Urocidin Phase III Clinical Trial Results Presented at AUA Conference in Washington, D.C.
-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 UrocidinTM 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.
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 UrocidinTM
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. UrocidinTM is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.
UrocidinTM 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. UrocidinTM 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<http://www.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<http://www.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.
For further information: Endo: Investors Jonathan Neely (610) 459-6645 Media Kevin Wiggins (610) 459-7281 Bioniche: Jennifer Shea Telephone: (613) 966-8058; from Australia: 0011 1 613-966-8058 Cell: (613) 391-2097; from Australia: 0011 1 613-391-2097
Posted: May 2011