New cancer drug nearing the end of clinical trials, so the FDA has move this up to prioritize the evaluation process for the new potential cancer drug to treat prostate, lung and breast cancer. It is being developed to work with other therapies with focus on cancerous tumors. BD
BOTHELL, WA and VANCOUVER, Aug 22, 2008 /PRNewswire-FirstCall via COMTEX/ -- OncoGenex Pharmaceuticals (OGXI: oncogenex pharmaceuticals in com News, chart, profile, more Last: 6.40-1.50-18.99% 3:59pm 08/25/2008 Delayed quote data Add to portfolio Analyst Create alert Insider Discuss Financials Sponsored by: OGXI 6.40, -1.50, -19.0%) announced today 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.