- results from this trial supported entry into Company's current Phase
III bladder cancer program -
BELLEVILLE, ON, Feb. 18 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that The Journal of Urology has published an article summarizing the Phase II clinical trial results for the Company's proprietary Mycobacterial Cell Wall technology in bladder cancer.
The article, entitled "Intravesical Mycobacterial Cell Wall-DNA Complex in the Treatment of Carcinoma In Situ of the Bladder After Standard Intravesical Therapy has Failed", was co-authored by Drs. Alvaro Morales (Queen's University - Kingston, Ontario, Canada), Kiran Phadke (St.-George Hospital, Kogarah, New South Wales, Australia), and Gary Steinhoff (Vancouver Island Health Authority - Victoria, British Columbia, Canada). The Phase II trial resulted in a complete response rate in the intent-to-treat population of 27.3% at weeks 12 and 26 at a 4 mg dose and a 46.4% response at the same two points in patients receiving an 8 mg dose. Complete response was defined as no evidence of disease as determined by cystoscopy, biopsy and cytology. The product was well tolerated by both dose groups, with 90% of all adverse events being mild to moderate in severity.
"We concluded that Mycobacterial Cell Wall-DNA Complex has shown antineoplastic (anticancer) activity in patients with bladder cancer with less toxicity than that associated with bacillus Calmette-Guerin (BCG) administration," said Dr. Alvaro Morales, Director of the Centre for Advanced Urological Research and Professor in the Department of Urology, Queen's University, Kingston, Ontario, Canada. "Safety concerns exist with BCG because it is a live mycobacterium and its use is associated with a number of local and systemic side effects, as well as the potential for proliferation and systemic dissemination."<
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