Regen BioPharma Files Investigational New Drug (IND) Application With FDA on HemaXellerate I Stem Cell Drug for Aplastic Anemia
Published: Feb 05, 2013
SAN DIEGO, CA--(Marketwire - February 05, 2013) - Regen BioPharma a wholly-owned subsidiary of Bio-Matrix Scientific Group Inc. (PINKSHEETS: BMSN), announced today filing of an Investigational New Drug (IND) 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. 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. (PINKSHEETS: BMSN) is a biotechnology company developing regenerative medicine therapies. The Company is focused on human therapies that address unmet medical needs. Specifically, Bio-Matrix Scientific Group Inc. is looking to increase the quality of life through therapies involving stem cell treatments. These treatments are focused in areas relating to cardiovascular, hematology, oncology and other indications.
Regen BioPharma, Inc., a subsidiary of Bio-Matrix Scientific Group, Inc. (PINKSHEETS: BMSN), is a biotechnology company focused on identifying undervalued regenerative medicine patents in the stem cell space and rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials. To follow our development, visit us at www.regenbiopharma.com.
This news release may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks
Bio-Matrix Scientific Group, Inc.
David R. Koos, PhD
Chairman & Chief Executive Officer