SOURCE: Bio-Matrix Scientific Group, Inc.

September 10, 2014 10:01 ET

Regen BioPharma Provides Update on HemaXellerate IND Progress After Conference Call With FDA

Regen to Conduct GLP Safety Study to Provide Additional Supporting Data to FDA as the Company Moves Forward With HemaXellerate Development

SAN DIEGO, CA--(Marketwired - Sep 10, 2014) - Regen BioPharma Inc. (OTCBB: RGBP) announced today the outcome of a telephonic meeting with the FDA regarding IND #15376 for use of HemaXellerate in the treatment of aplastic anemia. The subject of this meeting with FDA cell therapy experts was the Company's existing experimental data and the requirement for additional safety data with regard to the IND application.

Regen had been previously notified by the FDA that it had cleared the clinical trial design, scientific rational and manufacturing components of its IND application. The Company was informed that before it is cleared to initiate a clinical trial, it must submit additional safety data from experiments conducted in a GLP certified laboratory. One of the reasons the FDA requested additional safety study data centers around the fact that HemaXellerate is a cell based drug. 

"We are grateful for the examiners at the FDA to have taken the time to walk us through their thinking and explaining to us what they believe will add the greatest level of safety to our HemaXellerate product. By closely working with the FDA now, we believe the path for future trials, including other disease indications will be much smoother," said Thomas Ichim, PhD, Chief Scientific Officer of Regen BioPharma Inc.

"Our first concern in product development is safety and the well being of patients participating in our planned future clinical trial. By leveraging the experience of the FDA and their cell therapy experts, we are confident that we will develop a strong product that will help aplastic anemia patients, which are currently without viable treatment options," said David Koos Chairman and CEO of Regen BioPharma Inc.

HemaXellerate is a personalized stem cell therapy that stimulates production of blood cells from the bone marrow of patients. Regen is planning to utilize HemaXellerate to treat patients with aplastic anemia, a condition associated with reduced ability of the bone marrow to make blood. The Company's CEO also stated, "If successful, the Company may expand into other conditions such as poor blood production associated with chemotherapy which is a potential multibillion dollar per year market."

About Regen BioPharma Inc.:
Regen BioPharma Inc., (OTCBB: RGBP) 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