SAN DIEGO, CA -- (Marketwired) -- 04/04/13 -- Regen BioPharma, Inc. (Regen), a wholly-owned subsidiary of Bio-Matrix Scientific Group, Inc. (OTCQB: BMSN), provided an update on the Company's progress with HemaXellerate and other new developments.
Currently, Regen is focused on two core areas: a)The HemaXellerate Program, which is based on treating disorders of blood production; and b) Our cancer immunotherapy Program which leverages specific cells called "dendritic cells" to specifically kill cancer but not healthy tissue.
In June 2012 the Company acquired an option to license US patent # 6,821,513 covering use of endothelial cells to stimulate blood cell production. Subsequently Regen has filed patent applications # 61/648898 and # 61/670791 covering stimulation of blood cell production using placental and fat derived cells, respectively.
Utilizing these technologies, as well as, results obtained from studies performed at the Torrey Pines Institute for Molecular Medicine by Sophia Khaldoyanidi, M.D., Ph.D., Regen has developed the HemaXellerate product, which is a patient-specific composition of cells that has previously been demonstrated to repair damaged bone marrow and stimulate production of blood cells.
Together with opinion leaders from University of Utah, Indiana University, and Cook General Biotechnology, Regen has published a peer-reviewed paper describing preclinical data supporting the use of HemaXellerate http://www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf. This paper was widely received by the scientific community and was granted "Highly Accessed" status by the Journal of Translational Medicine.
On February 5th, 2013 Regen filed an Investigational New Drug (IND) application with the FDA to initiate clinical trials using HemaXellerate for treatment of patients with aplastic anemia that are resistant to current therapies. The FDA issued IND # 15376 to Regen in response to the Company's IND application. The Company has been in communication with the FDA, which informed us that, as per FDA procedure, a letter outlining items which must be addressed prior to initiating clinical trials will be sent to us shortly. Regen is confident the Company will be able to address these items to the FDA's satisfaction. It is the goal of the Company to initiate clinical trials by Q4 of 2013. Additionally, aplastic anemia is considered an Orphan Disease and we plan to apply for Orphan Drug Status during clinical development.
Proof of concept in the proposed 10 patient aplastic anemia trial will allow us to expand into the larger market of blood production disorders which exceeds $4.84 billion per year and currently addressed by growth factors such as Neupogen®, Neulasta®, Leukine® and Revolade®. (www.wikinvest.com/stock/Amgen). The clinical trial is anticipated to take 12-18 months until completion and the Principle Investigator is Dr. Michael Murphy from Indiana University who previously published with us. Regen plans to execute a licensing/co-development agreement once proof of concept in patients has been obtained.
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