Bioniche Experiences Increased Trading Activity
September 27 2010 - 3:56PM
PR Newswire (Canada)
BELLEVILLE, ON, Sept. 27 /CNW/ -- BELLEVILLE, ON, Sept. 27 /CNW/ -
Bioniche Life Sciences Inc. (TSX: BNC), a research-based,
technology driven Canadian biopharmaceutical company, has noted
substantial share trading volume and share price increase over
recent days. Management believes that this market activity is
driven by expectation of a disclosure concerning its U.S. Food and
Drug Administration (FDA) Phase III Fast Track clinical trial with
Urocidin(TM) a product for non-muscle-invasive bladder cancer that
is refractory to current first-line therapy. Such disclosure is
expected to become available within the next several weeks. This
clinical trial involves the use of an intravesical formulation of a
patented mycobacterial cell wall composition: Mycobacterial Cell
Wall-DNA Complex (MCC), known as Urocidin(TM) (or "EN3348") for
treatment-refractory non-muscle-invasive bladder cancer. The trial
completed recruitment of patients in March, 2009, with the last
patient reaching his/her one-year assessment this spring. Data
compilation has been ongoing since that time, with the Company's
development partner, Endo Pharmaceuticals Inc., conducting detailed
analyses of the data. Such analyses are still ongoing. The
Company's development partner is the party responsible for
oversight of the Urocidin(TM) clinical development program. Status
updates on the program and future plans to further develop
Urocidin(TM) are being defined and will be disclosed by Endo. It
was announced on August 19, 2010 that the parties are finalizing a
protocol for an additional clinical trial - expected to begin
enrolling patients in 2010. About Bladder Cancer 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. Four development milestones have been
achieved by the Company since November, 2009, resulting in total
payments of US$19 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 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 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 211 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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