OncoGenex commences enrollment in OGX-427 Phase II trial for bladder cancer

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) 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.