OncoGenex Pharmaceuticals' OGX-011 granted FDA fast track status

OncoGenex Pharmaceuticals has announced that OGX-011, also known as custirsen sodium, received Fast Track designation from the U.S. Food & Drug Administration (FDA) in combination with docetaxel for progressive metastatic prostate cancer.

OGX-011 is currently completing five Phase 2 clinical studies in prostate, lung and breast cancer, and is designed to inhibit the production of a specific protein, clusterin, associated with treatment resistance.

Fast Track designation is granted to products that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease. Based on this designation, the FDA will take actions as appropriate to expedite the development and review of OGX-011 for approval. These actions include scheduled meetings to obtain FDA input into development plans, the option of submitting a New Drug Application in sections rather than all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints.

"Obtaining Fast Track designation for custirsen sodium while developing our Phase 3 program for hormone-refractory prostate cancer (HRPC) and in advance of initiating our Phase 3 study is very important and should help us move forward expeditiously on our pathway toward commercialization," said Scott Cormack, chief executive officer of OncoGenex Pharmaceuticals. "We welcome this designation as another example of our ability to rapidly advance our development programs."

The request for Fast Track designation was based on data from Phase 2 studies in HRPC as well as supporting data in non-small cell lung cancer (NSCLC) indicating that OGX-011 treatment can significantly reduce serum clusterin levels and that achieving low serum clusterin levels during treatment is correlated with improved survival. Furthermore, serum clusterin levels during OGX-011 treatment may be predictive of a treatment benefit with OGX-011. In patients with HRPC who had failed first-line docetaxel while on or within six months of first-line docetaxel therapy and received second-line chemotherapy in combination with OGX-011 (Study OGX-011-07), achieving or maintaining low serum clusterin levels correlated with improved survival. Similar results were seen in Study OGX-011-05 in patients with NSCLC who were treated with gemcitabine plus a platinum regimen and OGX-011. Data from the Phase 2 study in HRPC were presented at the 2008 Annual Meeting of the American Society of Clinical Oncology.