FDA Grants Fast Track Designation for OncoGenex Pharmaceuticals' Lead Product Candidate OGX-011
OncoGenex Pharmaceuticals 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.
"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.
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