-Amended Agreement Accelerates Expected Timing of Final Analysis by One Year While Maintaining Comparable Powering of Interim and Final Results- -Dendreon to Hold Conference Call on Thursday, March 13, 2008 at 11:00 AM
SEATTLE, March 12 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) has agreed to an amended Special Protocol Assessment (SPA) for the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE(R) (sipuleucel-T), the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. In addition, the FDA has reconfirmed that they would accept a positive interim or final analysis from the IMPACT trial to amend the Biologics License Application (BLA) for licensure of PROVENGE.
The amended SPA accelerates the expected timing of the final IMPACT results by approximately one year while maintaining comparable powering of the study's interim and final results. By increasing the number of events and decreasing the alpha (false positive error) spending function for the interim analysis, the Company is able to reduce the number of events for the final analysis (from 360 to 304) and still maintain a comparable statistical power for both the interim and final analyses. Interim results are still expected in the second half of 2008; however, final results are now expected in the second half of 2009 rather than 2010.
Based on the statistical plan in the amended SPA, if the treatment
effect at the interim analysis for the IMPACT trial is consistent with the
integrated results of the previous two completed pha
|SOURCE Dendreon Corporation|
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