRPC) patients with metastatic disease who are asymptomatic with respect to cancer- related pain. The primary endpoint of the trial is an improvement in survival. VITAL-1 was initiated in July 2004 and completed recruitment of 626 patients in July 2007. Patients were enrolled at approximately 130 sites in North America and Europe.

The company's second Phase 3 trial, VITAL-2, is a multi-center, randomized, controlled Phase 3 clinical trial designed to evaluate the safety and efficacy of GVAX immunotherapy for prostate cancer used in combination with Taxotere chemotherapy compared to the use of Taxotere chemotherapy and prednisone in HRPC patients with metastatic disease who are symptomatic with cancer-related pain. The primary endpoint of the trial is also an improvement in survival. VITAL-2 was initiated in June 2005 and is currently enrolling patients at approximately 90 sites in North America and Europe. The company expects to complete enrollment of approximately 600 patients in the first half of 2009 and if this is achieved, to have a sufficient number of events for a pre-planned interim analysis at that time.

The U.S. Food and Drug Administration (FDA) granted Cell Genesys Special Protocol Assessments (SPAs) for both VITAL-1 and VITAL-2. The SPA is a process that allows for official FDA evaluation of a Phase 3 clinical trial and provides trial sponsors with a binding written agreement that the design and analysis of the study are adequate to support a license application submission if that study is performed according to the SPA. Cell Genesys completed the modifications requested by FDA during the review process.

About GVAX Cancer Immunotherapies

GVAX cancer immunotherapies are non patient-specific investigational therapeutics comprised of whole tumor cells that have been modified to secrete GM-CSF (granulocyte-macrophage colony stimulating factor), an immune stimulatory hormone, and then irradiated for safety. GVAX is designed to be administered through intradermal injections on an outpatient basis. To date, over 600 patients have been treated with GVAX cancer immunotherapies in Phase 1 and Phase 2 clinical trials for multiple indications, including prostate cancer, pancreatic cancer, and leukemia. The company is currently manufacturing GVAX immunotherapy for prostate cancer in its bioreactor manufacturing plant in Hayward, California, a facility that is also capable of manufacturing the product during commercialization.

Conference Call and Webcast

Members of the Cell Genesys management team will host a conference call today, Monday, January 14 at 10:00 a.m. ET to discuss today's announcement. Investors may listen to the webcast of the conference call live on the investor section of the Cell Genesys website, http://www.cellgenesys.com. Alternatively, investors may listen to a replay of the call by dialing 800-475-6701 from locations in the United States and 320-365-3844 from outside the United States. The call-in replay and webcast will be available for at least 72 hours following the call. Please refer to reservation number 907247.

About Cell Genesys

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms -- GVAX(TM) cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2 trials of GVAX immunotherapies for pancreatic cancer and for leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has its principal manufacturing operation in Hayward, CA. For additional information, please visit the company's website at http://www.cellgenesys.com.

Statements made herein about the company, other than statements of historical fact, including statements about the company's progress, results, analysis, and timing of VITAL-1 and VITAL-2 and other clinical trials and preclinical programs and the nature of product pipelines are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials and research and development programs, regulatory requirements and the regulatory approval process for clinical trials, manufacture and commercialization of the company's products, competitive technologies and products, patents, the need for and reliance on partnerships with third parties, and the need for additional financings. For information about these and other risks which may affect Cell Genesys, please see the company's reports on Form 10-Q, 10-K, and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The company assumes no obligation to update the forward-looking information in this press release.

Susan Ferris
Investor Relations
650-266-3200



SOURCE Cell Genesys, Inc.

http://www.cellgenesys.com
Those who believe investing is simply a matter of evaluating the bottom line have obviously not examined the fundamentals of too many biotech corporations. Many emerging biotech firms are years away from actual production, and have horrific balance sheets. That does not mean potential investors should shy away from them altogether, but they really need to understand the story and how likely it is that the company will deliver the goods.



Just like panning for gold or drilling for oil, what these companies do offer is hope. In the case of Cell Genesys (CEGE) it is the hope for a cure to prostate cancer, the second-deadliest form of cancer among men.

While CEGE focuses on a variety of different cancers and treatment options, it is the company's GVAX immunotherapy for prostate cancer that is invoking memories of Louis Pasteur.

GVAX immunotherapy for prostate cancer is, in essence, a vaccine designed to enlist the body's own immune system to ward off unhealthy, or cancerous, cells. And clinical trials seem to suggest that GVAX has at least landed some early punches in the fight.

In a recent Phase-II trial consisting of 80 Hormone Refractory Prostate Cancer [HRPC] patients, the survival time for the 22 who were administered the highest GVAX dosage is expected to exceed 29.1 months — significantly better than the 19.3 months achieved by Taxotere® (currently the best option for treating HRPC) in a similar, albeit larger, trial.

In fact, Cell Genesys is so optimistic about GVAX as a remedy for prostate cancer that the company asked for and was granted Fast Track status by the FDA in May of 2006. A Fast Track designation helps to expedite the review process and Biologics License Applications (BLAs) for potential life-saving drugs and procedures.

Cell Genesys is currently conducting two Phase-III trials of GVAX immunotherapy for prostate cancer.

The first (VITAL-1) began in July 2004 and compares GVAX to Taxotere® chemotherapy administered with prednisone (an immunosuppressant), while the second (VITAL-2) commenced in June 2005 and compares GVAX plus Taxotere® to Taxotere® plus prednisone.

If those trials go well, all that red ink may turn black — and lives could be saved or prolonged in the process.

Not such a bad investment, perhaps.

irgendwann werden sich hier hoffentlich die shorties die finger gewaltig verbrennen.
ansichten IV board, rancherho:

Parsing CEGE's Vital 1 Interim Results

From a comment and response on the Yahoo MB: >>2. The date for the final endpoint was not updated after the interim - it is still the guess from 2004!<<
I don't think that is accurate. Sherwin spoke of delayed efficacy for the GVAX immunotherapy arm. Based on the Taxotere after Provenge immunotherapy data and the fact that Vital 1 allows Taxotere use in the GVAX arm, which also stops GVAX boosters (unfortunately IMO), the chances are that, as with Provenge, high dose GVAX alone might be able to show a median survival in the same range as the 2.4 month increase in median survival that Taxotere demonstrated in its pivotal TAX 327 clinical trial, but bettering it by 33% or more, even with high dosing, would be extraordinary. OTOH, IMO, there is a real possibility that the increase in median survival for experimental arm patients taking Taxotere after high dose GVAX could exceed the overall 35 months that high dose GVAX Ph2 patients demonstrated, since a maximum of 9 of 34 of those Ph2 patients took a subsequent taxane. It is also interesting to note that two of the lead GVAX investigators who coauthored the Ph2 studies, Drs. Small and Higano, were also lead investigators for the Provenge Ph2 studies and are well aware of the critical importance of subsequent Taxotere.

So where does that leave the GVAX Vital 1 interim? One possible assumption might be that the median survival of the Taxotere control arm and the experimental patients who did not subsequently crossover to Taxotere were approximately equal. If the Taxotere control arm event rate was significantly greater than the experimental GVAX arm event rate, Vital 1 would have been stopped on safety and ethical grounds. If the treatment effect of the combination therapy is significantly greater than either GVAX or Taxotere alone, it is likely that the event rate for that subgroup in the experimental arm would begin a rapid decline in comparison to both the Taxotere control arm and the GVAX only subgroup in the experimental arm. Overall, the survival curves for the composite GVAX experimental arm (GVAX alone and GVAX + Taxotere) would flatten out its downward slope relative to the Taxotere (only) control arm. How would GVAX know this? My guess is that the significance of Dr. Petrylak’s November 2006 analysis of the importance of Taxotere after Provenge, which would be quite familiar to Drs. Small and Higano, and was supported by data from the small number of Ph 2 GVAX high dose patients subsequently receiving Taxotere, and the Vital 1 protocol allowing subsequent Taxotere in the GVAX experimental arm, was brought to the attention of all GVAX Vital 1 clinical investigators due to its potential significance for patient care and possible ethical implications. However, the IDMB would watch such a permissive operating hypothesis closely to assure that the safety and efficacy of any use of the GVAX plus Taxotere combination therapy was not trending in the wrong direction. CEGE would see any requirement for booster GVAX fall-off since the protocol requires that to start Taxotere, but that could also be a function of a patient’s choice or death. However, I believe that the IDMB could inform all Vital 1 clinical investigators and CEGE, without revealing any statistical information or breaking data blinding, that combination GVAX + Taxotere subgroup data suggested that it was not harmful to patients and could be beneficial. As the percentage of experimental arm patients taking the combination therapy increases, the experimental arm composite event rate would decline, explaining why it will take at least 2 years from the 7/07 completion of Vital 1 enrollment and 18 months after the assumed 200 event interim for 200 additional events to occur among the remaining 426 enrollees. Overall, this would explain why Sherwin said he was encouraged by the interim, even though he did not receive any statistical data.

Finally the use of the Fleming O’Brien method of allocating an alpha (p value) at an interim point, which Sherwin indicated is what was used, is apparently one of the most conservative methods (suggesting, perhaps a p value =<.005). The delayed response of GVAX plus Taxotere would make this now seem sensible (although it would have been pre-specified before enrollment began in July 2004 and the synergistic effect would have been known.) For the sake of AIPC patients, I hope that DNDN’s Provenge, which will likely have a higher allocated p value at its interim, has positive enough interim data to re-file its BLA when it matures, which they project will occur in mid 2H08. If not, CEGE’s GVAX will likely become the first therapeutic cancer vaccine to receive FDA approval. All JMHO.


http://www1.investorvillage.com/smbd.asp?mb=247&mn=257&pt=ms…
na du stellst mir fragen, da ich weiterhin bei dndn investiert bin und auch bleibe, ist cege einer der am weitesten fortgeschrittesten konkurrenten.

ich denke es wird für beide werte schwer.
die fda würde hier einen schritt machen der intern (scheinbar) auf hartnäckigen widerstand stößt. ich lasse bewußt daten und ergebnisse außen vor.
schau dir die vorgehensweise beim anbau von gen manipuliertem mais in D an, ich persönlich ziehe hier den idiologischen vergleich.

werde aber ein scharfes auge auf cege haben!

alles nur meine persönliche meinung. ;)
Antwort auf Beitrag Nr.: 33.221.434 von GuHu1 am 31.01.08 00:10:05ich wollte doch nur einen tipp von dir.die zwischenergebnisse von GVAX sind bisher top, wenn die ergebnisse der dritten phase (die irgendwann dieses jahr kommen sollen), genauso gut sind wo soll dann das problem der FDA sein???ein zweites PROVEVNGE seitens der FDA wird es sicher nicht mehr geben.
vielleicht ist GVAX besser als PROVENGE, oder andersrum oder alle beide nichts oder was weiß ich:confused::confused::confused:
Antwort auf Beitrag Nr.: 33.222.299 von asics01 am 31.01.08 08:54:30Hi asics,
ich hoffe du hast mein posting nicht falsch verstanden, wollte dich nicht angreifen oder so.
wollte damit nur sagen, dass ich die chance für cege`s GVAX nicht höher einschätze wie bei dndn`s provenge.
ob GVAX besser arbeitet als Provenge, wer weiß, hatten viele auch bei gpc´s satra angenommen.
wie schief man liegen kann zeigt uns das beispiel von GPC.
aus dem grund bin ich mit derlei aussagen auch extrem vorsichtig.

so blöd wie es klingt, dndn könnte eine art wegbereiter für cege werden, \"könnte\".
fallen die interimsdaten zu provenge negativ aus bzw. die beendigung d. laufenden studie 9902b wird voraussetzung für eine provenge zulassung, dann neige ich zur ansicht des IV user rancherho.

....I hope that DNDN’s Provenge, which will likely have a higher allocated p value at its interim, has positive enough interim data to re-file its BLA when it matures, which they project will occur in mid 2H08. If not, CEGE’s GVAX will likely become the first therapeutic cancer vaccine to receive FDA approval.

ich wills nicht beschreien aber ( ipilimumab: MDX-010 ) ist bei metastatic melanoma (monotherapie) an den primären endpunkten gescheitert. :rolleyes:

wenn mich nicht alles täuscht ist MDX-010 auch grundlage bei cege`s GVAX.
gleich im nachgang, schon klar das das ein anderes paar schuhe ist, es geht mir dabei um die tendenz!

trotz dem bin ich auch am überlegen event. die erste kleinere position aufzubauen.

grüße guhu ;)
http://www.medmix.at/set1.php?open=/artikel/515content.php

Provenge®:
Die therapeutische Prostatakrebsvakzine ist in den letzten Zügen der klinischen Entwicklung, dessen wichtigster Bestandteil das Prostata-spezifische Antigen (PSA) ist. Der Impfstoff könnte vor allem auch in früheren Stadien der Erkrankung zum Einsatz zu kommen.
Die individualisierte Provenge®-Therapie besteht aus gentechnisch hergestelltem PSA und patienteneigenen Immunzellen: Dabei werden dendritische Zellen aus dem Blut des Patienten isoliert und nach ihrer Kopplung mit rekombinantem PSA zurück in den Patienten transferiert. Die so aktivierten dendritischen Zellen aktivieren ihrerseits T-Zellen, welche die Tumorzellen, die das Antigen tragen, attackieren und zerstören sollen.
Nach Gabe von Provenge® konnte entweder ein Absinken der PSA-Konzentration oder aber die Verkleinerung des Tumors beobachtet werden. Der Überlebenszeitraum, der mit Provenge behandelten Patienten, konnte mehr als verdoppelt werden.

GVAX®-Technologie:
Die GVAX®-Technologie wird derzeit beim Prostatakarzinom, dem Lungenkarzinom, dem Pankreaskarzinom sowie bei Krebserkrankungen des Blutes – wie etwa der Leukämie und den Myelomen – untersucht. Die Daten einer Phase I/II-Studie bei Lungenkrebs wurden heuer in der renommierten Fachzeitschrift »Journal of the National Cancer Institute« vorgestellt und erörtert. Weiters laufen Phase-II-Studien beim broncho-alveolarem Karzinom, einem Subtyp des nicht-kleinzelligen Lungenkarzinoms und beim Pankreaskarzinom. Die Wirkung von GVAX® beim Prostatakarzinom in Kombination mit Chemotherapie wird demnächst in einer Phase-III-Studie untersucht.
GVAX® unterscheidet sich von den meisten therapeutischen Vakzinen dadurch, dass es – mit Ausnahme gegen das Lungenkarzinom – nicht-patientenspezifisch ist. Die unspezifischen GVAX®-Impfstoffe bestehen aus bestrahlten und genetisch modifizierten Krebszellen, die durch die genetischen Modifikationen dazu in der Lage sind, GM-CSF (Granulozyten-Makrophagen stimulierender Faktor) herzustellen. Die Technologie zielt auf einen universellen Ansatz, da GM-CSF ein Hormon ist, das die körpereigne Immunabwehr ganz generell ankurbelt. Unspezifische Impfstoffe haben gegenüber den individualisierten Produkten den Vorteil, dass sie sich leicht in Massenproduktion herstellen lassen. Obwohl die Tumorzellen in GVAX® nicht vom jeweiligen Patienten stammen, konnte die Impfung bei allen bisher getesteten Krebsarten eine Aktivität des Immunsystems hervorrufen.

http://www.ukaachen.de/go/show?ID=5381454&ALTNAVID=5113065&D…

http://seekingalpha.com/article/34661-cell-genesys-the-promi…

http://www.ft.com/cms/s/2/e4e6a040-4f8f-11dc-b485-0000779fd2…
good post on cege

http://www1.investorvillage.com/smbd.asp?mb=247&mn=249&pt=ms…


Horne, who turns 74 on Wednesday, remains vibrant and healthy-looking. She travels between homes in New York and California, teaching at Carnegie Hall and various colleges and running a summer school and festival in Santa Barbara, Calif.

The week before her birthday, Horne was at Baltimore's Johns Hopkins Sidney Kimmel Cancer Center, getting another dose of a new cancer vaccine that has so far been administered to only about 200 people.

Horne began receiving the injections of lab-grown pancreatic cancer cells in early 2007, after surgery to remove the tumor. The vaccine has been genetically modified with an immune-boosting gene to tackle any lingering malignant cells.

She was injected every two months for a half year, and is now scheduled to get additional doses twice a year.

"Essentially, the vaccine teaches the immune system to recognize those pancreas cancer cells as being foreign and attack them specifically," says Dr. Daniel Laheru, a Johns Hopkins oncologist leading the study. "Her most important treatment was the surgery, but we hope the vaccine is additional insurance against recurrence."
quele IV: :rolleyes:

Recs: 0 Insiders
DNDN - % of Shares Held by All Insider and 5% Owners: 2%
CEGE - % of Shares Held by All Insider and 5% Owners: 10%
GNVC - % of Shares Held by All Insider and 5% Owners: 16%

http://finance.yahoo.com/q/mh?s=DNDN
http://finance.yahoo.com/q/mh?s=cege
http://finance.yahoo.com/q/mh?s=gnvc

I find this disturbing. All that optimism about Provenge and only 2% of shares held by insiders. The executives from other competing companies seems to have more confidence in the outcome of theirs PC clinical trials. Would anybody who is knowledgeable in the subject have a comment or an explanation for this?
Thanks
ist schon eigentümlich der zusammenhang cege zu dndn.

http://www.forbes.com/2008/02/14/dendreon-prostrate-cancer-m…

...........Pantginis believes the competition from Cell Genesys (nasdaq: CEGE - news - people )’ GVAX prostrate cancer vaccine will not allow Dendreon to get a sizable market share. If both drugs get approved, Pantginis says that GVAX will win out because of logistics, cost, and efficacy. Cell Genesys’ shares jumped 4.8%, or 9 cents, to $1.98 in afternoon trading on Thursday.

das IF würde ich erst mal fett unterstreichen (gilt für beide).
Antwort auf Beitrag Nr.: 33.386.344 von Larry_1 am 15.02.08 20:52:59FinanzNachrichten.de, 15.02.2008 14:34:00
Cell Genesys Reports Association Between Immune Response and Patient Survival in Phase 2 Trial of GVAX Immunotherapy for Prostate Cancer
SOUTH SAN FRANCISCO, Calif., Feb. 15 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. today reports the results of an analysis examining the potential association between immune responses to GVAX immunotherapy for prostate cancer and increased patient survival in a Phase 2 trial in patients with metastatic, hormone refractory prostate cancer (HRPC). More than 400 patient-specific GVAX-induced antibody responses were identified in the sera of the treated patients by three different biochemical techniques confirming, as previously reported, that GVAX treatment results in a broad, multi-antigen immune response. An ongoing analysis of these GVAX-induced antibody responses has shown that at least two of the antibody responses are associated with patient survival, an association that is independent of the dose and number of treatments administered. These data will be presented today by Dr. Thomas Harding and colleagues from Cell Genesys at the American Society of Clinical Oncology's Genitourinary Cancer Symposium being held in San Francisco, California.

Cell Genesys has previously reported the results of two multicenter Phase 2 trials of GVAX immunotherapy for prostate cancer in metastatic HRPC. The second of these two trials enrolled 80 patients. The serum of 65 patients (the total number for whom adequate sera were available) were examined to determine each patient's immune response to two specific antigens, HLA-A24 and FLJ14668, following GVAX treatment. Thirty-four of 65 patients demonstrated an FLJ14668-specific antibody immune response. These 34 patients had a median survival of 43 months, compared to a median survival of 21 months achieved by the patients who did not generate anti-FLJ14668 antibodies (p=0.002). Twenty-two of these 65 patients received a dose of GVAX immunotherapy for prostate cancer comparable to that being evaluated in ongoing Phase 3 clinical trials. Of these 22 patients, 16 patients (73 percent) mounted an immune response to FLJ14668. These 16 patients achieved a median survival of 44.9 months. As previously reported, the median survival for all 22 patients in this treatment group was 35.0 months. Finally, of the 58 patients who were HLA-A24 genotype negative and therefore potentially able to mount anti-HLA-A24 specific antibody responses, 30 patients were found to be anti-HLA-A24 antibody positive. These 30 patients had a median survival of 43 months, compared to a median survival of 18 months in the patients who did not generate anti-HLA-A24 antibodies (p=0.05). Importantly, the apparent associations between the presence of these two specific antibody responses and survival were shown by multivariate analysis to be independent of both dose and duration of treatment.

"The findings being reported today indicate a potential association between two specific GVAX-induced antibody responses and patient survival, an association consistent with the proposed mechanism of action for this product. We look forward to expanding these findings in a prospective analysis of the sera of patients treated in our two randomized controlled Phase 3 trials," stated Peter K. Working, Ph.D., senior vice president of research and development at Cell Genesys. "Since GVAX immunotherapy for prostate cancer is a multi-antigen product that can induce a broad immune response, we believe we have a unique opportunity to identify the widest possible array of specific antibody responses that may be associated with clinical benefit."

Cell Genesys is currently evaluating GVAX immunotherapy for prostate cancer in two Phase 3 multicenter, randomized, controlled clinical trials. VITAL-1, which is fully enrolled with 626 patients, is designed to compare GVAX cancer immunotherapy to Taxotere(R) (docetaxel) chemotherapy plus prednisone in HRPC patients with metastatic disease who are asymptomatic with respect to cancer-related pain. The primary endpoint of the trial is an improvement in survival. An interim analysis of the trial was recently conducted by an independent data monitoring committee in the timeframe originally estimated and resulted in the recommendation to continue the trial. The company expects to have enough events to trigger the final analysis of VITAL-1 in the second half of 2009. VITAL-2, which the company expects to fully enroll with approximately 600 patients in the first half of 2009, is designed to evaluate the safety and efficacy of GVAX immunotherapy for prostate cancer used in combination with Taxotere chemotherapy compared to the use of Taxotere chemotherapy and prednisone in HRPC patients with metastatic disease who are symptomatic with cancer-related pain. The primary endpoint of the trial is also an improvement in survival. The company expects to have enough events to trigger an interim analysis of VITAL-2 in the first half of 2009.
Cell Genesys Say's GVAX Increases Patience Survival [CEGE]

2/15/2008 3:20:23 PM Friday, Cell Genesys, Inc. (CEGE), a biotechnology company, said that a phase 2 trial conducted on patients with metastatic, hormone refractory prostate cancer or HRPC identified that GVAX-induced antibody responses are associated with patient survival. The response was indicated as independent of the dose and number of treatments administered.

GVAX cancer immunotherapies are non patient-specific investigational products for fighting prostrate cancer, pancreatic cancer, and leukemia.

The South San Francisco, California-based Cell Genesys said that the more than 400 patient-specific GVAX-induced antibody responses identified in the sera of the treated patients, indicated GVAX treatments to have resulted in broad, multi-antigen immune response. An analysis showed at least two of the antibody responses as associated with patient survival.

Cell Genesys has previously reported the results of two multicenter Phase 2 trials of GVAX immunotherapy for prostate cancer in metastatic HRPC. The second of these two trials enrolled 80 patients.

Depending on the availability of the serum, the company noted that the trial examined 65 patient's immune response to two specific antigens HLA-A24 and FLJ14668, following GVAX treatment. Finally, 30 patients were found to be anti-HLA-A24 antibody positive, with a median survival of 43 months, compared to a median survival of 18 months in patients who did not generate anti-HLA-A24 antibodies.

Twenty-two patients who received a dose of GVAX immunotherapy for prostate cancer comparable to that being evaluated in ongoing Phase 3 clinical trials. Of these, 16 patients achieved a median survival of 44.9 months.

Further, the company noted that it is looking forward to expand these findings in a prospective analysis of the sera of patients treated in two randomized controlled Phase 3 trials.

Cell Genesys is currently evaluating GVAX immunotherapy for prostate cancer in two Phase 3 multicenter, randomized, controlled clinical trials. VITAL-1, which is fully enrolled with 626 patients, is designed to compare GVAX cancer immunotherapy to Taxotere chemotherapy plus prednisone in HRPC patients with metastatic disease who are asymptomatic with respect to cancer-related pain. The primary endpoint of the trial is an improvement in survival. The company expects the final analysis of VITAL-1 in the second half of 2009.

Also VITAL-2, which the company expects to have an interim analysis in the first half of 2009, also has improvement in survival as the primary endpoint.

CEGE is currently trading at $2.4301, up $0.4601 or 23.36% on a volume of 4.16 million shares.
Wer beschätigt sich schon länger mit Cell Genesys, und kann

interpretieren was diese Meldung für CEGE bedeutet, ich meine das

evtl. Umsatzpotiental von GVAX wenn denn die Phase 3 erfolgreich

beendet werden sollte.
Antwort auf Beitrag Nr.: 33.393.776 von GuHu1 am 17.02.08 01:10:59so, ich habe mich vorhin mal von meinem kompletten Bestand getrennt.
Ich denke, das der Kurs wieder etwas runterkommt, dann werde ich wieder ordern
so long
:cool:
Antwort auf Beitrag Nr.: 33.394.637 von Uptick08 am 17.02.08 12:22:42
Feb. 19, 2008, 12:43PM
Cell Genesys Shares Continue Climb

© 2008 The Associated Press

NEW YORK — Shares of Cell Genesys Inc. continued climbing Tuesday, following last week's report showing its vaccine candidate helped prostate cancer patients live longer in a midstage study.

The stock rose 48 cents, or 22 percent, to $2.88 in afternoon trading. On Friday, shares gained 19.7 percent after midstage study results were announced.

"We continue to believe that Cell Genesys is undervalued and has not benefited from the continuous and striking positive clinical data flow to date," said Canaccord Adams analyst Joseph Pantginis, who reaffirmed a "Buy" rating with a $7.70 price target.

On Friday, the company said its GVAX vaccine both invoked an immune response and extended the survival rate of those patients to 43 months, on average. Patients who didn't have an immune response lived for an average of 21 months.

The Food and Drug Administration has yet to approve a cancer vaccine.

Pantginis said the company seems to have accomplished a key goal of simulating the immune system to fight tumors. Also, the drug would likely beat out its competitor Provenge, being developed by Dendreon Corp., based on cost and effectiveness issues.

"Regarding last week's immunological data from both companies, we believe Cell Genesys knocked it out of the park, showing a distinct correlation between specific antigens and survival," he said.

Dendreon reported data showing a general immune response, he said. So far, study subjects taking Provenge have shown a median survival rate of 25.2 months while those taking GVAX have shown a 35 month survival rate, he noted.

He also said that if current late-stage study data on Provenge, set for release in the second half of 2008, turns out to be negative, the company may not be able to recover. Meanwhile, Cell Genesys already has the manufacturing capacity in place for GVAX, while Dendreon has been struggling.

Shares of Dendreon fell 16 cents, or 2.8 percent, to $5.70.
quelle IV:

http://www.investorvillage.com/smbd.asp?mb=971&mn=190494&pt=…

enesys, Inc. ("Cell Genesys") (CEGE) and Takeda Pharmaceutical Company Limited ("Takeda") (TOKYO:4502) today announced that the companies have formed a global alliance for the development and commercialization of GVAX immunotherapy for prostate cancer, Cell Genesys' lead product candidate currently in Phase 3 clinical development.
Under the agreement, in exchange for exclusive worldwide commercial rights to GVAX immunotherapy for prostate cancer, Takeda will pay Cell Genesys an upfront payment of $50 million and additional milestone payments totaling up to $270 million relating to regulatory approval and commercialization of GVAX immunotherapy for prostate cancer in the United States, European Union and Japan. Takeda will pay Cell Genesys tiered, double-digit royalties based on net sales of GVAX immunotherapy for prostate cancer in the United States and flat double-digit royalties based on net sales of the product in all other regions. From this point forward, Takeda will pay for all external development costs associated with the ongoing Phase 3 clinical development of GVAX immunotherapy for prostate cancer and will also pay for all additional development costs and all commercialization costs. Cell Genesys will maintain responsibility for the worldwide manufacture and supply of the product and will retain rights to co-promote GVAX immunotherapy for prostate cancer in the United States.
Heute abend 22Uhr wird es spannend für MEDX und CEGE Aktionäre. Was gibt es neues zu GVAX+ipilimumab(MDX-010) beim AACR? Der Abstract wurde zurückgehalten um die Meldung in das AACR Presseprogramm mitaufzunehmen. Daher ist mit nicht unbedeutender News zu rechnen und in aller Regel nicht mit negativer!

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

Abstract Number: 2538
Session Title: Clinical Immunotherapy
Presentation Title: Dendritic and T cell functions in patients with metastatic hormone-refractory prostate cancer treated with GVAX immunotherapy for prostate cancer and ipilimumab
Presentation Start/End Time: Monday, Apr 14, 2008, 1:25 PM - 1:40 PM
Location: Room 30A-C, San Diego Convention Center
Author Block: Saskia J.A.M. Santegoets, Alfons J.M. Van den Eertwegh, Sinead M. Lougheed, Anita G.M. Stam, Helen Gall, Petra E.T. Scholten, Mary B.E. Von Blomberg, Erik Hooijberg, Karin Jooss, Nathalie Sacks, Minh Nguyen, Thomas Harding, Thomas Harding, Kristen Hege, Israel Lowy, Winald R. Gerritsen, Rik J. Scheper, Tanja D. De Gruijl. VU University Medical Center, Amsterdam, The Netherlands, Cell Genesys Inc, San Francisco, CA, Medarex, Bloomsbury, NY
Abstract 2538 has been selected for inclusion in the AACR’s Annual Meeting press program and is therefore embargoed until date and time of press briefing or scientific presentation, whichever comes first. The abstract is scheduled for scientific presentation and will be posted to this site at or after the following date and time: 4/14/2008 1:00 PM.
Morgen gibts die ASCO ABstracts. Wie haben die 14 zusätzlichen Patienten der GVAX+MED-010 Studie abgeschnitten. Das ist die Studie mit den 5/6 PSA Responses und den 4/6 Responses.

Kommentaren eines Arztes zufolge (ich habe den Link nicht mehr) könnte es nur eine zusätzliche Response aus 14 zusätzlichen Patienten gegeben haben. Das wäre natürlich enttäuschend.

Ich lasse mich aber überraschen.
16 Patienten zusätzlich, 6 davon bisher vollständig behandelt. Bisher erst eine zusätzliche PSA Response, drei stabil. Leider muss man wahrscheinlich noch ein Jahr auf die vollständigen Daten der 16 Patienten der Expansion Gruppe warten. Sie werden allerdings erwartungsgemäß nicht so gut werden, wie die 5/6 PSA Responses der bisher höchsten Gruppe.

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

Background: A Phase 1 trial is underway to study GVAX immunotherapy for prostate cancer [GVAX immunotherapy (GVAX IT)] and ipilimumab (Ipi) in chemonaïve mHRPC patients (pts).

Methods: Twelve pts were treated in a dose-escalation phase for 24 weeks (wks) with bi-weekly intradermal injections of GVAX IT and monthly Ipi. Pts were enrolled in cohorts of 3; each cohort received an escalating dose of Ipi: 0.3, 1, 3 or 5 mg/kg. Sixteen pts were then enrolled in an expansion cohort to be treated with GVAX IT and 3 mg/kg Ipi.

Results:

Escalation Cohort: Median follow-up of 12 pts is 21.2 months (m). Five of six pts at the higher Ipi doses (3 and 5 mg/kg) developed Grade 2 or 3 immune-related adverse events (irAEs), including Grade 2 or 3 hypophysitis and Grade 3 alveolitis. Late onset PSA responses (declines > 50%) were seen in these 5 pts with response durations of 6.7, 8.6, 9.5, 13.8 (on-going), and 23.1 m. Four of these pts had stable disease on bone scan for at least 12 m, and up to 21 m. Multiple tumor-reactive antibodies (abs) induced by treatment were identified by serologic analysis (SEREX), including abs to filamin B, PSMA and NY-ESO-1. Biopsies of injection sites showed T cell infiltration and Granzyme B expression; these T cells are being tested for antigen-specific lytic activity.

Expansion Cohort: Sixteen pts were enrolled, 6 have completed treatment, 10 are on-going. Three pts have experienced irAEs of Grade 1 diarrhea, Grade 3 adrenal insufficiency, and a Grade 3 hepatitis that resolved with steroids. With median follow-up of 6.5 months in the 6 pts who have completed treatment, 1 pt had a PSA response (> 50% decline) and 3 obtained stable PSA, accompanied in one pt by pain relief and decrease in alkaline phosphatase. Conclusions: The GVAX IT and ipilimumab combination is active in mHRPC in this trial. IrAEs appear manageable and may correlate with anti-tumor activity. The maximum tolerated dose of the combination is not established. Follow-up on the 16 expansion cohort pts will provide data on safety, clinical activity and immunologic correlates.
Antwort auf Beitrag Nr.: 34.566.767 von Uptick08 am 23.07.08 09:51:14ach übrigens, laut die Experten stateside stehen wir hier auch am Anfang der neue Entwicklung



and it's a real long way back up...:rolleyes::cool:
jetzt hat s CEGE erwischt -75 %

Cell Genesys Halts VITAL-2 GVAX Trial in Advanced Prostate Cancer
Conference Call Scheduled for 8:30 a.m. ET Today
SOUTH SAN FRANCISCO, Calif., Aug 27, 2008 (BUSINESS WIRE) -- Cell Genesys, Inc. (Nasdaq:CEGE) today announced that it has terminated VITAL-2, the second of two Phase 3 clinical trials of GVAX immunotherapy for prostate cancer, which compares GVAX immunotherapy in combination with Taxotere(R) (docetaxel) to Taxotere plus prednisone in patients with advanced-stage prostate cancer. The Company ended the trial as recommended by its Independent Data Monitoring Committee (IDMC) which, in a routine safety review meeting held this week, observed an imbalance in deaths between the two treatment arms of the study. To date, VITAL-2 enrolled 408 patients. The IDMC based its recommendation on 114 deaths of which 67 occurred in the GVAX plus Taxotere combination treatment arm and 47 deaths occurred in the Taxotere control arm. At this time, a specific cause for the imbalance in deaths has not been identified and the IDMC reported no new safety issues for GVAX when administered in combination with Taxotere. The Company plans to fully analyze the clinical data from these patients to attempt to understand the potential cause for the higher rate of deaths observed in the GVAX immunotherapy plus Taxotere combination arm, including an assessment of potential imbalances between the two arms of the study such as baseline characteristics and prognostic factors, as well as other treatment variables. In light of the IDMC's observation with respect to VITAL-2, the Company has requested that the IDMC perform a previously unspecified futility analysis of VITAL-1, the other Phase 3 clinical trial of GVAX immunotherapy for prostate cancer. The Company expects the results of the VITAL-1 futility analysis in approximately one month.
"Patient safety is always our paramount concern and so we have immediately responded to the recommendation of the IDMC. We are currently notifying all participating clinical trial sites and regulatory agencies that enrollment of new patients into VITAL-2 has been suspended as has treatment with GVAX immunotherapy for prostate cancer of patients enrolled in the study," stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys. "Notwithstanding this disappointing outcome, we would like to acknowledge the courage and commitment of the patients and physicians who have participated in this trial."

Dr. Sherwin continued, "The observation in the VITAL-2 trial is very surprising to us, and we have therefore asked the IDMC to conduct a previously unplanned futility analysis of VITAL-1 in order to determine the overall prospects for our ongoing development program for this product. Moreover, with the cessation of VITAL-2, we expect to make commensurate adjustments to our business operations and we will provide further details regarding this in the near future. As a reminder, the company ended the second quarter of 2008 with $166 million in cash."

VITAL-2 was a multi-center, randomized, controlled Phase 3 clinical trial designed to evaluate the safety and efficacy of GVAX immunotherapy for prostate cancer used in combination with Taxotere chemotherapy compared to the use of Taxotere chemotherapy and prednisone in hormone-refractory prostate cancer (HRPC) patients with metastatic disease who are symptomatic with cancer-related pain. The primary endpoint of the trial was an improvement in survival. VITAL-2 was initiated in June 2005 and to date had enrolled 408 patients at 115 clinical trial sites located in North America and the European Union. VITAL-1, the other Phase 3 clinical trial of GVAX immunotherapy for prostate cancer, is designed to compare GVAX cancer immunotherapy as a monotherapy to Taxotere chemotherapy plus prednisone in earlier stage HRPC patients with metastatic disease who are asymptomatic with respect to cancer-related pain. The primary endpoint of the trial is an improvement in survival. In 2007, the VITAL-1 trial completed enrollment with 626 patients. In January 2008, Cell Genesys announced that the IDMC had completed a pre-planned interim analysis for VITAL-1 and recommended that the study continue, providing no further information to the company other than the recommendation to continue the trial.

Conference Call and Webcast

Members of the Cell Genesys management team will host a conference call today, Wednesday, August 27, 2008, at 8:30 a.m. ET to discuss the IDMC's recommendation. Investors may listen to the webcast of the conference call live on the investor section of the Cell Genesys website, www.cellgenesys.com. Alternatively, investors may listen to a replay of the call by dialing (800) 475-6701 from locations in the U.S. and (320) 365-3844 from outside the U.S. The call-in replay and webcast will be available for at least 72 hours following the call. Please refer to reservation number 958709.

About GVAX Immunotherapy for Prostate Cancer

GVAX immunotherapy for prostate cancer is comprised of two prostate tumor cell lines that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine that plays a key role in stimulating the body's immune response, and then irradiated for safety. GVAX immunotherapy for prostate cancer is designed to be administered through intradermal injections on an outpatient basis.

About Cell Genesys

Cell Genesys (Nasdaq: CEGE) is focused on the development and commercialization of novel biological therapies for patients with cancer. The company's lead product platform is GVAX(R) immunotherapy for cancer, which holds the potential to treat multiple types of cancer including prostate cancer, leukemia, pancreatic cancer and lung cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, California, and has manufacturing operations in Hayward, California. For additional information, please visit the company's website at www.cellgenesys.com.

Statements made herein about the company, other than statements of historical fact, including statements about the company's progress, results, findings, analysis and timing of clinical trials and preclinical programs, the timing of completion of and results from the VITAL-1 futility analysis discussed above and the nature of product pipelines are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials and research and development programs, regulatory requirements and the regulatory approval process for clinical trials, manufacture and commercialization of the company's products, competitive technologies and products, the need for and reliance on partnerships with third parties, and the need for additional financings. For information about these and other risks which may affect Cell Genesys, please see the company's reports on Form 10-Q, 10-K, and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The company assumes no obligation to update the forward-looking information in this press release.

SOURCE: Cell Genesys, Inc.

Cell Genesys, Inc.
Susan Ferris, 650-266-3200
Investor Relations







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das wars dann wohl

Cell Genesys Announces Termination of VITAL-1 Phase 3 Clinical Trial of GVAX Immunotherapy for Prostate Cancer Based on Outcome of Futility Analysis and Reports Preliminary Analysis of VITAL-2 Trial Results
Restructuring of Business Operations Implemented Conference Call Scheduled for 8:30 a.m. ET Today
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Cell Genesys, Inc. (Nasdaq:CEGE) today announced its decision to terminate the VITAL-1 Phase 3 clinical trial of GVAX immunotherapy in patients with asymptomatic metastatic hormone-refractory prostate cancer. The trial was fully enrolled in 2007 with 626 patients and compared GVAX immunotherapy to Taxotere(R) (docetaxel) chemotherapy plus prednisone. The Company terminated the trial based on the results of a previously unplanned futility analysis conducted by the study's Independent Data Monitoring Committee (IDMC) which indicated that the trial had less than a 30 percent chance of meeting its predefined primary endpoint of an improvement in survival.

On August 27, 2008, Cell Genesys announced that it had requested the IDMC conduct a futility analysis of the VITAL-1 trial following the termination of VITAL-2, the Company's other Phase 3 trial of GVAX immunotherapy for prostate cancer. In view of the termination of both the VITAL-1 and VITAL-2 trials, the Company will place on hold the further development of GVAX immunotherapy for prostate cancer pending a review of the program with its collaborator, Takeda Pharmaceutical Co. Ltd. As a result of these circumstances, Cell Genesys will reduce its staff of 290 by approximately 75 percent by year-end with further reductions anticipated in the first half of 2009 as additional activities are phased out. As of September 30, 2008, the Company had approximately $150 million in cash and currently estimates that the year-end cash will be approximately $128 million. Personnel-related restructuring charges of approximately $12.8 million are expected to be incurred in the fourth quarter of 2008. The Company plans to provide updated financial guidance during its third quarter conference call in early November.

"We are, needless to say, extremely disappointed with the outcome of the futility analysis for the VITAL-1 Phase 3 clinical trial, but remain committed to learning as much as we can about the potential role for immunotherapy in the treatment of cancer. On behalf of the Cell Genesys management team, I would like to express my deep gratitude to the courageous patients who participated in this study as well as our committed clinical trial investigators and their teams," stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys. "At this time I would also like to extend my heartfelt thanks to the hardworking and dedicated employees of Cell Genesys to whom we must now sadly say goodbye. The significant changes in our business which we are implementing today are painful but necessary, and will enable us to consider the appropriate strategic alternatives for our company."

In related news, Cell Genesys also announced the results of a preliminary analysis of the VITAL-2 Phase 3 clinical trial which, as noted above, was terminated on August 27, 2008. In contrast to the VITAL-1 study, the VITAL-2 study was conducted in patients with symptomatic metastatic hormone-refractory prostate cancer and compared the combination of GVAX immunotherapy plus Taxotere to Taxotere plus prednisone as a control. At the time this study was terminated, the IDMC reported an imbalance in deaths between the two treatment arms that was observed during a routine safety monitoring meeting of the committee. More specifically, of 114 deaths at the time of the IDMC review, 67 occurred in the GVAX immunotherapy plus Taxotere combination treatment arm and 47 in the Taxotere plus prednisone control arm. A total of 408 patients had been enrolled in the study up to that point in time. The Company has now conducted an initial analysis of the incomplete clinical trial data set that was reviewed by the IDMC in August. The analysis has revealed no apparent imbalance in patient baseline characteristics with respect to both demographic and disease prognostic factors. In addition, no significant toxicities in the GVAX immunotherapy plus Taxotere combination therapy arm were observed that could explain the imbalance in deaths and in fact, the vast majority of deaths in both treatment arms were reported as due to progression of prostate cancer. Of note, fewer treatment cycles with Taxotere were administered to patients in the GVAX immunotherapy plus Taxotere arm compared to the control arm, a difference which was statistically significant.

About VITAL-1 and VITAL-2

VITAL-1 was a Phase 3 clinical trial designed to compare GVAX cancer immunotherapy as a monotherapy to Taxotere chemotherapy plus prednisone in hormone-refractory prostate cancer patients with metastatic disease who were asymptomatic with respect to cancer-related pain. The primary endpoint of the trial was an improvement in survival. In 2007, the VITAL-1 trial completed enrollment with 626 patients. In January 2008, Cell Genesys announced that the IDMC had completed a pre-planned interim efficacy analysis for VITAL-1 and recommended that the study continue, providing no further information to the Company other than the recommendation to continue the trial. On August 27, 2008, the Company announced that it had requested the IDMC to conduct a previously unplanned futility analysis of VITAL-1. Based on the results of that analysis, the Company terminated the VITAL-1 trial, as announced today. VITAL-2 was a Phase 3 trial designed to compare GVAX immunotherapy in combination with Taxotere to Taxotere plus prednisone in hormone-refractory prostate cancer patients with metastatic disease who were symptomatic with respect to cancer-related pain. The primary endpoint of the trial was an improvement in survival. VITAL-2 was initiated in June 2005 and had enrolled 408 patients at 115 clinical trial sites located in North America and the European Union at the time of termination in late August. On August 27, 2008, the Company announced its decision to terminate VITAL-2 as recommended by its IDMC which, in a routine safety review meeting held that week to review both VITAL-1 and VITAL-2, observed an imbalance in deaths between the two treatment arms of the VITAL-2 study.

About GVAX Immunotherapy for Prostate Cancer

GVAX immunotherapy for prostate cancer is comprised of two prostate tumor cell lines that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine that plays a key role in stimulating the body's immune response, and then irradiated for safety. GVAX immunotherapy for prostate cancer is designed to be administered through intradermal injections on an outpatient basis.

Conference Call and Webcast

Members of the Cell Genesys management team will host a conference call today, October 16, 2008, at 8:30 a.m. ET to discuss this announcement. Investors may listen to the webcast of the conference call live on the investor section of the Cell Genesys website, www.cellgenesys.com. Alternatively, investors may listen to a replay of the call by dialing (800) 475-6701 from locations in the U.S. and (320) 365-3844 from outside the U.S. The call-in replay and webcast will be available for at least 72 hours following the call. Please refer to reservation number 965170.

About Cell Genesys

Cell Genesys (Nasdaq:CEGE) is focused on the development and commercialization of novel biological therapies for patients with cancer. The Company's lead product platform is GVAX(R) immunotherapy for cancer, which holds the potential to treat multiple types of cancer including prostate cancer, leukemia, pancreatic cancer and lung cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, California, and has manufacturing operations in Hayward, California. For additional information, please visit the Company's website at www.cellgenesys.com.

Statements made herein about the company, other than statements of historical fact, including statements about estimated restructuring charges and cash position, and the company's progress, results, findings, analysis and timing of clinical trials and preclinical programs, the review of the GVAX program and exploratory analyses discussed above and the nature of product pipelines are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials and research and development programs, regulatory requirements and the regulatory approval process for clinical trials, manufacture and commercialization of the company's products, competitive technologies and products, the need for and reliance on partnerships with third parties, and the need for additional financings. For information about these and other risks which may affect Cell Genesys, please see the company's reports on Form 10-Q, 10-K, and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The company assumes no obligation to update the forward-looking information in this press release.

Source: Cell Genesys, Inc.
Oft erlebt man das gerade die Werte steigen bei denen
das Board sehr ruhig ist.

CEGE ist wahrscheinlich so ein Wert.

Habe gestern mal zu 0,325 welche gekauft.

Scheint weiter aufwärts zu gehen.:lick::lick:
Glaube in Germany kriegt es kaum einer mit!:yawn::yawn::laugh:

Heute scheint noch was zu kommen TH sehe ich bei über 0,6 $
Na da war ich wohl zu optimistisch.
Die Quartalszahlen sind aber ok und haben sich zu VJ stark
verbessert.

12,5 MIO Short machen hier alles zunichte und es wird wohl wieder
abwärts gehen!:mad::mad:
Das Ask sieht ja heute super aus- da steht 10.-$:lick::lick:
Na wenn es wenigstens grün wird bin ich erstmal zufrieden.

Man strebt einen 80%tigen Personalabbau bis Jahresende an.
60% sind schon realisiert.(=116 MA heuer)(58MA am 31.12.2008)
das senkt die Kosten dramatisch
In 2009 will man weiteres Personal abbauen.

118-120 MIO Cash wird man bis Jahresende (150 MIO jetzt).

Je Share steht ein Eigenkapital von 1,78$:eek: und am Jahresende von 1,42$ gegenüber!:eek:

Zudem strebt man einen Merger an und könnte sich vorstellen
es mit Takeda Pharmaceutical Company Limited
einen bisherigen Auftraggeber o. anderen zu machen .

Schade das die Erprobungsphasen für das Prostatamittel gecancelt
wurden denn damit hätte man einen Durchbruch geschafft.

Aber es stehen noch andere Dinge an wie z.B Alzheimer
Präparate wo gerade 4,5 MIO zu weiteren Forschungszwecken in die
Kasse gespült wurden.

GLTA;)
Hier könnte es so enden wie bei Atherogenics (Chapter 11).Leute,ich war selber drin in atherogenics,ihr glaubt garnicht wie schnell hier die Lichter ausgehen.Cell Genesys hat einen ähnlich hohen verschuldungsgrad wie ihn atherogenics hatte ....

MFG
Chali :look:
Antwort auf Beitrag Nr.: 35.882.556 von Chalif am 08.11.08 12:36:28Ich denke eher, dass es hier zu einem ordentlichen Rebound kommen wird (nur meine Meinung). Wie´s aussieht sind die Quartalszahlen raus, der Kurs hat einen kurzen Einsturz hingelegt und hat dennoch höher geschlossen als wie gedacht,... I stay long :cool:
Das mit dem ordentlichen rebound glaubst du doch selber nicht :rolleyes: !Alle Drugs von Cell Genesys sind gescheitert,Leute sind in den Phase 2 Tests gestorben,hohe Verschuldung etc.

Hier ist nichts meht zu holen,nichts wie raus .. :eek::eek::eek: !!
Antwort auf Beitrag Nr.: 35.892.417 von Chalif am 09.11.08 15:50:52o.k. dann erklär mir doch mal den Hype der letzten Tage in den U.S.A. ;-) Wie erklärst du dir diese täglichen Gewinne??? Ich denke, hier ist mehr zu holen als wie manche glauben möchten...
Antwort auf Beitrag Nr.: 35.892.417 von Chalif am 09.11.08 15:50:52Hier sind noch etliche Short .
Ich stelle fest das es wahrscheinlich ist, das Du dazu gehörst
oder zum bashen abgestellt wurdest.

Du erwähnst nämlich gar nicht das die Prostatastudie/Testreihe deswegen abgebrochen wurde weil es zu den bisherigen Mittel keine sigifikant positiven Ausschläge gab.
Aber auch da verstarben die Patienten!

Am Mittwoch gibt es eine Konferenz und CEGE sucht einen
Mergerkanditaten .
Vielleicht hat sich im Vorfeld schon etwas abgezeichnet
wie sonst ist der EOD run am Freitag zu erklären ?

Das Quartalsergebnis ist aufgrund der Einflüsse des Geldflusses für die Testreihe des Prostatakrebsmittels o.K was aber nun entfällt.
Man hat sofort 60% MA entlassen und ist am 31.12.2008 auf 80 %.

Den Rest des Unternehmens will man mit einem anderen Konzern verschmelzen.Für die Alzheimer Studie gab es gerade 4,5 MIO
an Cash welches die Glaubwürdigkeit der AG nicht gerade
verschlechtert!;);)

Es gibt noch Assets und am Jahresende stehen ca.
120 MIO $ auf der Haben Seite!

Ein Kurs von 1,4$ ist gerechtfertigt.
Mit Shorties die nun Angst haben geht es evtl. auch höher!;)
Cell Genesys and Takeda terminate collaboration agreement
Thursday December 04, 2008 09:38:41 EST
Dec 04, 2008 (Datamonitor via COMTEX News Network)


Cell Genesys, a biotechnology company, and Takeda Pharmaceutical Company, together with its wholly owned subsidiary Millennium Pharmaceuticals, have mutually agreed to suspend the further development of Gvax immunotherapy for prostate cancer.

Takeda has also ended the collaboration agreement with Cell Genesys for the development and commercialization of the product.

Under the terms of the agreement, Takeda will return all commercial rights to Gvax immunotherapy for prostate cancer to Cell Genesys and make certain wind-down payments to Cell Genesys in connection with the phasing out of the remaining clinical development activities.
moin

After Hours
Last: $ .45 After Hours
High: $ .50
After Hours
Volume: 40,687 After Hours
Low: $ .44

hier noch ein kleiner auszug aus'm yahoo forum

3 NEW REPORTS CEGE NEWS TODAY 15-Apr-09 09:00 pm

$84 IN REPORTS FOR CEGE CAME OUT TONIGHT. CEGE HAS NEWS FOR THE MOVERS. REPORTS AREN'T MADE FOR COMPANIES WHICH HAVE NOTHING.
Antwort auf Beitrag Nr.: 37.005.832 von Marchella am 20.04.09 22:27:33Würde lieber die Finger von lassen ...Fakt ist Gvax wurde eingestellt finito nada und die zusammenarbeit mit Takeda wurde auch beendet hier ist nix mehr Zukunft außer man will zocken ..

Harry A. can't seem to let Cell Genesys (CEGE Quote) die a quiet, peaceful death.

"If in your opinion Cell Genesys is done, then explain why Leroy Kopp [Kopp Investment Advisors] increased his position by buying 600,000 shares in February? Do you think they are doing this to throw money away? You seem to know so much, just like Cramer does. To me, you and him are alike, you both pump and bash for your hedge fund buddies."

I don't know why Kopp is buying more Cell Genesys, if indeed the firm is buying. (I'll take Harry at his word.) But here is what I do know about Cell Genesys: I first raised serious questions about the company's cancer vaccine technology in February 2004 when the stock traded in the teens. I continued to warn readers off the stock throughout 2007 before the company's prostate cancer vaccine blew up spectacularly. You can read the highlights here and here and here.

Today, Cell Genesys is an empty shell of a company with a stock that trades for around 20 cents. Drug development is on hold, the employee count is down to 21, and the company is looking for a buyer.

So, I wish Kopp and Harry good luck with Cell Genesys. I think my bearish call performed exceedingly well.
Antwort auf Beitrag Nr.: 37.005.901 von BrauchGeld am 20.04.09 22:37:19Guten Morgen,

kann es sein das CEGE beim Anlegen der GVax Studie damals einen Fehler gemacht hat?

Schließlich traten die Todesfälle in Kombination mit Taxotere auf, also bei Patienten die schon stark vorbehandelt und austherapiert waren.

Der vermutete Erfolg bei Provenge könnte GVax eine neue Dimension geben, z.b. beim ausarbeiten einer neuen Studie. Immerhin hat Cell Genesys keine Schulden und rund 60 Mio in Cash.

Ich weis nicht ob der Anstieg gestern vielleicht doch einige zu der Annahme veranlaßt hat.
Dieser Satz hier aus dem Artikel bzgl. der Studienaufgabe läßt mich aufhorchen.

Earlier-stage trials have shown that patients taking GVAX lived for about 35 months _ or longer, if they had an immune response to the drug _ compared with about 25.2 months for Provenge and, Pantginis said, 18 or 19 months for the standard treatment, Sanofi-Aventis' Taxotere.

Wenn CEGE deutlich über 1 Dollar steigt wäre das für mich ein Zeichen das vielleicht darüber nachgedacht wird.
Anstieg die letzten Tage mit hohem Volumen und teilweise beträchtlichen Orders ist für mich immer ein gutes Indiz
Der Anstieg ist also fundamental begründet und nicht nur als Zock zu sehen

good trade
:)
Nach der Beendigung der Zusammenarbeit mit Takeda Ch. wird das Interesse durch die DNDN Meldung an einer Vaccine Therapie wieder steigen. Vielleicht kriegen wir hier bald die Meldung das ein großer Pharma Interesse an der Fortführung des Programms hat.
Warum sollte sonst CEGE so stark und unter so einem hohen Volumen steigen, wenn die immer noch Däumchen drehen?
Antwort auf Beitrag Nr.: 37.006.914 von Larry_1 am 21.04.09 09:02:11Anstieg die letzten Tage mit hohem Volumen und teilweise beträchtlichen Orders ist für mich immer ein gutes Indiz
Der Anstieg ist also fundamental begründet und nicht nur als Zock zu sehen


Ich denke es hat einfach damit zu tun das CEGE weit unter Cash notiert sonst sehe ich nichts was den Anstieg begründet .

Balance Sheet...
Total Cash (mrq): 83.21 M$
Total Cash Per Share (mrq): 0.959 << CEGE ist aktuell bei 0,68 $
:laugh:

BINGO ich habs doch gesagt ....


Genes Identified That Enhance Tumor Cell Sensitivity to CTI's Cancer Drug Brostallicin

* Tuesday April 21, 2009, 1:30 am EDT

*
Buzz up!
* Print

Related:

* Cell Therapeutics, Inc.

Identifies potential clinical trial strategies for personalized approach to cancer treatment
Related Quotes
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CTIC 0.31 0.00
Chart for Cell Therapeutics, Inc.
{"s" : "ctic","k" : "c10,l10,p20,t10","o" : "","j" : ""}

SEATTLE, April 21 /PRNewswire-FirstCall/ -- Systems Medicine, LLC (SM), a wholly-owned subsidiary of Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC), presented data from a preclinical study, which utilized RNA interference (RNAi) and bioinformatics to identify genetic markers - "contexts of vulnerability" - that enhance the anti-tumor response to the experimental drug candidate brostallicin, at the 2009 American Association for Cancer Research (AACR) annual meeting in Denver, Colorado. "Contexts of vulnerability" refers to the genetic configuration in a patient's tumor that makes it susceptible to a specific drug thus providing the genetic rationale for targeted therapy. The study's objective was to identify molecular determinants of brostallicin's anti-tumor response that could guide clinical development and drug combination studies by incorporating an integrated pharmacogenomics approach. The study was conducted by SM in collaboration with the Translational Genomics Research Institute's Pharmaceutical Genomics Division in Scottsdale, Arizona.

"This study has identified certain patient groups which might be more likely to benefit from therapy with brostallicin and have been invaluable in assisting us in identifying promising clinical development strategies for future development of this novel drug candidate," said Jack Singer, M.D., Chief Medical Officer of CTI. "Ultimately, we believe this approach should shorten the clinical development time and increase the success rate by bringing us closer to being able to offer the right drug to the appropriate patient."

Brostallicin is a small-molecule chemotherapeutic agent with a unique mechanism of action -- it binds to the minor grooves located in the DNA double helix. To identify genes associated with cellular response to brostallicin, a high-throughput RNA interference screen was performed in selected ovarian cancer cell lines. RNA interference is a cellular process that results in the targeted knockdown of specific genes. The current screen assayed the effect of over 7,000 individual gene knockdowns, representing the "druggable" genome, on brostallicin response.

The identified genes, representing unique contexts of vulnerability to brostallicin, converged on cellular concepts relating to DNA repair and chromosome modification. These findings were further extended and confirmed in breast cancer cell lines, wherein the knockdown of specific genes involved in these concepts, mentioned above, resulted in an increased response to brostallicin.

To substantiate the brostallicin response observed in the RNAi studies, drugs that target selected genetic targets were tested for synergistic activity in combination with brostallicin. The outcome of this validation work has identified important contexts and rational drug combinations that will be critical for the clinical development of brostallicin.

To review the poster and see more detailed information about the study, please go to http://www.celltherapeutics.com/investor_updates.

About Brostallicin

Brostallicin, a novel synthetic second-generation DNA minor groove binder, has shown potent cancer killing activity and has demonstrated synergism in combination with standard cytotoxic agents as well as with newer targeted therapies in preclinical experimental tumor models. Brostallicin binds covalently to DNA within the DNA minor groove, interfering with DNA division and leading to tumor cell death. More than 200 patients have been treated with brostallicin in single-agent and combination studies. Brostallicin had predictable and predominantly hematologic toxicities. Activity was demonstrated in a number of solid tumor types. A phase II study of brostallicin in relapsed/refractory soft tissue sarcoma met its pre-defined activity and safety hurdles and resulted in a first-line phase II study that is currently being conducted by the European Organization for Research and Treatment of Cancer (EORTC).

About Systems Medicine (SM)

In July 2007, CTI acquired Systems Medicine, a privately held oncology company, in a stock-for-stock merger. SM applies a systems biology approach to drug development, combining pharmacogenomics and bioinformatics with experienced preclinical, clinical, and regulatory expertise to find and exploit a specific cancer's 'context of vulnerability.' Specifically, SM defines the molecular and genetic alterations (context) that cause cancer cells to be particularly sensitive (vulnerable) to a drug or combination of drugs--the "context of vulnerability."

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.CellTherapeutics.com.

Sign up for email alerts and get RSS feeds at our Web site, http://www.celltherapeutics.com/news_subscription_service

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of brostallicin include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with brostallicin in particular, including, without limitation, the potential failure of the preclinical results to predict results in clinical trials, the potential failure of the clinical results to predict the safe and effective treatment of cancer, the potential failure of brostallicin to prove safe and effective for treatment of solid tumors particularly ovarian or colon cancers, determinations by regulatory, patent, and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing, and selling brostallicin, and the risk factors listed or described from time to time in the CTI's filings with the Securities and Exchange Commission including, without limitation, the CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: media@ctiseattle.com
www.CellTherapeutics.com/press_room

Investors Contact:
Ed Bell
T: 206.282.7100
Lindsey Jesch Logan
T: 206.272.4347
F: 206.272.4434
E: invest@ctiseattle.com
www.CellTherapeutics.com/investors

Medical Information Contact:
T: 800.715.0944
E: info@askarm.com
Das ist ja der Hammer
die Cege bringt mir jetzt seit ca. 2 Jahren immer wieder Extreme Gewinne.
Allerdings trade ich diese Aktie nur, d.h. heute werde ich dann vermutlich wieder rausgehen.

Bin in der Arbeit...
Kannst du paar deutsche Interpretationen geben, was jetzt hier Sache ist??
Ich bin auch noch auf der Arbeit. Heute abend muss ich mich mal näher einlesen. Aber Insider haben da im Vorfeld gekauft. Anders kann man die Kursentwicklung und die heutige Meldung nicht werten.

Bei CEGE gehts weiter und mit reichlich Cash und ohne Schulden... :D