OncoGenex Pharmaceuticals, Inc. (OGXI) recently announced that it has finished enrolling patients in its phase II study, Borealis-1, which is being conducted to evaluate the survival benefit, safety and tolerability of OGX-427 plus Eli Lilly & Company’s (LLY) Gemzar and Platinol for the treatment of patients with advanced bladder cancer.
The randomized, placebo-controlled phase II study has enrolled roughly 180 patients who will be randomized to receive Gemzar, Platinol, and OGX-427 at two dose-levels (600 mg or 1000 mg) or Gemzar, Platinol and placebo.
While overall survival is the primary endpoint of the study, benefit/risk of the two dosages will be also evaluated using clinical benefit, safety and tolerability outcomes for each dose.
Data from the Borealis-1 study is expected in the second half of 2014.
Another study that is being conducted on OGX-427 for metastatic bladder cancer is Borealis-2. The Borealis-2 study is being conducted in patients suffering from advanced or metastatic bladder cancer whose disease has progressed following initial platinum-based chemotherapy treatment.
OncoGenex’ OGX-427 is in seven phase II studies, namely, Borealis-1, Borealis-2, Pacific, Spruce, OGX-427-PR01, Rainier and Cedar.
The Pacific study is evaluating the benefit of OGX-427 plus Zytiga in patients with castrate-resistant prostate cancer (CRPC). Patient enrollment is currently in progress. The Spruce study is being conducted for the treatment of previously untreated advanced non-squamous non-small cell lung cancer patients.
Rainieris designed to evaluate the survival benefit of adding OGX-427 to Celgene Corp.’s (CELG) Abraxane plus Gemzar in previously untreated metastatic pancreatic cancer patients.
The Cedar study is evaluating OGX-427 as a first-line therapy in patients suffering from advanced squamous cell lung cancer.
OncoGenex carries a Zacks Rank #3 (Hold). Currently, Jazz Pharmaceuticals (JAZZ) looks moreattractive with a Zacks Rank #1 (Strong Buy).
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