Investors in Houston-based Bellicum $BLCM can now breathe a sigh of relief.
The company reported Wednesday evening that the FDA has lifted the clinical hold it dropped on their studies of BPX-501 after amending their trial protocols. The company did not reveal exactly what it had to do, but Bellicum performed in line with expectations in keeping the halt to a relatively brief spell.
In a newly released statement, the biotech noted:
The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring and management of neurologic adverse events. Bellicum will be working with U.S. clinical sites to resume patient recruitment based on the amended protocols.
The biotech’s stock immediately jumped about 17% in a post-market rally.
Investigators rattled investors at the end of January with news that their cell therapy — pitched as a safer alternative to currently marketed pioneers — had been linked with brain damage in patients. The regulatory action did not have an impact on Bellicum’s registrational study of BPX-501 in Europe, dubbed BP-004.
About a month ago the company reported that among 38 pediatric AML patients treated with BPX-501 following haploidentical hematopoietic stem cell transplant, researchers tracked a median relapse-free rate of 91.5% and overall survival of 97.3% during a one-year followup in their BP-004 study in Europe. There’s no control group to compare against, but the biotech pointed to historical rates of 60% to 80% following alternate-donor HSCT.
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