Bioniche Life Sciences Announces Additional Bladder Cancer Results
- Escalating dose results in enhanced response with no significant adverse reactivity -
BELLEVILLE, ON, March 18 /CNW/ - Bioniche Life Sciences Inc. (TSX: BNC), made three important presentations on the company's lead proprietary technology MCC (Mycobacterial Cell Wall DNA Complex) to the delegates of the 18th Congress of the European Urology Association meeting held in Madrid Spain.
Dr. Stephanie Reader, Proteomics Project Leader, Bioniche Therapeutics, presented data showing that MCC treatment of bladder cancer cells results in a significant decrease in the levels of a number of intracellular enzymes that participate in cell cycle progression and cell division. These results are consistent with the observation that MCC causes cell cycle arrest and inhibits the division of cancer cells.
Dr. Nigel Phillips, Chief Scientific Officer, Bioniche Life Sciences Inc. presented data showing that exposure of bladder cancer cells to sub-optimal concentrations of MCC did not result in the generation of resistance to itself or to two other unrelated cancer chemotherapeutic agents, Mitomycin C and Doxorubicin, and did not result in the enhanced expression of proteins associated with multidrug resistance in cancer cells.
"These data provide a pharmacological basis for establishing the mechanism of action of MCC against bladder cancer cells, and indicate that the use of MCC for the treatment of patients with bladder cancer will not result in the generation of resistance to itself or to the development of cross- resistance to other chemotherapeutic agents" said Dr. Phillips.
Dr. Alvaro Morales, Professor of Urology and Oncology at Queen's University, Kingston Ontario presented interim 26 week data on a Phase II clinical trial using MCC at a dose of 8mg. He compared these results with the previously conducted clinical trial where patients were given a series of treatments with MCC at 4mg per dose. The interim 26-week results indicate an enhanced response at 8mg with no observable change in side effect profile. At 26 weeks the 4mg patient population showed a complete response rate of 47.4% per protocol. The patients treated with 8mg showed 68% complete response. Dr. Morales will be presenting additional data at the upcoming Annual Meeting of the American Urological Association to be held in Chicago Illinois in April.
Dr. Morales concluded "Continuing observation provides a strong support for MCC as a safe and effective option for bladder cancer patients failing first line therapy. At an escalated dose, the efficacy of MCC appears to be enhanced without compromising its safety profile. Long term follow-up data are needed to confirm the durability of the response rates documented in the initial study. However, the clinical results to date indicate that MCC is an effective alternative to current treatments for refractory cancer in situ of the bladder."
Bioniche Life Sciences currently markets, in Europe and Canada, Cystistat(R), a proprietary treatment for interstitial cystitis, a severe bladder inflammatory condition. A pivotal clinical trial is being conducted with Cystistat(R) in the USA. With the very satisfactory results with MCC at two dose levels, and a pivotal study planned to commence in the USA and Europe by the end of 2003, Bioniche Life Sciences is positioning itself to become a dominant player in the global urology market.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a leading Canadian biopharmaceutical company that develops, manufactures, and markets proprietary products for human and animal health markets worldwide. The company is developing a pipeline of anti-cancer therapies based on its proprietary mycobacterial cell wall-DNA complex (MCC) technologies. The Company has 235 employees worldwide in four business units: Bioniche Pharma, Bioniche Therapeutics, Bioniche Animal Health, and Bioniche Food Safety. For more information visit www.bioniche.com.
Bioniche Life Sciences Inc. trades on the Toronto Stock Exchange (TSX) under the symbol "BNC" and currently has 27,868,427 shares outstanding.
Except for historical information, this press release may contain forward-looking statements, which 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.