SOURCE: Bio-Matrix Scientific Group, Inc.
SAN DIEGO, CA–(Marketwired – Jul 31, 2013) – Bio-Matrix Scientific Group Inc. (OTCQB: BMSN) provided an update today on its subsidiary, Regen BioPharma’s Investigational New Drug (IND) application (#15376) with the U. S. Food and Drug Administration (FDA) covering the HemaXellerate I stem cell product for treatment of drug refractory aplastic anemia.
“We are currently in the second round of discussions with the FDA.On May 20, 2013, we filed our answers to comments the FDA made regarding the trial design and preclinical data.On June 21, 2013, we received a second set of FDA comments stating several of their questions were adequately addressed, however additional data needs to be submitted,” said David Koos, Chairman and CEO of Bio-Matrix Scientific Group (Regen’s parent company).”The back and forth process with the FDA is part of standard procedure associated with new drug applications.The Company is extremely appreciative of the input it has received from the FDA and looks forward to addressing their concerns within the next several months.”
Regen BioPharma has assembled a team of key opinion leaders in the area of adipose stem cells, which have previously reported the scientific basis for HemaXellerate in a peer-reviewed publication http://www.translational-medicine.com/content...10-231.pdf . The company is currently working with these key opinion leaders to address the FDA’s comments.
A Company spokesperson noted:
1.Regen has already filed one non-provisional patent application and is preparing to file two more based on research conducted in support of Its IND application.
2.The clinical trial proposed in our IND is based on using a drug product derived from the same patient, for stimulating production of new blood cells in aplastic anemia patients for which other treatments have failed.
3.Demonstrating proof of concept in this patient population will not only provide a potential Orphan Drug designation, but also will allow entry into other conditions associated with failure of the bone marrow to produce blood.This market is substantial in size and currently is addressed by biological drugs such as Neupogen, Neulasta, Leukine and Revolade.
4.The Company has recently been informed that a patent has expired on which a license agreement was entered into and disclosed on June 6, 2012.As a result of the expiration of this patent, the Company believes that it shall no longer be bound to make certain license payments to the licensor.After extensive review, the Company does not believe this event will negatively impact the probability of the It being granted patent protection on improvements included in its own patent applications related to HemaXellerate.
