Bioniche - wann kommen die Phase-III-Daten - 500 Beiträge pro Seite

[truberdixx]

Hallo zusammen,

bei Bioniche sollten die Phase-III-Daten im 2. Quartal 2010 veröffentlicht werden, dann hieß es 3. Quartal und seither kam gar keine Meldung mehr. Jezt sind wir schon im 1. Quartal 2011 und es sind immer noch keine Daten veröffentlicht und das bei einer so vergleichsweisen kleinen Studie.

Hat irgendjemand eine Ahnung 1. warum das so lange geht und 2. bis wann denn mit den Ergebnissen zu rechnen ist?

[Sebi-K]

gute frage, das gleiche habe ich mich auch schon gefragt, finde aber nirgendwo eine antwort dazu....da bleibt uns nur warten

[janissary]

Antwort auf Beitrag Nr.: 40.905.770 von Sebi-K am 21.01.11 20:24:32

Wann die Phase-III-Daten kommen ist noch nicht bekannt. Aber dafür dieses hier:

By The Canadian Press

BELLEVILLE, Ont. - Sales at Bioniche Life Sciences Inc. (TSX:BNC) slipped in its fiscal 2011 second quarter, leading to a decline in revenue and an quarterly net loss, the company said Thursday.

The biopharmaceutical company, based in Belleville, Ont., reported a net loss of $2.1 million or three cents per share for the quarter ended Dec. 31. The loss reversed year-earlier profits of $2.7 million or four cents per share.

Bioniche booked quarterly revenue of $11.4 million, down from the $13.8 million posted in the comparable quarter of fiscal 2010.

Revenue was dragged down by a decline in sales, which sagged to $6.1 million from $7 million a year ago. Licensing revenue tumbled to $4.4 million from $6.8 million.

In Thursday trade on the Toronto stock exchange, Bioniche shares closed up eight cents at $1.42.

Das kann hier noch eine ganz spannende Kiste werden. Deswegen: Abwarten und überraschen lassen

[Fruehrentner]

First Patient Enrolled in Second Phase III Clinical Trial of Urocidin(TM)

16 Feb 2011

450 patients to be enrolled at approximately 120 global sites

CHADDS FORD, PA, USA, and BELLEVILLE, Canada I February 16, 2011 I Endo Pharmaceuticals (Nasdaq: ENDP) and Bioniche Life Sciences Inc. (TSX and ASX: BNC), today announced enrollment of the first patient in the second Phase III clinical trial of Urocidin(TM). The trial is a randomized, active-controlled, open-label, multi-center study with a blinded endpoint assessment designed to compare Urocidin(TM) with mitomycin C in the intravesical treatment of patients with BCG recurrent or refractory non-muscle-invasive bladder cancer.

It is estimated that 450 patients will be enrolled for this new trial at approximately 120 clinical sites worldwide. Summary details of the study protocol are now publicly available via the U.S. National Institutes of Health (NIH) clinical trial registration service at http://www.clinicaltrials.gov/.


About Bladder Cancer

In North America, bladder cancer is the fourth most common cancer in men and the fifth overall between both men and women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year and 500,000 living patients have been affected. In Europe, more than 100,000 patients are newly diagnosed each year. Bladder cancer is frequently a recurrent disease, with some cases becoming refractory to available chemotherapeutic or immunotherapeutic agents and leading to cystectomy (bladder removal) or death. Approximately 70 percent of bladder cancer patients have the non-muscle-invasive form of bladder cancer. Collectively across the U.S., Europe and Japan, approximately 350,000 non-muscle-invasive bladder cancer patients are newly diagnosed or have a recurrence each year.

Non-muscle-invasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin(TM) is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.

About Urocidin(TM)

Urocidin is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. Urocidin(TM) is formulated for the treatment of bladder cancer, where it is administered by trans-urethral catheter directly into the bladder. The agent is then able to directly interact with the cells of the immune system and bladder cancer cells. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a C$9.6 million loan to be repaid by Bioniche from sales.

About the Endo-Bioniche Partnership

Endo holds exclusive global rights to develop and market Bioniche's patented formulation of Mycobacterial Cell Wall-DNA Complex (MCC), Urocidin(TM), being developed for the intravesical treatment of non-muscle-invasive bladder cancer.Under the licensing agreement, Bioniche received an up-front payment of US$20 million in July 2009, and became eligible to receive an additional US$110 million in milestone payments. Milestones are announced as they are achieved and, with its exclusive manufacturing supply contract, Bioniche provides clinical trial material and will also receive a net-sales-based revenue stream upon product approval.

About Bioniche Life Sciences Inc.

Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs over 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. For more information, please visit http://www.bioniche.com/.

About Endo

Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries HealthTronics, Inc. and Qualitest Pharmaceuticals, please visit http://www.endo.com/.

Bioniche Forward-Looking Statements

Except for historical information, this news release may contain forward-looking statements that reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.

SOURCE: Endo Pharmaceuticals

[truberdixx]

Antwort auf Beitrag Nr.: 41.058.056 von Fruehrentner am 17.02.11 13:53:12

ist hier noch jemand an board?

[Fruehrentner]

Urocidin Phase III Clinical Trial Results Presented at AUA Conference in Washington, D.C.

18 May 2011

Podium presentation by Dr. Alvaro Morales, Global Principal Investigator

CHADDS FORD, PA, USA and BELLEVILLE, Ontario, CANADA | May 17, 2011 |
Endo Pharmaceuticals and Bioniche Life Sciences today presented Phase III trial results for the intravesical formulation of Mycobacterial cell wall-DNA complex (MCC), known as Urocidin™, during a podium presentation at the 2011 American Urological Association annual meeting in Washington, D.C. The preliminary results from the interim analysis of this prospective trial indicate that Urocidin™ may provide an alternative to cystectomy for patients with bacillus Calmette-Guerin (BCG) refractory non-muscle invasive bladder cancer (NMIBC).

The preliminary results were generated from an interim analysis in an ongoing Phase III trial with Urocidin™ in the treatment of NMIBC that is refractory to BCG and at high risk of progression.

The Results

A total of 129 patients were enrolled from 25 centers in the U.S. and Canada, with high grade papillary tumors and/or carcinoma in situ (CIS) and having failed to respond to one or more courses of BCG. According to the preliminary results the overall one-year disease-free survival (DFS) rate was 25 percent. DFS is defined as lack of recurrence or progression to muscle-invasive disease, as confirmed by biopsy. The one-year DFS rate was 35 percent for patients with only papillary tumors and 21 percent for patients with carcinoma in situ (CIS) with or without papillary tumors. The preliminary results indicate that intravesical administration of Urocidin™ was well tolerated.

Ongoing Phase III Clinical Program with Urocidin™

Summary details of a Phase III clinical trial protocol with Urocidin™ being conducted by Endo are publicly available via the U.S. National Institutes of Health (NIH) clinical trial registration service at http://www.clinicaltrials.gov. This trial is actively enrolling eligible NMIBC patients.


About Bladder Cancer

In North America, bladder cancer is the fourth most common cancer in men and the fifth overall between both men and women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year and 500,000 living patients have been affected. In Europe, more than 100,000 patients are newly diagnosed each year. Bladder cancer is frequently a recurrent disease, with some cases becoming refractory to available chemotherapeutic or immunotherapeutic agents and leading to cystectomy (bladder removal) or death. Approximately 70 percent of bladder cancer patients have the non-muscleinvasive form of bladder cancer. Collectively across the U.S., Europe and Japan, approximately 350,000 non-muscleinvasive bladder cancer patients are newly diagnosed or have a recurrence each year.

Non-muscleinvasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin™ is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.

About Urocidin™

Urocidin™ is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that appears to have a dual mode of action: immune stimulation and direct anticancer activity. Urocidin™ is being investigated for the treatment of non-muscle invasive bladder cancer, where it is administered by trans-urethral catheter directly into the bladder. The agent is then able to directly interact with the cells of the immune system and bladder cancer cells. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a C$9.6 million loan to be repaid by Bioniche from sales.

About the Endo-Bioniche Partnership

Endo holds exclusive global rights to develop and market Bioniche's patented formulation of Mycobacterial Cell Wall-DNA Complex (MCC), Urocidin™, being developed for the intravesical treatment of non-muscle invasive bladder cancer. Under the licensing agreement, Bioniche received an up-front payment of US$20 million in July 2009, and became eligible to receive an additional US$110 million in milestone payments. Milestones are announced as they are achieved and, with its exclusive manufacturing supply contract, Bioniche provides clinical trial material and will also receive a net-sales-based revenue stream upon product approval.

About Bioniche Life Sciences Inc.

Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs more than 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. For more information, please visit www.Bioniche.com.

About Endo Pharmaceuticals Inc.

Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries HealthTronics, Inc. and Qualitest Pharmaceuticals, please visit http://www.endo.com/.

SOURCE Endo Pharmaceuticals Inc.

[Danny767]

Ist hier noch jemand mit investiert und wie seht Ihr die Zukunft?

[Danny767]

..Bioniche Life Sciences Inc. Moves Closer to Market Launch of Immunocidin™
Press Release: Bioniche Life Sciences Inc. – Mon, Jul 23, 2012 4:00 PM EDT....Email
Share0Print.....Companies:...Bioniche Life Sciences Inc.BIONICHE CDI 1:1 . ..RELATED QUOTES.
.Symbol Price Change
BNC.TO 0.52 0.00

..........
-Canadian launch expected in September, 2012-

BELLEVILLE, ON, July 23, 2012 /CNW/ - Bioniche Life Sciences Inc. (BNC.TO) (BNC.AX), a research-based, technology-driven Canadian biopharmaceutical company, today announced that the first of two canine oncology products has received approval by regulators in both the U.S. and Canada . Market launch activities are currently underway with an expectation to have product available in September, 2012 in Canada , followed by a U.S. launch before the end of the calendar year.

The product - ImmunocidinTM - is based on the Company's proprietary mycobacterial cell wall technology, the same platform from which its Phase III product for human bladder cancer (UrocidinTM) was derived. ImmunocidinTM is indicated as an immunotherapy for the intratumoral treatment of mixed mammary tumor and mammary adenocarcinoma in dogs.

"We are pleased to be nearing market launch for the first of two important canine oncology products in a market where there are few registered veterinary products," said Andrew Grant , President, Bioniche Animal Health (global). "Canine cancer is the leading disease-related cause of death in dogs, with approximately one in four dying of cancer. Human chemotherapies are commonly used for treatment, but this requires special handling and the side effects can vastly diminish the dog's quality of life."

About Canine Cancer

Where a treatment is used in dogs with cancer, it can involve surgery, radiation therapy or chemotherapy. Radiation therapy is difficult to access and chemotherapy is highly toxic, requiring handling by specially trained personnel, which many companion animal veterinary clinics do not have. These therapies have similar side effects in animals as in humans (anorexia, nausea, hair loss, anemia, major infections, etc.). Surgery and therapy costs for dogs with cancer can range from $3,000 to $15,000 and above, depending upon type and stage of cancer, number and type of primary and supportive treatments required, the age and condition of the dog, and the location of treatment (travel costs).

Second Bioniche Canine Cancer Therapy

Through the course of development of UrocidinTM for human bladder cancer, the mycobacterial cell wall technology was extensively tested in a number of human cancer cell lines, including bladder, ovarian, colon, gastric and breast, as well as in canine cancer cell lines, including osteosarcoma and mammary, where it was shown to possess direct anticancer activity with apoptosis (programmed cell death) in cancer cells. The technology has also been demonstrated to be synergistic with chemotherapeutic agents. Further, a large amount of toxicity work has been completed to ascertain the product's safety for human use. One of the safety studies involved a number of dogs in an intravenous (I.V.) safety study, required to support the Phase III UrocidinTM program and to support registration. After administration of large doses of the product to these dogs, there were few side effects.

This work has led to further analysis of an I.V. therapy for canine cancer based on the same technology. Chemotherapy treatment commonly causes cytopenia, a deficiency in the number of cellular elements in the blood, including white blood cells as well as erythrocytes and platelets.

Clinical studies show that a single dose of the second product following chemotherapy treatment in healthy dogs restores the number of white blood cells in the dog to normal levels within 24 to 48 hours with few side effects. The Company is undertaking dose confirmation studies prior to conducting final licensing studies. It is anticipated that this work will be completed over the next 6 to 9 months, after which regulatory approvals will be sought, first in North America , then in Australia and Europe .

About Bioniche Life Sciences Inc.

Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary and innovative products for human and animal health markets worldwide. The fully-integrated company employs more than 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company's primary goal is to develop and commercialize products that advance human or animal health and increase shareholder value.

Bioniche Animal Health develops, manufactures and markets veterinary biopharmaceutical products worldwide. In North America , it has development, manufacturing and marketing facilities in Belleville, Ontario, Canada , Athens , Georgia , U.S.A. and Pullman, Washington, U.S.A. In Australia , business is conducted from two sites: Sydney, New South Wales, where sales and marketing, customer support and technical service are located; and Armidale, New South Wales, where research, development and manufacturing facilities are located.

Bioniche Life Sciences Inc. has been named one of the Top 50 Best Small and Medium-Sized Employers in Canada for 2011. For more information, please visit www.Bioniche.com.

Except for historical information, this news release may contain forward-looking statements that reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.