February 24, 2016 8:31am

 

During the meeting, the FDA indicated general agreement with Asterias' proposed development plan for registration of AST-VAC1 through a single P3 trial to support an accelerated development pathway and Biologics License Application (BLA) filing - BUY


 

Asterias Biotherapeutics, Inc. (NYSE:AST) today announced the successful completion of an End-of-Phase 2 meeting with the U.S. FDA for AST-VAC1, its investigational therapy targeting acute myeloid leukemia (AML).

 

In this study, Asterias will assess the impact of AST-VAC1 compared to placebo on the duration of relapse-free-survival as the primary endpoint, and on overall survival as the secondary endpoint in patients who have achieved complete remission using standard therapies.

The proposed trial will include AML patients 60 years and older, along with younger individuals who are at high risk for relapse and are not candidates for allogeneic bone marrow transplantation.

Pending positive results, this trial could be the basis for accelerated approval of AST-VAC1. Asterias currently plans to submit a request for a Special Protocol Assessment (SPA) to the FDA to confirm the primary endpoint and other design elements of this pivotal Phase 3 trial.

 

 

The Bottom Line: The FDA “indicated general agreement” on AST’s proposal for registration of AST-VAC1 through single P3 trial to support an accelerated development pathway, BLA filing …

·         Study to assess AST-VAC1 vs placebo on duration of relapse- free-survival as primary endpoint, overall survival as secondary endpoint in patients who have achieved complete remission using standard therapies

·         Plans to submit request for SPA to confirm primary endpoint and trial design

 

AST closed at $3.50 which was DOWN -$0.20 on small volume – 27.45 K <3 month average = 78.8 K shares> - BUY, any positive news is appreciative.