FDA confirms appropriateness of durable pain palliation as a primary
endpoint for product marketing approval
Milestone achievement results in release of escrowed shares
BOTHELL, WA and VANCOUVER, Oct. 13 /PRNewswire-FirstCall/ - OncoGenex Pharmaceuticals Inc. (NASDAQ: OGXI) today 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 initiating the registration trial.
Based on the results of this meeting, the Board of Directors of OncoGenex Pharmaceuticals has approved the release of 25% (347,207) of the shares held in escrow pursuant to agreements related to Sonus Pharmaceuticals' merger with OncoGenex Technologies described in its Proxy Statement filed with the SEC on July 3, 2008. The escrow agreements provided for the release of 25% of the shares held in escrow following the occurrence of a meeting with the FDA to confirm that pain palliation is an appropriate primary endpoint to support a product marketing approval in prostate cancer. A total of 694,431 milestone shares remain in escrow.
"Our data combining OGX-011 with second line chemotherapy in patients
with HRPC has shown potential improve
|SOURCE OncoGenex Pharmaceuticals, Inc.|
Copyright©2008 PR Newswire.
All rights reserved