The U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for AlloVir’s posoleucel (Viralym-M, ALVR105) to treat adenovirus (AdV) infection following allogeneic hematopoietic stem cell transplant (allo-HCT). AdV can be a potentially life-threatening viral infection, with a range of symptoms in allo-HCT patients including gastroenteric or respiratory symptoms, pneumonia, hepatitis, severe hemorrhagic enteritis or cystitis, or multi-organ failure. Posoleucel is currently in the late-stage clinical development as an allogeneic, off-the-shelf, multi-virus specific T-cell therapy that is designed to target six viral pathogens in immunocompromised patients, including: adenovirus, BK virus, cytomegalovirus, Epstein-Barr virus, human herpes virus-6, and JC virus. Currently, there is no approved treatment for AdV in allo-HCT patients. The FDA designation, RMAT, is reserved for therapeutic tissue engineered products (TEP), cell therapies, and human cell or tissue products that have the potential to save patients from life-threatening or incurable diseases and conditions. AlloVir is a late clinical stage cell therapy company that develops products to restore natural immunity against life-threatening viral diseases in both pediatric and adult patients with might weakened immune systems.
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