Dendreon (DNDN) Said FDA Amends SPA on IMPACT clinical trial of PROVENGE

March 12, 2008 7:42 AM EDT

Dendreon Corporation (Nasdaq: DNDN) said the FDA has agreed to an amended Special Protocol Assessment for the Phase 3 IMPACT clinical trial of PROVENGE.

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 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.

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