Regen BioPharma, a wholly owned subsidiary of San Diego-based Bio-Matrix Scientific Group Inc. (PNK: BMSN), announced Tuesday the filing of an Investigational New Drug application with the Food and Drug Administration 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.
This market is substantial in size and currently includes drugs such as Neupogen, Neulasta, Leukine and Revolade.
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