FDA grants regenerative medicine advanced therapy designation to AlloVir’s posoleucel
pharmafile | January 6, 2022 | News story | Business Services |
The FDA has granted AlloVir’s posoleucel Regenerative Medicine Advanced Therapy Designation (RMAT), for the treatment of adenovirus infections in adults and children following allogeneic hematopoeietic stem cell transplantation.
The FDA’s designation is based on positive results from the Phase II CHARMS study. A Phase III registrational study (NCT05179057) of poseleucel for the treatment of adenovirus in the bloodstream is now open and enrolling pediatric and adult patients following and allo-HCT.
“We are pleased that the FDA has granted posoleucel RMAT designation for a second treatment-related indication,” said Ercem Atillasoy, MD, Chief Regulatory and Safety Officer, AlloVir. “The two RMAT designations reinforce the potential of posoleucel in areas of urgent patient need. We look forward to working closely with FDA as we continue to advance posoleucel through late-stage clinical development.”
RMAT is a designation made specifically to provide tissue engineered products, cell therapies, human cell and tissue products, or any combination product, that may save patients from serious or life-threatening conditions, or diseases, which would otherwise be incurable. The designation recognises the potential for posoleucel to address the unmet medical need posed by AdV, a potentially life-threatening condition with no approved treatment options.
“The initiation of these posoleucel and ALVR106 studies represents important progress in our effort to bring forward much needed treatment options for immunocompromised patients,” said Richard Riese, MD, PhD, Senior Vice President, Clinical Research, AlloVir. “These investigational multi-VST therapies aim to restore immunity against viruses that, if left untreated, can have devastating consequences. We look forward to working with study investigators to enroll these studies and demonstrate the potential for VST therapy in areas of urgent unmet need.”
Ana Ovey
