- this second pivotal study targeted to commence in Q1, calendar 2008 -
- conference call/audio webcast on Wednesday, September 12, 2007 at
9:30 a.m. ET to discuss -
BELLEVILLE, ON, Sept. 10 /CNW/ - Bioniche Life Sciences Inc. (TSX: BNC),
a research-based, technology-driven Canadian biopharmaceutical company, today
announced that an agreement has been reached with the U.S. Food and Drug
Administration (FDA) under the Special Protocol Assessment (SPA) procedure.
This SPA agreement relates to the Company's pivotal Phase III study using its
proprietary Mycobacterial Cell Wall-DNA Complex (MCC) in non muscle-invasive
bladder cancer at high risk of recurrence or progression.
"This is a major milestone for the Company," said Cindy Benning,
Vice-President of Operations, Quality and Regulatory Affairs of Bioniche Life
Sciences Inc. "It indicates agreement by the FDA on the design of the study,
including its endpoints, data analysis and conduct. It provides assurance
that, if the trial endpoints are met, they will serve as the basis for product
approval under a Biologics Licensing Application (BLA). A SPA gives a clear
pathway to registration of Urocidin(TM) when the study endpoints are
"This second pivotal trial will provide first-line bladder cancer
patients with access to Urocidin," stated Dr. Francois Charette, Chief Medical
Officer of Bioniche Life Sciences Inc. "With our ongoing pivotal trial in
treatment-refractory bladder cancer, this study will add further insight into
the efficacy and safety of Urocidin."
"Our regulatory and clinical teams have worked closely with the FDA's
Centre for Biologics Evaluation and Research (CBER) to ensure that we have a
well-controlled and adequately designed study to clearly demonstrate the
efficacy and safety of our product," said Mr. Graeme McRae, President & CEO of
Bioniche Life Sciences Inc.
Bioniche plans to begin recruitment of patients for the second pivotal
study in Q1, calendar 2008. The study will 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
The primary efficacy endpoint will be the duration of disease-free
survival of patients after two years. In addition, safety will be evaluated
based on two criteria: the percentage of patients who experience two
consecutive delays of one week in treatment administration due to drug-related
adverse events; and through a comparative tabulation of drug-related adverse
events. The goal will be to demonstrate non-inferior efficacy and improved
safety of Urocidin over BCG.
Dr. Alvaro Morales, Professor of Urology and Oncology at Queen's
University in Kingston, Ontario is the International Principal Investigator
for this Urocidin pivotal trial. He previously served as the Principal
Investigator in the Company's Phase I/II bladder cancer study with this
technology. Dr. Morales is well-known in the North American and International
urology communities, having served on numerous boards and committees,
including the Research Committee of the American Urological
Association/American Foundation for Urologic Disease, which he joined in 1987.
Dr. Morales is widely credited with the introduction of BCG as the current
standard of care in high-risk bladder cancer. Dr. Harry Herr, from Memorial
Sloan-Kettering Cancer Center in New York is the North American Principal
The Company continues to enrol patients in its first Phase III clinical
trial, an open-label study showing the efficacy of MCC as therapy in
superficial bladder cancer refractory (unresponsive) to BCG. This first
pivotal trial was granted fast-track status by the FDA in May, 2006. The
target enrolment of this study is 105 patients and the Bioniche clinical team
expects the trial to be fully enrolled towards the end of calendar 2007. The
trial's Data Safety Monitoring Committee held its first meeting in mid-August,
at which time it reviewed the data generated to date and recommended that the
trial continue unmodified.
"We are pleased with the progress we are making on this refractory
study," added Dr. Charette. "We have 25 North American sites involved and all
are actively screening patients. Urologists are also looking forward to the
beginning of our large comparative trial and have expressed a high interest in
Conference Call & Audio Webcast
For more information about the SPA agreement and its significance for the
Company, please join senior management for a conference call and audio webcast
on Wednesday, September 12, 2007 at 9:30 a.m. ET.
To participate in the conference call, please phone (416) 644-3423 or
A listen-only audio webcast will be available at the following locations:
or through the link on the home page of the Bioniche website
A replay of the conference call will be available until September 19,
2007 by calling (416) 640-1917 or toll-free 1-877-289-8525 (passcode: 21246325
followed by the number sign).
The web cast will be available for replay using the above links until
December 12, 2007
About Mycobacterial Cell Wall-DNA Complex (MCC)
MCC is a sterile mycobacterial cell wall and DNA 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 catheter 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 Bladder Cancer
Approximately 321,000 individuals worldwide are newly-diagnosed with
urothelial bladder cancer each year. Approximately 233,000 of these bladder
cancers are non muscle-invasive (superficial), 70% (+/-) of which are
considered high-grade tumors. This type of bladder cancer is treated by a
combination of surgery (to remove papillary tumors) and intravesicular drug or
BCG therapy (to treat non-operable carcinoma in situ and to prevent recurrence
of papillary tumors). Intravesical therapy of bladder cancer is conventionally
carried out using an induction phase (typically once weekly for 6 weeks)
following surgery, then using a maintenance phase of therapy.
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
195 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.
For further information:
For further information: Jennifer Shea, Manager of Corporate
Communications & Investor Relations, Bioniche Life Sciences Inc., Telephone:
(613) 966-8058 ext. 1250, Cell: (613) 391-2097