Bellicum Pharmaceuticals (NASDAQ: BLCM) of Houston divulged Wednesday that its lead T-cell therapy program BPX-501 has been put on hold by the FDA. The treatment, for certain people undergoing bone marrow transplant, uses two components: off-the-shelf T cells to replace those killed in the transplant process, and a pill that acts as a “kill switch” if the new T cells are rejected and cause graft-versus-host disease.
The trial has been paused because of three cases of unspecified brain injuries. Bellicum described the cases as “complex” with “a number of potentially confounding factors.” It’s not clear when U.S. studies will resume. A European trial has not been halted, the company said. Bellicum stock was down nearly 30 percent, to $5.78 a share, in midday trading.
Photo by Amit Patel via Creative Commons 2.0 license.