Bluebird Bio Doubts Its Gene Therapy Caused Leukemia in Phase 1/2 Trial

Bluebird bio said its investigations have shown that it’s “very unlikely” that LentiGlobin, the company’s investigational gene therapy for sickle cell disease, caused the case of acute myeloid leukemia (AML) reported recently during LentiGlobin’s phase 1/2 trial.

The suspected serious adverse reaction resulted in the FDA instructing the company to halt its trial in late February.

Given the results of its analysis in addition to findings from independent analyses, the company says it’s talking with regulators to begin the process of resuming clinical studies on LentiGlobin for sickle cell disease.

Bluebird is continuing to investigate a possible second adverse reaction of what appears to be myelodysplastic syndrome in a study participant.