Regen BioPharma Submits Experimental Protocol to F
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Posted On: 10/06/2014 3:12:43 PM
Regen BioPharma Submits Experimental Protocol to FDA for HemaXellerate Aplastic Anemia Trial
Ongoing Dialogue With FDA Aimed at Initiating Clinical Trial for IND # 15376
SAN DIEGO, CA--(Marketwired - Oct 6, 2014) - Regen BioPharma Inc. (OTCBB: RGBP) announced today submission of a proposed experimental protocol to the FDA as part of ongoing discussions regarding initiation of a 10 patient aplastic anemia clinical trial utilizing the company's personalized adipose stem cell based therapy, HemaXellerate. The protocol submission was the result of a telephonic meeting with FDA officials, in which the Agency permitted the Company to provide additional input on preclinical safety experiments that need to be conducted before the clinical trial is initiated.
"The most important aspect of any novel therapeutic utility in humans is safety of the experimental product. We are grateful for the cooperation of the FDA in working with our scientists in ensuring the appropriate preclinical experimentation is performed, so as to minimize risk to the patient population," said David Koos, President and CEO of Regen BioPharma.
The HemaXellerate product utilizes the patient's own adipose derived stem cells, as well as therapeutic endothelial cells, to repair damaged bone marrow blood producing cells. The Company believes that successful proof-of-concept in aplastic anemia will position the HemaXellerate product for utilization in other conditions associated with deficient production of new blood cells. The scientific rationale behind HemaXellerate was previously published in the peer reviewed literature, with the article being available at this link http://www.translational-medicine.com/content...10-231.pdf
"In my opinion the greatest hurdle in advancement of HemaXellerate through the FDA process has been the demonstration of efficacy, manufacturing, and agreement on trial design, all of which we have come to agreement with the regulators on," said Thomas Ichim, Ph.D., Chief Scientific Officer of Regen BioPharma. "The current discussions with the FDA are about which test system is most reliable for demonstrating safety, which we believe will enhance the quality of our product, and also will make it easier for us to test HemaXellerate in future clinical trials for patients with other conditions."
About Regen BioPharma Inc.: Regen BioPharma Inc. (OTCBB: RGBP) is a majority owned subsidiary of Bio-Matrix Scientific Group, Inc. (PINKSHEETS: BMSN). Regen 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/
Disclaimer: 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.
CONTACT INFORMATION
Contact:
Regen BioPharma Inc.
David R. Koos, PhD
Chairman & Chief Executive Officer
Phone: 619-702-1404
Fax: 619.330.2328
www.regenbiopharma.com
Ongoing Dialogue With FDA Aimed at Initiating Clinical Trial for IND # 15376
SAN DIEGO, CA--(Marketwired - Oct 6, 2014) - Regen BioPharma Inc. (OTCBB: RGBP) announced today submission of a proposed experimental protocol to the FDA as part of ongoing discussions regarding initiation of a 10 patient aplastic anemia clinical trial utilizing the company's personalized adipose stem cell based therapy, HemaXellerate. The protocol submission was the result of a telephonic meeting with FDA officials, in which the Agency permitted the Company to provide additional input on preclinical safety experiments that need to be conducted before the clinical trial is initiated.
"The most important aspect of any novel therapeutic utility in humans is safety of the experimental product. We are grateful for the cooperation of the FDA in working with our scientists in ensuring the appropriate preclinical experimentation is performed, so as to minimize risk to the patient population," said David Koos, President and CEO of Regen BioPharma.
The HemaXellerate product utilizes the patient's own adipose derived stem cells, as well as therapeutic endothelial cells, to repair damaged bone marrow blood producing cells. The Company believes that successful proof-of-concept in aplastic anemia will position the HemaXellerate product for utilization in other conditions associated with deficient production of new blood cells. The scientific rationale behind HemaXellerate was previously published in the peer reviewed literature, with the article being available at this link http://www.translational-medicine.com/content...10-231.pdf
"In my opinion the greatest hurdle in advancement of HemaXellerate through the FDA process has been the demonstration of efficacy, manufacturing, and agreement on trial design, all of which we have come to agreement with the regulators on," said Thomas Ichim, Ph.D., Chief Scientific Officer of Regen BioPharma. "The current discussions with the FDA are about which test system is most reliable for demonstrating safety, which we believe will enhance the quality of our product, and also will make it easier for us to test HemaXellerate in future clinical trials for patients with other conditions."
About Regen BioPharma Inc.: Regen BioPharma Inc. (OTCBB: RGBP) is a majority owned subsidiary of Bio-Matrix Scientific Group, Inc. (PINKSHEETS: BMSN). Regen 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/
Disclaimer: 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.
CONTACT INFORMATION
Contact:
Regen BioPharma Inc.
David R. Koos, PhD
Chairman & Chief Executive Officer
Phone: 619-702-1404
Fax: 619.330.2328
www.regenbiopharma.com
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