Pfizer Resumes Dosing In Phase 3 Hemophilia Gene Therapy Trial 6 Months After FDA Lifts Hold

 

• Pfizer Inc 
  PFE
   and its partner Sangamo Therapeutics Inc 
  SGMO-1.79%+ Free Alerts
   have reopened enrollment in phase 3 AFFINE study hemophilia A gene therapy trial. 
• Trial sites will begin to resume enrollment this month, with dosing expected to restart in October.
• The study will evaluate the efficacy and safety of a single infusion of giroctocogene fitelparvovec in more than 60 adult male participants with moderately severe to severe hemophilia A. 
• The primary endpoint is the impact on annualized bleeding rate (ABR) through 15 months following the treatment.
• The FDA put the study of giroctocogene fitelparvovec on hold in November 2021. Pfizer hit pause after seeing some patients experience blood clotting protein factor VIII activity greater than 150%. 
• In March this year, the FDA lifted the clinical hold, but Pfizer kept the voluntary pause in place while working to meet "all necessary conditions," including approval of updated trial protocols by regulatory authorities. 
• In May, Sangamo said the trial would start in Q3 of 2022, with data expected in 2H of 2023. The target for the data drop is further delayed to the first half of 2024. 

https://www.benzinga.com/general/biotech/22/09/28986729/pfizer-resumes-dosing-in-phase-3-hemophilia-gene-therapy-trial-six-months-after-fda-lifts-clinica