Bioniche Life Sciences Inc. Release: Updates On MCC Phase III Bladder Cancer Study And E. coli O157:H7 Cattle Vaccine Regulatory Progress
BELLEVILLE, Ontario, March 23 /PRNewswire-FirstCall/ -- Bioniche Life Sciences Inc. , a research-based, technology-driven Canadian biopharmaceutical company, today announced that it has received Canadian regulatory approval to proceed with part one of its Phase III bladder cancer program in Canada and also confirmed that its E. coli O157:H7 cattle vaccine is proceeding through the regulatory pathway in the U.S.
Phase III Bladder Cancer Program Regulatory Update
The Biologics and Genetic Therapies Directorate of Health Canada has approved Bioniche's Clinical Trial Application for the first of two Phase III clinical trials using the Company's proprietary Mycobacterial Cell Wall-DNA Complex (MCC) for the treatment of bladder cancer. This follows the Company's announcement of a similar approval by the U.S. Food and Drug Administration (FDA) in February of this year.
Approximately 142,000 patients in North America and Europe are newly-diagnosed with superficial bladder cancer each year. Approximately 96,000 of these are high-risk cases, of which 30%+/- are refractory to standard therapy.
In this first part of the Phase III program, 105 patients will be involved in an open-label study showing the efficacy of MCC as therapy in superficial bladder cancer refractory (unresponsive) to Bacillus Calmette-Guerin (BCG). BCG is a live, attenuated strain of Mycobacterium bovis, the current standard therapy for bladder cancer, but one that is often associated with treatment-limiting side effects. This Bioniche study will be conducted in North America. Patient enrolment will commence in the second quarter of calendar 2006. The FDA is currently reviewing the IND for the second part of the Company's Phase III program, a randomized, double-blind, multi-centre study comparing MCC to BCG as first-line therapy in superficial bladder cancer at high risk of recurrence or progression. This study will take place in both North America and Europe.
E. coli O157:H7 Cattle Vaccine Regulatory Update
The U.S. Department of Agriculture (USDA) has been reviewing a data package submitted by Bioniche that outlines results of research studies using its proprietary E. coli O157:H7 cattle vaccine. The USDA has indicated that the supplied data is not sufficient to support a product registration. Bioniche intends to respond to the USDA by submitting additional study data that it believes will be supportive of the U.S. license for the vaccine.
In the Company's second quarter report, it was noted that the vaccine could be registered in the U.S. later this year, with a milestone target of Q2 to Q3, calendar 2006. Given the additional review by the USDA, this target may have to be adjusted.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company that discovers, develops, manufactures, and markets proprietary products for human and animal health markets worldwide. The fully-integrated Company employs more than 175 individuals and has three principal operating divisions: Animal Health, Food Safety, and Human Health (Bioniche Therapeutics). 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 expectations regarding future events. These forward-looking statements involve risks 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.
For further information, please contact: Jennifer Shea, Corporate Communications Manager, Bioniche Life Sciences Inc. Tel: 613-966-8058 ext. 1250 Jennifer.Shea@Bioniche.com Rachel Levine, Investor Relations, The Global Consulting Group Tel: 646-284-9439 Rlevine@hfgcg.comBioniche Life Sciences Inc.
CONTACT: Jennifer Shea, Corporate Communications Manager, Bioniche LifeSciences Inc., +1-613-966-8058 ext. 1250, or Jennifer.Shea@Bioniche.com ;or Rachel Levine, Investor Relations, The Global Consulting Group forBioniche Life Sciences Inc., +1-646-284-9439, or Rlevine@hfgcg.com
Web site: http://www.bioniche.com//