Pfizer suspends clinical trials of gene therapy for hemophilia due to increased risk of blood clots
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Pfizer suspends clinical trials of gene therapy for hemophilia due to increased risk of blood clots.
The latest news shows that although the U.S. FDA has canceled the phase III Affine clinical study of hemophilia A gene therapy giroctocogene fitelparvovec in March this year.
Pfizer and its partner Sangamo Therapeutics voluntarily suspended after discovering that the therapy may increase the risk of blood clots.
R&D trials were initiated and treatment regimens started to be adjusted.
It is reported that Pfizer recently discovered a deep vein thrombosis below the knee in a trial participant with high factor VIII levels.
The patient has a history of thrombosis and is currently doing well. Pfizer is also analyzing the factors for this thrombosis.
The first-quarter financial report released recently shows that Pfizer has stopped related trials and is considering resuming clinical research and development within a few months.
The company expects clinical trials to resume in the third quarter of this year and expects to announce relevant trial results in the second half of 2023.
According to public information, hemophilia A is a hereditary disease caused by the deficiency or dysfunction of coagulation factor VIII. The normal level of coagulation factor VIII in the human body is between 50% and 150%.
Previously, Pfizer’s hemophilia gene therapy development was delayed due to a clinical hold by the U.S. Food and Drug Administration, putting it behind rivals CSL Behring and BioMarin, both of which are reported to intend to submit applications for regulatory approval by mid-year.
However, Pfizer’s other investigational therapies also have clinical potential to treat hemophilia, and data from several related trials are expected to be released in 2023.
Marstacimab is a novel non-factor therapy candidate that has previously received Fast Track designation from the US FDA for the treatment of hemophilia A and B.
In addition, Pfizer also said last week that the U.S. Food and Drug Administration (FDA) has allowed a Phase 3 clinical trial of its Duchenne muscular dystrophy (DMD) gene therapy fordadistrogene Movaparvovec to continue.
The therapy was reportedly put on hold by the FDA late last year after a patient died.
Reference:
Another Pfizer gene therapy is free of FDA hold, but delay continues
Pfizer suspends clinical trials of gene therapy for hemophilia due to increased risk of blood clots
(source:internet, reference only)
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