UROCIDIN™ PHASE III CLINICAL TRIAL RESULTS PRESENTED AT AUA CONFERENCE IN WASHINGTON, D.C.
May 17 2011 - 4:00PM
PR Newswire (Canada)
CHADDS FORD, PA, and BELLEVILLE, ON, May 17 /CNW/ -- -podium
presentation by Dr. Alvaro Morales, Global Principal Investigator-
CHADDS FORD, PA, and BELLEVILLE, ON, May 17 /CNW/ - Endo
Pharmaceuticals and Bioniche Life Sciences today presented Phase
III trial results for the intravesical formulation of Mycobacterial
cell wall-DNA complex (MCC), known as Urocidin™, during a podium
presentation at the 2011 American Urological Association annual
meeting in Washington, D.C. The preliminary results from the
interim analysis of this prospective trial indicate that
Urocidin(TM) may provide an alternative to cystectomy for patients
with bacillus Calmette-Guérin (BCG) refractory non-muscle invasive
bladder cancer (NMIBC). The preliminary results were generated from
an interim analysis in an ongoing Phase III trial with Urocidin in
the treatment of NMIBC that is refractory to BCG and at high risk
of progression. The Results A total of 129 patients were enrolled
from 25 centers in the U.S. and Canada, with high grade papillary
tumors and/or carcinoma in situ (CIS) and having failed to respond
to one or more courses of BCG. According to the preliminary results
the overall one-year disease-free survival (DFS) rate was 25
percent. DFS is defined as lack of recurrence or progression to
muscle-invasive disease, as confirmed by biopsy. The one-year DFS
rate was 35 percent for patients with only papillary tumors and 21
percent for patients with carcinoma in situ (CIS) with or without
papillary tumors. The preliminary results indicate that
intravesical administration of Urocidin™ was well tolerated.
Ongoing Phase III Clinical Program with Urocidin(TM) Summary
details of a Phase III clinical trial protocol with Urocidin™ being
conducted by Endo are publicly available via the U.S. National
Institutes of Health (NIH) clinical trial registration service at
http://www.clinicaltrials.gov. This trial is actively enrolling
eligible NMIBC patients. About Bladder Cancer In North America,
bladder cancer is the fourth most common cancer in men and the
fifth overall between both men and 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. In
Europe, more than 100,000 patients are newly diagnosed each year.
Bladder cancer is frequently a recurrent disease, with some cases
becoming refractory to available chemotherapeutic or
immunotherapeutic agents and leading to cystectomy (bladder
removal) or death. Approximately 70 percent of bladder cancer
patients have the non-muscle invasive form of bladder cancer.
Collectively across the U.S., Europe and Japan, approximately
350,000 non-muscle invasive bladder cancer patients are newly
diagnosed or have a recurrence each year. 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. About
Urocidin(TM ) Urocidin(TM) is a formulation of MCC, a sterile
mycobacterial cell wall-DNA complex composition that appears to
have a dual mode of action: immune stimulation and direct
anticancer activity. Urocidin(TM) is being investigated for the
treatment of non-muscle invasive bladder cancer, where it is
administered by trans-urethral catheter directly into the bladder.
The agent is then able to directly interact with the cells of the
immune system 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 by Bioniche from sales. About the
Endo-Bioniche Partnership Endo holds exclusive global rights to
develop and market Bioniche's patented formulation of Mycobacterial
Cell Wall-DNA Complex (MCC), Urocidin™, being developed for the
intravesical treatment of non-muscle invasive bladder cancer. Under
the licensing agreement, Bioniche received an up-front payment of
US$20 million in July 2009, and became eligible to receive an
additional US$110 million in milestone payments. Milestones are
announced as they are achieved and, with its exclusive
manufacturing supply contract, Bioniche provides clinical trial
material and will also receive a net-sales-based revenue stream
upon product approval. 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 more than 200 skilled personnel and has three operating
divisions: Human Health, Animal Health, and Food Safety. For more
information, please visit Bioniche.com. About Endo Pharmaceuticals
Inc. Endo Pharmaceuticals is a U.S.-based, specialty healthcare
solutions company, focused on high-value branded products and
specialty generics. Endo is redefining its position in the
healthcare marketplace by anticipating and embracing the evolution
of health decisions based on the need for high-quality and
cost-effective care. We aim to be the premier partner to healthcare
professionals and payment providers, delivering an innovative suite
of complementary diagnostics, drugs, devices and clinical data to
meet the needs of patients in areas such as pain, urology, oncology
and endocrinology. For more information about Endo Pharmaceuticals,
and its wholly owned subsidiaries HealthTronics, Inc. and Qualitest
Pharmaceuticals, please visit endo.com. Bioniche Forward-Looking
Statements 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. Endo
Forward-Looking Statements This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Statements including
words such as "believes," "expects," "anticipates," "intends,"
"estimates," "plan," "will," "may," "look forward," "intend,"
"guidance," "future" or similar expressions are forward-looking
statements. Because these statements reflect our current views,
expectations and beliefs concerning future events, these
forward-looking statements involve risks and uncertainties.
Investors should note that many factors, as more fully described
under the caption "Risk Factors" in our Form 10-K, Form 10-Q and
Form 8-K filings with the Securities and Exchange Commission and as
otherwise enumerated herein or therein, could affect our future
financial results and could cause our actual results to differ
materially from those expressed in forward-looking statements
contained in our Annual Report on Form 10-K. The forward-looking
statements in this press release are qualified by these risk
factors. These are factors that, individually or in the aggregate,
could cause our actual results to differ materially from expected
and historical results. We assume no obligation to publicly update
any forward-looking statements, whether as a result of new
information, future developments or otherwise. To view this news
release in HTML formatting, please use the following URL:
http://www.newswire.ca/en/releases/archive/May2011/17/c5395.html
table valign="top" border="0" tr td ubEndo:/b/ubr/
Investors br/ Jonathan
Neely br/ (610)
459-6645 /td td br/ Mediabr/ Kevin
Wigginsbr/ (610) 459-7281 /td /tr tr td
ubBioniche/b/ub: /bbr/
Jennifer Sheabr/ Telephone: (613) 966-8058; from Australia: 0011 1
613-966-8058br/ Cell: (613) 391-2097; from Australia: 0011 1
613-391-2097 /td td br/ br/ /td /tr /table
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