BLCM - FDA puts clinical hold on Bellicum's cancer therapy

Bellicum Pharmaceuticals (BLCM) slides 12% in premarket as the FDA has placed a clinical hold on enrollment and dosing in Phase 1/2 study evaluating BPX-601, a GoCAR-T candidate, in patients with previously treated metastatic pancreatic or prostate cancer, after the death of a patient.The company said the death was unrelated to the treatment, BPX-601, but that it would work with the FDA to resume the trial.The company also said the clinical hold does not affect the company’s plans to initiate enrollment in Phase 1/2 trial of BPX-603, a dual switch GoCAR-T, in patients with HER2+ solid tumors by the end of this year.In October, it announced restructuring program, wherein it will focus on the clinical development of BPX-601 and BPX-603, and staff will be reduced by 79%, from 68 to 14 employees by the end of this year.

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FDA puts clinical hold on Bellicum's cancer therapy