- Second Phase III clinical trial to begin later this year -
BELLEVILLE, ON, March 4 /CNW/ - Bioniche Life Sciences Inc. (TSX: BNC), a
research-based, technology-driven Canadian biopharmaceutical company, today
announced that it has received notice from the U.S. Food and Drug
Administration (FDA) that its therapy for first-line non-muscle-invasive
bladder cancer meets the criteria for Fast Track designation. A Phase III
clinical trial comparing a formulation of the Company's Mycobacterial Cell
Wall-DNA Complex (MCC) - Urocidin(TM) - to the current standard therapy in
patients with non-muscle-invasive bladder cancer at high risk of recurrence or
progression. This clinical trial, scheduled to begin later in 2008, aims to
demonstrate non-inferior efficacy with respect to disease-free survival and
fewer toxicities than the current therapy.
This is the second Phase III trial of the Company to receive Fast Track
designation: Bioniche's registration trial of Urocidin for bladder cancer
patients that have failed current therapies was designated as Fast Track in
April, 2006. That first "Refractory" Phase III trial is ongoing at leading
bladder cancer centres across Canada and the United States.
The designation of a product/indication as Fast Tracked means that the
FDA will take such actions as are appropriate to expedite the development and
review of the application for approval of such product. The FDA may also
evaluate for filing and commence review of portions of an application for
approval of a Fast Track product under certain conditions. The potential for
expedited review and the ability to file submission documents on a rolling
basis can serve to accelerate final product approval. In its letter of notice,
the FDA indicated, "We look forward to working with you to expedite the
development and review of this promising proposed use of the product."
"This is an important milestone for our Phase III clinical development
program with Urocidin," said Graeme McRae, President & CEO of Bioniche Life
Sciences Inc. "It highlights the need for a safer and more effective therapy
for first-line bladder cancer patients. The FDA clearly recognizes that the
current approved therapy is less than satisfactory, and wishes to expedite the
introduction of new therapies."
In September, 2007, the Company announced that an agreement had been
reached with the FDA under the Special Protocol Assessment (SPA) procedure for
this Phase III trial of Urocidin as a first-line therapy. An SPA provides
assurance that, if the proposed endpoints are met, they will serve as the
basis for approval of the product as part of a Biologics Licensing Application
(BLA). An SPA gives a clear pathway to registration of the product when the
study endpoints are achieved.
Bioniche plans to begin recruitment of patients for this second pivotal
study later this year. The study currently plans to enrol approximately 800
patients in North America, Australia and Europe and is a double-blind,
randomized study. It will compare MCC to the standard treatment for non
muscle-invasive bladder cancer at high risk of recurrence or progression -
Bacillus Calmette-Guérin (BCG). BCG is a live, attenuated strain of
Mycobacterium bovis and is often associated with treatment-limiting side
effects including active bacterial infections.
The Company also continues to enroll patients in its first Fast Track
Phase III clinical trial with Urocidin. When fully enrolled, this trial will
involve 105 patients in North America with non muscle-invasive bladder cancer
that is refractory to BCG. The Company reported last month that the Data
Safety Monitoring Committee held its third scheduled quarterly meeting
regarding this clinical trial, after which it recommended that Bioniche
"continue the trial unmodified until the next scheduled or triggered meeting."
The next meeting of the Committee will be held in May, 2008.
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
200 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. Bioniche has been named one of Canada's Top Ten Life Sciences
Companies for 2008. 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.
For further information:
For further information: Jennifer Shea, Corporate Communications,
Investor & Government Relations Director, Bioniche Life Sciences Inc.,
Telephone: (613) 966-8058, Cell: (613) 391-2097, Jennifer.Shea@Bioniche.com