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FDA clears Pfizer's DMD gene therapy phase 3 clinical trial is about to restart

 Last Update: 2022-05-14
 Source: Internet
 Author: User

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Today, Pfizer announced that the U.

DMD is a rare genetic disorder caused by mutations in the gene encoding dystrophin on the X chromosome

Fordadistrogene movaparvovec, developed by Pfizer, is an investigational intravenous gene therapy

Previously published Phase 1b clinical trial results showed that after 12 months of treatment, patients showed durable and statistically significant improvements, including sustained levels of micro-dystrophin expression (using liquid chromatography mass spectrometry and immunofluorescence staining).

"Duchenne muscular dystrophy is a serious disease with very limited treatment options, and we believe gene therapy has the potential to significantly alter the course of the

References:

[1] Pfizer to Open First US Sites in Phase 3 Trial of Investigational Gene Therapy for Ambulatory Patients with Duchenne Muscular Dystrophy.

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