BELLEVILLE, ON, Aug. 16 /PRNewswire-FirstCall/ - Bioniche Life SciencesInc. (TSX: BNC), a research-based, technology-driven Canadianbiopharmaceutical company, is pleased to provide an update on the progress ofits North American clinical trial with Mycobacterial Cell Wall-DNA Complex(MCC) - trademarked Urocidin - in patients with non muscle-invasive bladdercancer that is refractory to the current standard therapy. This indication wasgiven Fast Track designation by the U.S. Food and Drug Administration (FDA) inApril of 2006.
The Company commenced this trial in November, 2006. Since it had beendecided to work with opinion leaders and important medical institutions acrossNorth America, there was some delay before all sites were given the go-aheadto participate by their busy ethical committees and contract negotiators. Aninvestigators' meeting was held in April, 2007, and since then significantprogress has been made in the trial:
Bioniche continues to work with regulators to optimize the design of itssecond registration study in bladder cancer; a trial which will directlycompare the efficacy of Urocidin with the incumbent therapy for nonmuscle-invasive bladder cancer. Progress on finalizing the design andinitiation of this trial will be reported as they are completed.
Bioniche also continues to have discussions with potential development andmarketing partners, but as such discussions are under strict confidentialityprovisions, 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 modeof action: immune stimulation and direct anticancer activity. It is formulatedas Urocidin(TM) for the treatment of bladder cancer, where it is administeredby the intravesical route directly into the bladder, coming into contact withimmune system cells and bladder cancer cells. MCC is also undergoingpreclinical evaluation as a treatment for peritoneal carcinomatosis associatedwith colon and ovarian cancer.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-drivenCanadian biopharmaceutical company focused on the discovery, development,manufacturing, and marketing of proprietary products for human and animalhealth markets worldwide. The fully-integrated company employs approximately185 skilled personnel and has three operating divisions: Human Health, AnimalHealth, and Food Safety. The Company's primary goal is to develop proprietarycancer therapies supported by revenues from marketed products in human andanimal health. For more information, please visit www.Bioniche.com.
Except for historical information, this news release may containforward-looking statements that reflect the Company's current expectationregarding future events. These forward-looking statements involve risk anduncertainties, which may cause, but are not limited to, changing marketconditions, the successful and timely completion of clinical studies, theestablishment of corporate alliances, the impact of competitive products andpricing, new product development, uncertainties related to the regulatoryapproval process, and other risks detailed from time to time in the Company'songoing quarterly and annual reporting.- 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 th