AlloVir’s Posoleucel Receives the US FDA’s RMAT Designation for Prevention of Multiple Infections from 6 Viruses in Patient with Allogeneic Hematopoietic Cell Transplant
Shots:
- The US FDA has granted RMAT designation to posoleucel for the prevention of inf. from 6 devastating viruses in high-risk adult & pediatric patients with allo-HCT
- The designation was based on a P-II study evaluating posoleucel in patients with allo-HCT. The results showed that 26 patients received 1 dose of posoleucel including those who completed, discontinued, or continued posoleucel while 3 clinical inf. were observed @14wk.
- Additionally, 21 out of 24 patients remained free of inf. & were well-tolerated. The final results are expected at end of 2022. Posoleucel is an allogeneic, off-the-shelf, multi-virus specific T cell therapy & is currently being studied in 3 P-III trials for three indications
Ref: Businesswire | Image: Globe Newswire
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