- 6th Data Safety Monitoring Committee meeting held this week -
BELLEVILLE, ON, Nov. 17 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. , a research-based, technology-driven Canadian biopharmaceutical company, today announced that its first Phase III clinical trial with a formulation of Mycobacterial Cell Wall-DNA Complex (MCC), trademarked Urocidin, for the treatment of bladder cancer, has been authorized to continue the trial unmodified.
The Data Safety Monitoring Committee held its sixth 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.
The protocol calls for 105 evaluable patients to be enrolled in the trial. These are patients with non-muscle-invasive bladder cancer that is refractory (unresponsive) to bacillus Calmette-Guerin (BCG) therapy. BCG, the standard of care for non-muscle-invasive bladder cancer, has limited efficacy, especially as second-line therapy. It is associated with a number of treatment-limiting side effects that include the potential for both local (bladder) and systemic mycobacterial infections.
Recruitment of patients continues in our first pivotal Phase III clinical trial with Urocidin. In this trial, patients with non muscle-invasive bladder cancer whose cancer is specifically refractory (unresponsive) to BCG will receive Urocidin in an open label study. Thirty-one urology centres in North America are participating in this study and enrolment is expected to be completed in the first quarter of calendar 2009.
The patients at participating sites that are eligible and who choose to participate in this trial represent a very small subset of the BCG refractory patient population in North America. In order to satisfy regulatory authorities, the trial protocol is quite specific and patients must meet numerous criteria to be eligible. A significant proportion of patients who qualified for inclusion in the study based upon local pathology assessment (per normal clinical practice) were later found to have cancer of a different grade or stage when assessed by a central pathologist (per the trial’s protocol) and will have to be replaced. These patients will still be allowed to continue treatment and will be evaluated for safety and efficacy.
Ultimately, 105 evaluable patients must be enrolled in the trial, and disqualifications require the Company to recruit replacement patients. Data from the 105 evaluable patients involved in the trial, coupled with additional safety information to be collected from a comparative trial, will allow full results to be reported one year after recruitment is completed for the efficacy and safety datasets. These results may also support regulatory submissions under U.S. Food and Drug Administration (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 validated in June, 2008.
Bioniche is planning 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. Food and Drug Administration (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 study received Fast Track designation by the FDA earlier this year.
About MCC
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.
Other Corporate News
At the Bioniche Life Sciences Inc. Annual and Special Meeting of Shareholders on Thursday, November 6, 2008, shareholders elected a new Director, Albert Beraldo, President of Alveda Pharmaceuticals Inc. The shareholders also re-elected Stanley Alkemade, Peggy Cunningham, Pierre-Yves Desbiens, Jim Johnson, Graeme McRae and Lyle Vanclief. Dr. Lorne Babiuk, Dr. Michel Bazinet and Connie Roveto did not stand for election due to time constraints. Additionally, Dr. Armen Aprikian, Head of the Division of Urology, Department of Surgery, McGill University & Interim Chief of the Department of Oncology, McGill University Health Centre agreed to participate on the Board of Directors as an Observer.
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 Canada’s Top Ten Life Sciences Companies for 2008. 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
