SOURCE: Regen BioPharma Inc.

October 08, 2014 12:28 ET

Regen BioPharma Inc. Files IND Application With FDA for dCellVax Breast Cancer Immune Therapy

Cell Therapy and Gene Silencing Combined for New Treatment of Advanced Breast Cancer

Anticipated Clinical Trials to Validate dCellVax Platform, Allow for Expansion Into Other Cancers

dCellVax Can Be Integrated Into Existing Therapeutic Regimens, Synergy With Checkpoint Inhibitors

SAN DIEGO, CA--(Marketwired - Oct 8, 2014) - Regen BioPharma Inc. (OTCBB: RGBP) announced today the filing of an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) to initiate a clinical trial assessing safety and therapeutic effects of dCellVax in patients with metastatic breast cancer. dCellVax is an immunotherapeutic product that utilizes the patient's own immune cells to attack the tumor. Success of dCellVax in the proposed trial is anticipated to pave the way for expanded use of dCellVax in a variety of other tumors. Advantages of cancer immune therapies include: a) lack of toxicity; b) ability to attack tumor metastasis; and c) generation of immunological memory, which protects the body from recurrence of the tumor.

"Today marks a significant milestone for Regen BioPharma Inc., by filing our second IND application, we are accomplishing our original mission statement, which was to accelerate translation of nascent intellectual property from academia into viable therapeutic products," said David Koos, President and CEO of Regen BioPharma. "We are thankful for Dr. Wei-Ping Min and his team at the University of Western Ontario, who have worked diligently with us over the last 18 months in making this IND application a reality."

dCellVax has been developed based on US patent #8,389,708, acquired from Dr. Wei-Ping Min, as well as a collaboration between Dr. Min and the Company's Chief Science Officer Dr. Thomas Ichim, which has spanned over 10 years. Together Dr. Min and Dr. Ichim have published 37 peer reviewed papers in the area of gene silencing and immune modulation. Additionally, the Company obtained an exclusive license from Benitec Biopharma covering the use of RNA interference to silence the molecule that is being inhibited in the generation of dCellVax.

"The dCellVax approach to cancer is different than other gene silencing therapeutics currently in development. Most companies use gene silencing to block abnormal genes found in the tumor (oncogenes). Unfortunately, to get tumor cure with this approach, one would need to silence 100% of the cancer cells, otherwise, the remaining cells will continue to multiply. Achieving silencing in 100% of cancer cells is next to impossible. With the dCellVax approach, we are silencing genes that suppress the immune response to cancer. With this approach, even achieving silencing in 20% of immune cells is enough to cause an increased immune response, which hopefully will overcome the tumor," said Dr. Ichim. "To our knowledge this is the first time that gene silencing is being proposed as a means of overcoming immune suppression in a clinical situation."

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