BELLEVILLE, ON, May 12 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. , a research-based, technology-driven Canadian biopharmaceutical company, is pleased to provide an update on the clinical and non-clinical development of its proprietary platform technology: Mycobacterial Cell Wall-DNA Complex (MCC).
Phase III Clinical Program in Bladder Cancer
More than two-thirds of the 105 patients required for the Company’s first Phase III clinical trial with MCC (trademarked Urocidin) have now been enrolled. The Company expects patient enrolment to be completed in the second half of calendar 2008. The North American trial involves 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.
The Data Safety Monitoring Committee held its fourth scheduled meeting regarding this clinical trial on May 8, 2008. 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 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.
A number of additional investigational sites have been added to the trial. These are: Towson, Maryland; Dallas, Texas; Poughkeepsie, New York; Evansville, Indiana; Pittsburgh, Pennsylvania; La Mesa, California; and Garden City, New York. “We are pleased to have an additional seven clinical sites and investigators participating in our first Phase III clinical trial with MCC,” said Dr. Francois Charette, Chief Medical Officer at Bioniche Life Sciences Inc. “With a total of 32 sites participating, we expect that the speed of enrolment will increase and our goal of full enrolment before year-end will be achieved.”
The data collected from this 105-patient trial, when coupled with additional safety information collected from a second trial, will allow full results to be reported approximately one year after recruitment is completed for the efficacy and safety datasets. These results may also support regulatory submissions under 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 25th site validated in September, 2007. The trial has been progressing throughout this time.
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 in February of this year.
Bioniche plans to begin recruitment of patients for the second pivotal trial later this year. The trial will enrol approximately 800 patients and is a double-blind, randomized trial.
Bioniche Life Sciences Inc. was among the presenters at the 4th Canadian Conference on Ovarian Cancer Research held in Montreal, Quebec last week. Two presentations on MCC were made to the delegates attending the event:
The results of the first study demonstrate that MCC has antiproliferative and apoptosis-inducing activity against a range of human ovarian cancer cell lines, and that this activity is independent of several drug resistance mechanisms common to ovarian malignancy. The second study demonstrates that MCC has anticancer activity in vivo in a model of peritoneal carcinomatosis, thus confirming its potential for cancers that have the potential to metastasize to this anatomical site.
Bioniche has previously demonstrated that MCC has anticancer activity in an animal model of peritoneal carcinomatosis (colon cancer) and the data from the present studies confirm that MCC has the potential for development as a therapeutic treatment for a range of cancers that are known to affect the peritoneal cavity. These include colon, stomach, appendix, biliary, pancreatic and breast cancer, as well as cases of mesothelioma, in which a significant proportion of patients have peritoneal cavity involvement.
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, Corporate Communications, Investor & Government
Relations Director, Bioniche Life Sciences Inc., Telephone: (613) 966-8058,
Cell: (613) 391-2097, Jennifer.Shea@Bioniche.com
