Israeli cell therapy company Gamida Cell (Nasdaq: GMDA) today reported positive results from its Phase III clinical study for omidubicel, a potential life-saving treatment for patients in need of bone marrow transplant.
The study found that the median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group. Neutrophil engraftment is a measure of how quickly the stem cells a patient receives in a transplant are established and begin to make healthy new cells, and rapid neutrophil engraftment has been associated with fewer infections and shorter hospitalizations.
Despite the curative potential of bone marrow transplant, it is estimated that more than 40% of eligible patients in the US do not receive a transplant for various reasons, including the lack of a matched donor. Even for patients who do receive a transplant, treatment is not always effective and can lead to serious complications that can dramatically affect their quality of life. Omidubicel addresses the limitations of bone marrow transplant by providing a therapeutic dose of stem cells while preserving the cells’ functional therapeutic characteristics.
Gamida Cell CEO Julian Adams said, "Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the US Food and Drug Administration and has the potential to be the first FDA-approved bone marrow transplant graft. We are very pleased with the results of the Phase III data reported today, which move us one step closer toward bringing potentially curative therapies to patients. We expect to begin to submit our biologics license application for omidubicel to the FDA on a rolling basis in the fourth quarter of this year."
Published by Globes, Israel business news - www.globes-online.com - on May 12, 2020
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