Bioniche Phase II Bladder Cancer Trial Results Published in The Journal of Urology
- results from this trial supported entry into Company's current Phase III bladder cancer program -
BELLEVILLE, ON, February 18, 2009 /PRNewswire-FirstCall/ - <!-- cpurl -->Bioniche Life Sciences<!-- /cpurl --> Inc. , a research-based, technology-driven Canadian biopharmaceutical company, today announced that The Journal of Urology has published an article summarizing the Phase II clinical trial results for the Company's proprietary Mycobacterial Cell Wall technology in bladder cancer.
The article, entitled "Intravesical Mycobacterial Cell Wall-DNA Complex in the Treatment of Carcinoma In Situ of the Bladder After Standard Intravesical Therapy has Failed", was co-authored by Drs. Alvaro Morales (Queen's University - Kingston, Ontario, Canada), Kiran Phadke , and Gary Steinhoff (Vancouver Island Health Authority - Victoria, British Columbia, Canada). The Phase II trial resulted in a complete response rate in the intent-to-treat population of 27.3% at weeks 12 and 26 at a 4 mg dose and a 46.4% response at the same two points in patients receiving an 8 mg dose. Complete response was defined as no evidence of disease as determined by cystoscopy, biopsy and cytology. The product was well tolerated by both dose groups, with 90% of all adverse events being mild to moderate in severity.
"We concluded that Mycobacterial Cell Wall-DNA Complex has shown antineoplastic (anticancer) activity in patients with bladder cancer with less toxicity than that associated with bacillus Calmette-Guerin (BCG) administration," said Dr. Alvaro Morales, Director of the Centre for Advanced Urological Research and Professor in the Department of Urology, Queen's University, Kingston, Ontario, Canada. "Safety concerns exist with BCG because it is a live mycobacterium and its use is associated with a number of local and systemic side effects, as well as the potential for proliferation and systemic dissemination."
The article depicts Phase II exploratory work that has supported the entry of MCC into a Phase III clinical program that has been reviewed and approved by the U.S. Food and Drug Administration (FDA). The first of two Phase III FDA-approved registration trials is nearing enrolment completion. In this trial, patients with non-muscle-invasive bladder cancer whose cancer is specifically refractory (unresponsive) to BCG are receiving a formulation of Mycobacterial Cell Wall-DNA Complex, trademarked Urocidin, in an open label trial. Thirty-one urology centres in North America are participating in this trial and recruitment of 105 evaluable patients is expected to be completed by the end of March, 2009.
Data from the full cohort of evaluable patients, coupled with additional safety information to be collected from a comparative trial, will allow efficacy results to be reported one year after recruitment is completed. These results, coupled with additional safety data, may be used to support regulatory submissions under the FDA's Accelerated Approval program.
This indication was given Fast Track designation by the U.S. Food and Drug Administration (FDA) in April of 2006. The Company commenced this trial in November, 2006. An investigators' meeting was held in April, 2007 and the 31st site was initiated in June, 2008.
Data Safety Monitoring Committee
The Data Safety Monitoring Committee held its seventh scheduled meeting regarding this clinical trial last week. The role of this independent body is to confirm that the safety of enrolled patients is being appropriately addressed and that, from an efficacy point of view, there is an appropriate basis for continuing the trial. After its meeting, the Committee has again recommended that Bioniche "continue the trial unmodified until the next scheduled or triggered meeting". The next scheduled meeting of the Committee will be held in three months.
Second Phase III Registration Trial
Bioniche plans to conduct a second registration trial which will directly compare the efficacy and safety of MCC with BCG in the treatment of non-muscle-invasive bladder cancer. In September, 2007, the Company announced that an agreement has been reached with the U.S. FDA under the Special Protocol Assessment (SPA) procedure on the design of the trial, including its endpoints, data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a Biologics Licensing Application (BLA). An SPA gives a clear pathway to registration of MCC when the trial endpoints are achieved. This trial received Fast Track designation by the FDA last year. The Company expects to start this trial at such time as it has a marketing partner in place.
MCC is a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. It is formulated as Urocidin(TM) for the treatment of bladder cancer, where it is administered by trans-urethral catheter directly into the bladder, coming into contact with immune system cells and bladder cancer cells. MCC is undergoing preclinical evaluation as a treatment for peritoneal carcinomatosis associated with colon and ovarian cancer.
About The Journal of Urology
Established in 1917, The Journal of Urology (www.jurology.com) is the official journal of the American Urological Association (www.auanet.org). It is the most widely read and highly cited journal in the field. It brings to its readership all the clinically relevant information needed to stay at the forefront of this dynamic field. This top-ranking journal presents investigative studies on critical areas of research and practice, survey articles providing short condensations of the best and most important urology literature worldwide and practice-oriented reports on interesting clinical observations.
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 approximately 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company's primary goal is to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health. Bioniche has been named one of the Top 50 Best Small and Medium-Sized Employers in Canada for 2009. 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.
CONTACT: Jennifer Shea, Vice-President, Communications, Investor &Government Relations, Bioniche Life Sciences Inc., Telephone: (613)966-8058, Cell: (613) 391-2097, Jennifer.Shea@Bioniche.com
Ticker Symbol: (Toronto:BNC)
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Posted: February 2009