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Prostate Cancer
OncoGenex Achieves Key Regulatory Milestone for Lead Product Candidate, OGX-011
October 28th, 2008
OncoGenex Pharmaceuticals Inc. (NASDAQ:OGXI) announced that it concluded a meeting with the U.S. Food and Drug Administration (FDA) on October 7, 2008, and that the FDA agreed that "durable pain palliation is an acceptable and desirable study endpoint" to support a product marketing approval for OGX-011 as a treatment for hormone refractory prostate cancer (HRPC). In addition, OncoGenex reported that the FDA provided guidance on the submitted protocol including recommendations on study endpoints, the appropriate patient population, entry criteria and study conduct. The company plans to revise and submit the protocol for completing a Special Protocol Assessment with the FDA prior to...
Source: Cancer Weekly (2008-10-28)
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