Revolutionary Israeli bone marrow transplant method meets trial goals
Following market research, Gamida Cell expects to treat 2,000 patients in the US in the three years after the drug is offered to patients.
Israel-based Gamida Cell Ltd. announced this week that its phase III study of Omidubicel had met all of its primary and secondary goals regarding key clinical measures in bone marrow transplants. The company also announced that it is prepared with a commercial model for Omidubicel that will include a support system for patients and families called Gamida Cell Assist.
The primary goal that was met in the third phase of the trial was estimating the time from transplant of Omidubcel to the reception of neutrophils, a type of blood cell that leads the body’s immune system’s response. The amount of time was 12 days compared to 22 days in the control group.
Additionally, the trial met all of its secondary goals. Of patients treated with the Omidubcels, 37% developed infections that were moderate or severe compared to 57% of the control group in the 100 days following transplant. Omidubcel recipients spent 60.5 days out of the hospital in the 100 days following treatment compared to 48 days in the control group.
Following market research, Gamida Cell expects to treat 2,000 patients in the US in the three years after the drug is offered to patients. This is approximately 20% of patients with no available donor according to Gamida Cell.
“Our goal with Omidubicel is to revolutionize bone marrow transplants and create treatment options for thousands of patients who need bone marrow transplants, for whom a donor is not found,” said Dr. Julien Adams, the CEO of Gamida Cell.
“These results bring us closer to that goal […] It was proved that transplants using Omidubcel create faster reception of neutrophils, and reduce the amount of time patients spend in the hospital and significantly reducing infections. These are very significant results for the patients and may also reduce the total cost of the transplant procedure,” Adams went on to say.