Healthcare Industry News: bladder cancer
News Release - August 16, 2007
Bioniche Provides Update on Refractory Bladder Cancer TrialTrial underway since November, 2006
BELLEVILLE, ON, Aug. 16 (HSMN NewsFeed) - Bioniche Life Sciences Inc. (TSX: BNC ), a research-based, technology-driven Canadian biopharmaceutical company, is pleased to provide an update on the progress of its North American clinical trial with Mycobacterial Cell Wall-DNA Complex (MCC) - trademarked Urocidin - in patients with non muscle-invasive bladder cancer that is refractory to the current standard therapy. 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. Since it had been decided to work with opinion leaders and important medical institutions across North America, there was some delay before all sites were given the go-ahead to participate by their busy ethical committees and contract negotiators. An investigators' meeting was held in April, 2007, and since then significant progress has been made in the trial:
-The full complement of 25 sites has now been fully qualified to enroll patients and Bioniche's clinical team expects that the trial will be fully enrolled towards the end of calendar 2007. The targeted enrollment of this study is 105 patients which, coupled with additional safety information collected from a comparative trial, will allow full results to be reported 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.
-On August 15, 2007 the first meeting of the Data Safety Monitoring Committee was held. 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 meeting of the Committee will be held in six months.
Bioniche continues to work with regulators to optimize the design of its second registration study in bladder cancer; a trial which will directly compare the efficacy of Urocidin with the incumbent therapy for non muscle-invasive bladder cancer. Progress on finalizing the design and initiation of this trial will be reported as they are completed.
Bioniche also continues to have discussions with potential development and marketing partners, but as such discussions are under strict confidentiality provisions, Bioniche is not in a position to provide an update at this time.
MCC is a sterile mycobacterial cell wall 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 the intravesical route directly into the bladder, coming into contact with immune system cells and bladder cancer cells. MCC is also 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 185 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. 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.
Source: Bioniche Life Sciences
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