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# Fast Track Granted for Sangamo Hemophilia Gene Therapy
- URL: https://www.fdaweb.com/fast-track-granted-for-sangamo-hemophilia-gene-therapy/
- Published: 2017-05-16T12:00:00.000Z
- Updated: 2026-09-14T22:23:50.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5138699

FDA has granted Sangamo Therapeutics a fast track designation for SB-525, a clinical stage complementary-DNA (cDNA) gene therapy candidate for hemophilia A, which is being developed as part of a collaboration and license agreement with Pfizer. SB-525 uses a recombinant adeno-associated virus to deliver a human Factor VIII cDNA construct and proprietary, synthetic liver-specific promoter to the nucleus of liver cells with a single infusion, the company says. The therapy is designed as a single treatment strategy intended to provide continuous, therapeutic expression of Factor VIII protein, it adds. FDA has approved an IND for the therapy, and a Phase 1/2 clinical trial evaluating it in adults with hemophilia A is expected to open and begin screening subjects for enrollment by the end of the second quarter.