OncoGenex Pharmaceuticals is a biopharmaceutical company committed to the development and commercialization of new cancer therapies that address unmet needs in the treatment of cancer. We have a deep oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development.
We currently have four product candidates in development: OGX-011, OGX-427, CSP-9222 and OGX-225. Three of the products are in clinical development.
We have conducted five phase 2 clinical trials to evaluate the ability of OGX-011 to enhance the effects of therapy in prostate, non-small cell lung and breast cancer.
In December 2009, we announced that we entered into a Collaboration and License Agreement with Teva Pharmaceutical Industries, for the development and global commercialization of OGX-011. In connection with the Collaboration Agreement, OncoGenex and Teva developed a Clinical Development Plan under which the following three phase 3 clinical trials will be initiated:
- a phase 3 clinical trial of OGX-011 in approximately 300 patients with second-line castrate resistant prostate cancer;
- a phase 3 clinical trial of OGX-011 in approximately 800 patients with first-line castrate resistant prostate cancer; and
- a phase 3 clinical trial of OGX-011 in at least 700 patients with first-line non-small cell lung cancer.
We have reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of two Phase 3 registration trials of OGX-011 in patients ith CRPC via the Special Protocol Assessment (SPA) process.