Israeli company sees promising results in blood cancer treatment trial
The bone marrow transplant graft treatment Omidubicel had already received Breakthrough Therapy Designation from the FDA.
The bone marrow transplant graft treatment Omidubicel had already received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA), and if successful in trials it could be the first treatment of its kind to hold FDA approval.
“The totality of these data strengthen my belief that Omidubicel has the potential to be a graft source for any patient who does not have access to a matched related donor, and could help make stem cell transplantation more accessible and more successful for patients with lethal blood cancers,” said Mitchell Horwitz, M.D., principal investigator and professor of medicine at the Duke Cancer Institute.
The phase III trial was meant to test the safety and effectiveness of the drug in patients with blood cancers undergoing bone marrow transplants, compared with data from patients who underwent standard blood transfusions.
In May, Gamida reported that Omidubicel demonstrated a significant reduction in the amount of time until the patients reach neutrophil engraftment within their treatment, and within phase III, the company reported that most of its patients reach platelet engraftment by day 42.
Other factors of the study included whether or not the patient developed a bacterial infection from the treatment and the survival rate of patients undergoing the treatment – all categories meeting their marks.
“These additional data reinforce the potential of Omidubicel and move us another step closer toward bringing potentially curative therapies to patients. We look forward to presenting data at a future medical meeting, and we are continuing our work to enable the submission of our biologics license application for Omidubicel to the FDA on a rolling basis, both expected in the fourth quarter,” Gamida Cell CEO Dr. Julian Adams said.