Recruitment Reopened for Phase 3 AFFINE Gene Therapy Trial
This trial is evaluating the efficacy and safety of a single infusion of an investigational gene therapy in individuals with moderately severe to severe hemophilia A.
Pfizer and Sangamo have announced that recruitment has re-opened for the phase 3 AFFINE study for the investigational gene therapy giroctocogene fitelparvovec. This clinical study is evaluating the efficacy and safety of a single infusion of giroctocogene fitelparvovec in more than 60 adult (ages 18-64 years) participants with moderately severe to severe hemophilia A.
A primary focus for trial investigators will be the therapy’s impact on annualized bleeding rate (ABR) through 15 months following treatment. The ABR reached through a single administration of giroctocogene fitelparvovec will be compared to the ABR achieved through six months of prior prophylaxis using a factor VIII replacement therapy.
A new press release laid out a general timeline with participant enrollment to begin this month, patient dosing to “expected to resume” in October, all clinical trial sites to be active ay the end of 2022, and a public release of topline results in the first half of 2024.
Source: Pfizer press release dated September 22, 2022