Additional Phase III clinical trial with Urocidin(TM) expected to commence in 2010
August 19 2010 - 7:00AM
PR Newswire (Canada)
BELLEVILLE, ON, Aug. 19 /CNW/ -- - analysis of data from first
Phase III clinical trial nearing completion - BELLEVILLE, ON, Aug.
19 /CNW/ - Bioniche Life Sciences Inc. (TSX: BNC), a
research-based, technology driven Canadian biopharmaceutical
company, today provided an update on the clinical development
program for its proprietary product for non-muscle-invasive bladder
cancer - Urocidin(TM). Bioniche and its development partner, Endo
Pharmaceuticals Inc. (NASDAQ: ENDP), are in the process of
finalizing a protocol for an additional clinical trial - expected
to begin enrolling patients in 2010. Details of this new protocol,
when finalized, will be made publicly available via the U.S.
National Institutes of Health clinical trial registration service
at http://www.clinicaltrials.gov. "We're preparing to initiate a
large study with Urocidin in the second half of this year that
could become the pivotal study of this very interesting product to
treat bladder cancer," said Dr. Ivan Gergel, Executive Vice
President, Research and Development at Endo Pharmaceuticals Inc.
"Urocidin is a novel treatment for refractory bladder cancer, which
represents the type of innovative solutions we want to offer
urologists and their patients." Concurrently, 12-month data from
the ongoing U.S. Food and Drug Administration (FDA) Phase III
registration trial with Urocidin(TM) for non-muscle-invasive
bladder cancer refractory to current therapy are undergoing
thorough analysis. Endo expects to complete this process by the end
of September, 2010. In North America, bladder cancer is the fourth
most common cancer in men and is in the top ten for women. In the
United States, approximately 70,000 patients are newly diagnosed
with bladder cancer each year and 500,000 living patients have been
affected. The cancers of many of the previously-diagnosed patients
remain unresolved, sometimes leading to cystectomy (bladder
removal) or death. Approximately 70 percent of bladder cancer
patients have the non-muscle-invasive form of bladder cancer and,
on appropriate regulatory approvals, might be eligible for multiple
treatments with Urocidin(TM). Non-muscle-invasive bladder cancer is
a form of bladder cancer localized in the surface layers of the
bladder that has not yet spread into the deeper muscle layer. This
form of bladder cancer is treated predominantly by urologists using
surgical resection and intravesical infusion therapy. Urocidin(TM)
is an intravesical infusion therapy, administered via
trans-urethral catheter into the bladder. Under the licensing
agreement, Bioniche received an up-front payment of US$20 million
in July, 2009, and has the potential to receive a total of US$110
million in payments associated with the achievement of certain
clinical, regulatory and commercial milestones. Three milestones
have been achieved by the Company since November, 2009, for total
proceeds of US$14 million. Future milestones will be announced as
they are achieved and, with its exclusive manufacturing supply
contract, Bioniche will also receive a net-sales-based revenue
stream upon product approval. About Urocidin(TM) Urocidin(TM) is a
formulation of MCC, a sterile mycobacterial cell wall-DNA complex
composition that has a dual mode of action: immune stimulation and
direct anticancer activity. Urocidin(TM) is formulated for the
treatment of bladder cancer, where it is administered by
trans-urethral catheter directly into the bladder, coming into
contact with immune system cells and bladder cancer cells. Industry
Canada's Industrial Technologies Office (formerly Technology
Partnerships Canada) has contributed to the development of
Bioniche's mycobacterial cell wall technologies by means of a C$9.6
million loan to be repaid from sales. 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. 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. %SEDAR: 00013159EF Jennifer Shea, Vice-President,
Communications, Investor & Government Relations, Bioniche Life
Sciences Inc., Telephone: (613) 966-8058, Cell: (613) 391-2097,
Jennifer.Shea@Bioniche.com
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