-Phase I/II studies summarized-
BELLEVILLE, ON, Nov. 24 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. , a research-based, technology-driven Canadian biopharmaceutical company, presented data about its proprietary Mycobacterial Cell Wall-DNA Complex (MCC) - trademarked Urocidin - to an international audience of urologists at the 2008 Societe Internationale d’Urologie (SIU) Congress in Santiago, Chile on Saturday.
The presentation, entitled, “Patients Age in Bladder Cancer Immunotherapy Response and Adverse Events: MCC Experience”, was presented by Dr. Francois Charette, Senior Vice-President and Chief Medical Officer of Bioniche Life Sciences Inc.
In his presentation, Dr. Charette summarized the results of Phase I/II clinical studies with MCC, which involved 130 patients with Carcinoma in situ (CIS) high grade bladder cancer, with or without papillary lesions. The majority of these patients (62%) had been previously treated with bacillus Calmette- Guerin (BCG). The average age of the study participants was 73 years. The SIU presentation concluded that MCC has an excellent safety profile in older patients. Furthermore, the complete response rate, a measure of efficacy for bladder cancer, was similar between older and younger patients.
The SIU is the world’s only truly international professional organization serving the global community of urologists. Founded in Paris in 1907, the SIU Central Office now serves its members from Montreal, Quebec, Canada. SIU members represent the full spectrum of clinicians and investigators from all subspecialties that come together to diagnose, treat and support patients with urological disease.
Urocidin is currently undergoing clinical testing in a pivotal Phase III clinical trial. In this trial, patients with non-muscle-invasive bladder cancer whose cancer is specifically refractory (unresponsive) to BCG therapy will receive Urocidin in an open label study. Thirty-one urology centres in North America are participating and enrolment is expected to be completed in the first quarter of calendar 2009.
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. Elderly patients do not seem to respond as well to BCG treatment and are more prone to adverse events.
The refractory to BCG 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.
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
