Regen BioPharma Acquires Issued Patent And Preclinical Data Package For Targeting Cancer Stem Cell

SAN DIEGO, CA--(Marketwired - March 10, 2015) - Regen BioPharma Inc. (OTCBB: RGBP) (OTC PINK: RGBP) announced today successful closing of a transaction resulting in acquisition of issued US patent #8,263,571, and associated preclinical data package. The intellectual property covers specific therapeutic agents that gene silence CTCFL. CTCFL, otherwise known as Brother of the Regulator of Imprinted Sites (BORIS) is a gene that is critical for cancer stem cells to survive, in part by inducing expression of telomerase, a protein that creates cellular immortality(1).

Thomas Ichim, Ph.D., Chief Scientific Officer of Regen is co-inventor of the patent, which was filed in October 2007 by Vendevia Group. Through a private transaction, Dr. Ichim obtained assignment of the patent and preclinical package, which was subsequently assigned by Dr. Ichim to Regen.

“Having co-authored the peer-reviewed publication dating back to 2008 in which potent inhibition of breast cancer was demonstrated by gene silencing of CTCFL(2), and having assigned my own gene silencing/immunotherapy patent to Regen(3), I am highly enthusiastic that this very promising approach to killing cancer stem cells has now been brought under the Regen umbrella.” Stated Dr. Wei-Ping Min, Professor of Immunology at the University of Western Ontario and Member of Regen’s Scientific Advisory Board. “The use of RNA interference to kill cancer stem cells adds another powerful weapon in Regen’s arsenal on the war on cancer.”

CTCFL, also termed Brother of the Regulator of Imprinted Sites (BORIS) is a key protein that was originally discovered by Dr. Victor Lobanenkov at the NIH(4), which acts as a “master orchestrator” of numerous genes needed for cancer to maintain the properties of cancer(5). Dr. Ichim previously co-authored papers with NIH and other academic groups demonstrating that immunotherapy targeting CTCFL results in regression of breast cancer, leukemia, and glioma(6),(7),(8).

“Having worked for several years on developing the CTCFL gene-silencing therapeutic approach, and witnessing first-hand the promise of this technology in terms of specifically targeting tumor stem cells, I am excited that we identified a mechanism of bringing this highly complementary technology into Regen,” said Dr. Ichim. “Currently Regen is using gene silencing to block NR2F6 in cancer stem cells. The acquisition of the CTCFL intellectual property allows for performing experiments in parallel, thus significantly reducing developmental costs while doubling the probability of success.”

“The possession of an issued US patent in this rapidly evolving space allows for a wide range of possibilities ranging from internal development, to co-development, to outright licensing,” said David Koos, Chairman and CEO of Regen. “We have initiated discussions with entities in this industry in order to most rapidly optimize value of this asset.”

ABOUT REGEN BIOPHARMA INC.: Regen BioPharma Inc. is a publicly traded biotechnology company (OTCBB: RGBP) (OTC PINK: RGBP). The Company seeks to identify undervalued regenerative medicine applications in the immunotherapy and stem cell space. The Company is focused on rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials. Currently the Company is centering on gene silencing therapy for treating cancer, telomeres and small molecule therapies, along with developing stem cell treatments for aplastic anemia.

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.

(1) Alberti et al. High expression of hTERT and stemness genes in BORIS/CTCFL positive cells isolated from embryonic cancer cells. PLoS One. 2014 Oct 3;9(10):e109921

(2) Dougherty et al. Selective apoptosis of breast cancer cells by siRNA targeting of BORIS. Biochem Biophys Res Commun. 2008 May 23;370(1):109-12

(3) http://www.marketwired.com/press-release/bio-matrix-scientific-groups-subsidiary-regen-biopharma-announces-dcellvax-breast-cancer-otcqb-bmsn-1834547.htm

(4) Loukinov et al. BORIS, a novel male germ-line-specific protein associated with epigenetic reprogramming events, shares the same 11-zinc-finger domain with CTCF, the insulator protein involved in reading imprinting marks in the soma. Proc Natl Acad Sci U S A. 2002 May 14;99(10):6806-11.

(5) Vatolin et al. Conditional expression of the CTCF-paralogous transcriptional factor BORIS in normal cells results in demethylation and derepression of MAGE-A1 and reactivation of other cancer-testis genes. Cancer Res. 2005 Sep 1;65(17):7751-62.

(6) Loukinov et al. Antitumor efficacy of DNA vaccination to the epigenetically acting tumor promoting transcription factor BORIS and CD80 molecular adjuvant. J Cell Biochem. 2006 Aug 1;98(5):1037-43.

(7) Ghochikyan et al. Elicitation of T cell responses to histologically unrelated tumors by immunization with the novel cancer-testis antigen, brother of the regulator of imprinted sites. J Immunol. 2007 Jan 1;178(1):566-73.

(8) Mkrtichyan et al. DNA, but not protein vaccine based on mutated BORIS antigen significantly inhibits tumor growth and prolongs the survival of mice. Gene Ther. 2008 Jan;15(1):61-4.


Contact:
Regen BioPharma Inc.
David R. Koos, PhD
Chairman & Chief Executive Officer
619-702-1404 Phone
619-330-2328 Fax
www.regenbiopharma.com

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