Regen BioPharma Files IND Application With FDA On HemaXellerate I

By RTT News, February 05, 2013, 10:59:00 AM EDT

(RTTNews.com) - Regen BioPharma, a wholly-owned subsidiary of Bio-Matrix Scientific Group Inc. (BMSN.PK), on Tuesday announced filing of an Investigational New Drug application with the FDA to initiate clinical trials assessing the company's HemaXellerate I stem cell drug in patients with drug-refractory aplastic anemia.

HemaXellerate I is a patient-specific composition of cells that have previously been demonstrated to repair damaged bone marrow and stimulate production of blood cells based on previous animal studies.

If the clinical trial is successful, the company plans to expand use of HemaXellerate I to other conditions associated with bone marrow dysfunction, with the overall goal of entering the hematopoietic growth factor market, which is substantial in size and currently includes drugs such as Neupogen, Neulasta, Leukine and Revolade.

The planned clinical trial anticipates recruiting 10 patients who have failed standard of care, which will be treated with HemaXellerate I and followed for safety parameters and signals of efficacy. Therapeutic effects will be quantified based on immunological measurements, as well as improvement in blood counts. Patients in the trial will be assessed for one year, however, because the trial is unblinded, data will be available as the study progresses.

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Regen BioPharma Files IND Application With FDA On HemaXellerate I