BELLEVILLE, Ontario, April 3 /PRNewswire-FirstCall/ -- Bioniche Life Sciences Inc. , a research-based, technology-driven Canadian biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has given approval to proceed with the second of two Phase III clinical trials using the Company’s proprietary Mycobacterial Cell Wall-DNA Complex (MCC) for the treatment of bladder cancer, trademarked Urocidin. It was announced on February 7th that the protocol for the first trial had been approved.
The second Phase III trial will involve approximately 630 patients in a randomized, double-blind multi-centre trial comparing Urocidin to Bacillus Calmette-Guerin (BCG) as first-line therapy in non-muscle invasive (superficial) bladder cancer at high risk of recurrence or progression. BCG is a live, attenuated strain of Mycobacterium bovis that is the current standard therapy for bladder cancer, but is a treatment that is often associated with treatment-limiting side effects. The Bioniche study will be conducted in North America and Europe.
The first Phase III trial will be carried out at the same time as the second. It will involve 105 patients in an open-label study showing the efficacy of Urocidin as therapy in non-muscle invasive bladder cancer that is refractory (unresponsive) to BCG. This study will be conducted in North America.
Patient enrollment for both trials is expected to commence by mid-2006.
“We expect a 40% minimum complete response rate in the refractory study,” said Graeme McRae, President & CEO of Bioniche Life Sciences Inc. “Complete response means no evidence of disease after cystoscopy, cytology, and biopsy. The compelling results in our Phase I/II studies in this patient population give us assurance that we will achieve this level of response. In the comparative study, we expect to show non-inferiority to BCG, which currently demonstrates a 60 - 70% response rate. In addition, we expect to show improved safety over BCG.”
“The activity of MCC has been demonstrated against bladder cancer in the Phase I/II trials,” said Dr. Alvaro Morales, Professor of Urology and Oncology at Queen’s University in Kingston, Ontario, and International Principal Investigator for the Bioniche Phase III program. “My own experience suggests very strongly that the safety profile of MCC is much better than BCG and, certainly, MCC is easier to handle, from the pharmacist’s, nurse’s and physician’s points of view due to the risk of acquiring a serious infection from improper handling of BCG which is a live bacteria as opposed to MCC that contains only bacterial cell wall fragments and DNA. Biohazard precautions are required for BCG but not for MCC, which is also a significant plus for the latter.”
Approximately 142,000 patients in North America and Europe are newly- diagnosed with non-muscle invasive bladder cancer each year. Approximately 96,000 of these are high-risk cases, of which 30%+/- are refractory (non- responsive) to standard therapy (BCG).
“The incidence and the death rate per year are not startling for bladder cancer,” said Dr. Harry Herr, Urologist at Memorial Sloan Kettering Cancer Center and the North American Principal Investigator in the Bioniche Phase III bladder cancer program, “but because it’s so prevalent -- meaning it recurs -- probably the most prevalent disease second to skin cancer in man. It’s estimated that there are about 500,000 to 600,000 ‘walking worried’ individuals in the United States alone who are undergoing surveillance for recurrent bladder cancer. Although per year, the number of bladder cancer cases is low, the total scope of the problem as a public health problem is enormous. Bladder cancer is a lifelong disease despite treatment.”
“This is a significant milestone in the history of our Company,” added Graeme McRae. “A large investment and many years of research have been involved in bringing this technology to this point. We all look forward to the successful outcome of the Phase III trials so that we may proceed with our commercialization strategy.” Bioniche is contemplating a marketing partnership with a view to achieving rapid market uptake upon approval of Urocidin.
About Urocidin (MCC)
Mycobacterial Cell Wall-DNA Complex (MCC) is formulated from Mycobacterium phlei, a non-pathogenic strain of mycobacteria. MCC has been shown to have immune stimulatory and apoptosis (programmed cell death) activity against cancer cells. The product is a sterile biological composition in a sub-micron suspension. Urocidin is produced at the Bioniche manufacturing facility in Pointe-Claire, Quebec.
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 181 skilled personnel and has three principal 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. For more information, please visit http://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.
For further information, please contact: Jennifer Shea, Corporate Communications Manager Bioniche Life Sciences Inc. Tel: 613-966-8058 ext. 1250 / Cell: 613- 391-2097 Jennifer.Shea@Bioniche.com Rachel Levine, Investor Relations The Global Consulting Group Tel: 646-284-9439 Rlevine@hfgcg.com
Bioniche Life Sciences Inc.
CONTACT: Jennifer Shea, Corporate Communications Manager, Bioniche LifeSciences Inc., +1-613-966-8058 ext. 1250 or Cell: +1-613-391-2097,Jennifer.Shea@Bioniche.com; Rachel Levine, Investor Relations, The GlobalConsulting Group, +1-646-284-9439, Rlevine@hfgcg.com, for Bioniche LifeSciences Inc.
Web site: http://www.Bioniche.com/
