SAN DIEGO, CA--(Marketwire - Feb 5, 2013) - Regen BioPharma a wholly-owned subsidiary of Bio-Matrix Scientific Group Inc. (
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. The company, together with an internationally-renowned group of stem cell researchers, recently published the scientific basis for the HemaXellerate I™ product which may be found at http://www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf.
"Currently patients with aplastic anemia who are resistant to drugs and ineligible for bone marrow transplant have no therapeutic options. We are fortunate to be in the position to have developed a novel approach to potentially treat this terrible condition," said David Koos, CEO of Bio-Matrix. "To our knowledge the HemaXellerate I™ product is the only therapy that has potential to simultaneously block the underlying cause of aplastic anemia while at the same time rebuilding the bone marrow tissue that has been damaged by the disease."
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®.
"Current drug-based approaches for healing bone marrow damage involve "flooding" the body with growth factors, which is extremely expensive and causes unintended consequences because of lack of selectivity," said Dr. Vladimir Bogin, CEO of Chromos Pharma (a contract research organization), which collaborated with Regen on filing the IND and member of the Company's Scientific Advisory Board. "Based on our data HemaXellerate I™ possesses the advantage delivering an optimized cellular mixture that produces the needed growth factors at the specific location in the bone marrow niche."
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.
About Bio-Matrix Scientific Group Inc. and Regen BioPharma, Inc.:
Bio-Matrix Scientific Group, Inc. (
Regen BioPharma, Inc., a subsidiary of Bio-Matrix Scientific Group, Inc. (
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