H.I.G. Capital News
OncoGenex Pharmaceuticals Initiates an International, Randomized, Phase II Clinical Trial Evaluating OGX-427 in Advanced Bladder Cancer
Company continues focus on addressing treatment resistance to standard therapies in difficult-to-treat cancers
BOTHELL, WASHINGTON & VANCOUVER, BRITISH COLUMBIA - October 20, 2011 - OncoGenex Pharmaceuticals, Inc. announced today that it has initiated patient enrollment in a randomized, Phase II clinical trial evaluating OGX-427, an inhibitor of heat shock protein 27 (Hsp27), in patients with advanced bladder cancer. The trial is designed to assess the potential survival benefit of combining OGX-427 with standard first-line chemotherapy, as well as its safety, tolerability and optimal dosing regimen. Hsp27, which is over-expressed in many cancers, helps tumor cells survive by resisting the effects of anti-cancer treatments, such as chemotherapy and radiation therapy.
"Advanced bladder cancer is often a difficult-to-treat malignancy with very few therapeutic options currently available," said Dr. Bernhard J. Eigl, MD, Assistant Professor at the University of Calgary and a principal investigator on the study. "We are eager to identify and validate novel therapies, such as OGX-427, that address treatment resistance and expand our armamentarium of anti-cancer agents."
OGX-427 has been evaluated in a Phase I trial in patients with breast, prostate, bladder, ovarian and non-small cell lung cancer who previously failed potentially curative treatments, or for whom a curative treatment did not exist. Results of this Phase I trial, presented at the 2010 American Society of Clinical Oncology annual meeting, demonstrated anti-cancer activity, safety, and tolerability with OGX-427 as a single agent and in combination with chemotherapy.
This international Phase II trial is a double-blind, placebo-controlled, 3-arm, randomized trial that will enroll approximately 180 patients with advanced bladder cancer who have not previously received chemotherapy for metastatic disease and are not candidates for potentially curative surgery or radiotherapy. Patients will be randomized to receive gemcitabine, cisplatin, and OGX-427 at two dose-levels (600 mg and 1000 mg) vs. gemcitabine, cisplatin, and placebo. The study will be conducted at approximately 45 cancer centers throughout North America and Europe.
"The OGX-427 development program, specifically this new trial in advanced bladder cancer, reinforces OncoGenex' mission to advance therapies that address treatment resistance," said Scott Cormack, President and CEO of OncoGenex. "As demonstrated with the previous custirsen, or OGX-011, Phase II development program, this trial initiation reflects OncoGenex' core competencies, which are to identify molecular targets that contribute to cancer progression, establish robust development plans, and execute well-designed trials that provide a clear path towards bringing novel treatments to patients with difficult-to-treat cancers."
In addition to this company-sponsored, advanced bladder cancer trial, OGX-427 is currently being studied in an investigator-sponsored, Phase I trial of patients with superficial bladder cancer and an investigator-sponsored, randomized, Phase II trial of men with castrate-resistant prostate cancer who have not received chemotherapy for metastatic disease. Preliminary data from these two trials are expected to be presented in early 2012.
More information is available at www.OncoGenex.com or http://clinicaltrials.gov/ct2/show/NCT01454089?term=NCT01454089&rank=1
About Bladder Cancer
Bladder cancer is the 5th most common cancer overall. In the United States alone in 2011, approximately 69,250 people will be diagnosed with bladder cancer, and 14,990 will die from the disease.
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new cancer therapies that address treatment resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development.OncoGenexandTeva Pharmaceutical Industries Ltd.(NASDAQ:TEVA) have entered a global collaboration and license agreement to develop and commercialize OncoGenex' lead drug candidate, custirsen. Custirsen is currently in Phase III clinical development as a treatment in men with metastatic castrate-resistant prostate cancer. The companies plan to begin Phase III development of custirsen in first-line treatment of advanced, unresectable non-small cell lung cancer. OGX-427 is in Phase II clinical development; CSP-9222 and OGX-225 are currently in pre-clinical development.
More information is available atwww.OncoGenex.com.
OncoGenex' Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning our anticipated product development activities, such as expected clinical trial initiation, interim publication of results and completion dates, patient enrollment targets, the timing and costs of our product development activities and the potential benefits of our product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk of delays in our expected clinical trials and the presentation of clinical data and the uncertainties regarding patient enrollment rates, the risk that new developments in the rapidly evolving cancer therapy landscape require additional changes in our clinical trial design or limit the potential benefits of our product and the other factors described in our risk factors set forth in our filings with theSecurities and Exchange Commissionfrom time to time, including the Company's Quarterly Report on Form 10-Q for second quarter endedJune 30, 2011. The Company undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.
SOURCE OncoGenex Pharmaceuticals, Inc.