SAN DIEGO, CA--(Marketwired - May 12, 2014) - Regen BioPharma Inc., a majority owned subsidiary of Bio-Matrix Scientific Group Inc. (PINKSHEETS: BMSN), announced today an update on its IND # 15376 for use of HemaXellerate I™ in treatment of patients with drug refractory aplastic anemia.
On March 6, 2014, Regen submitted a protocol modification, additional details on manufacturing, and new data to the FDA regarding therapeutic effects of HemaXellerate I™ in animal models of diseases similar to aplastic anemia in humans, as well as additional safety data.
The Company reports the FDA accepted the clinical protocol and the product manufacturing information provided, however, clarification on animal safety studies was requested.
"Given the HemaXellerate I™ product is derived from the patient's own fat tissue, and numerous key opinion leaders support clinical entry of our product, as demonstrated by our peer reviewed publication http://www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf., we are confident the safety studies the FDA requested clarification on can be addressed in a timely fashion," stated Thomas Ichim, Regen's Chief Scientific Officer and Board Member.
"The role of the FDA is to ensure the highest standards of safety for new products. We view the requested clarifications from the FDA in regards to safety studies as part of the normal process of FDA submission. Given that the HemaXellerate I™ possesses the potential to treat multiple conditions, we view the demonstration of safety as a fundamental step, which will position the Company to expand use of this 'stem cell drug' for multiple other indications," noted David Koos, the Company's Chairman & CEO. "Having passed the clinical trial protocol approval and the manufacturing approval, are major milestones for Regen."
On May 9, 2014 the Company updated its IND with changes requested by the FDA and submitted them for review.
About Regen BioPharma: Regen BioPharma, Inc., a majority owned subsidiary of Bio-Matrix Scientific Group, Inc. (PINKSHEETS: BMSN), is a biotechnology company focused on identifying undervalued regenerative medicine applications in the stem cell space and rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials. Currently the Company is focused on developing treatments for Aplastic Anemia and a gene silencing therapy for treating cancer. For more information refer to the company's website http://www.regenbiopharma.com/
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