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 allogeneic hematopoietic stem cell transplant (HSCT) outcomes in patients with hematological cancers or inherited blood disorders who lack a matched donor.

In January, FDA placed the hold after it said three reported cases of encephalopathy were possibly related to the candidate (see BioCentury, Feb. 2)...