BELLEVILLE, ON, Sept. 27 /PRNewswire-FirstCall/ - 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.
SOURCE Bioniche Life Sciences Inc.
Copyright . 27 PR Newswire