bluebird bio says AML case pmlive.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pmlive.com Daily Mail and Mail on Sunday newspapers.
Dive Brief:
Executives at Bluebird bio on Thursday gave investors listening to a conference hosted by bank SVB Leerink an update on their investigation into two recent cancer cases in a study of the company s gene therapy for sickle cell disease.
The two diagnoses are a serious safety concern, recalling past worries over the potential for gene therapy to trigger genetic mutations that might lead to cancer. In response, Bluebird halted further study of the experimental gene therapy, and suspended sales of a similar product approved in Europe for the blood disease beta thalassemia.
New information shared by Bluebird s CEO and chief scientific officer, however, suggest other factors than the gene therapy may have led to one of cases, a diagnosis of acute myeloid leukemia in a patient treated five years ago. And the other case, of myelodysplastic syndrome in a more recently treated trial volunteer, may not be a conclusive diagnosis, the executives said.
FDA Places Clinical Hold on Sickle Cell Gene Therapy medscape.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medscape.com Daily Mail and Mail on Sunday newspapers.
Dive Brief:
Bluebird bio has stopped two clinical studies of its gene therapy for sickle cell disease after one participant developed leukemia and researchers reported another has a cancer-like disease of the bone marrow.
A patient treated five years ago as part of the first group enrolled in a Phase 1/2 study of Bluebird s study was recently diagnosed with acute myeloid leukemia, Bluebird said Tuesday. Another study participant, who was enrolled in a later group of that trial, is reported to have developed myledoysplastic syndrome, the second such case to occur in testing of the gene therapy since 2018. Bluebird is investigating to determine the cause.
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