Bellicum planning changes to end clinical hold

Bellicum Pharmaceuticals Inc. (NASDAQ:BLCM) said FDA has outlined criteria required to lift the agency's clinical hold on U.S. trials of adjunct T cell therapy BPX-501. The treatment, which consists of genetically modified donor cells and contains the company's CaspaCIDe safety switch, is in Phase I and Phase I/II testing to improve outcomes after stem cell transplants.

In January, FDA placed the hold after it said three reported cases of encephalopathy were possibly related to the candidate (see BioCentury Extra, Jan. 31). ...