SAN DIEGO, CA--(Marketwired - January 08, 2015) - Regen BioPharma Inc. (OTCBB: RGBP) announced today the discovery and demonstration of in vitro efficacy of a second generation of gene silencing drug candidates with specificity to the cancer stem cell gene NR2F6.
The Company has rights to an invention covered by a non-provisional patent application disclosing compositions of matter, protocols and methods of use of treatment for cancer and other diseases of aberrant cellular proliferation. The patent covers the use of its proprietary novel candidates administered as short interfering nucleic acid (siNA) antisense, short interfering RNA (siRNA), double-stranded RNA (dsRNA), micro-RNA (miRNA), and short hairpin RNA (shRNA).
Proof-of-concept studies originally identifying NR2F6 as a target for cancer stem cells were performed by Dr. Christine Ichim, senior research consultant with Regen Biopharma, along with scientists at the University of Toronto. These studies showed that silencing of the NR2F6 gene in leukemia cells led to the cells losing their leukemic characteristics. This finding was the subject of a US patent application "Modulation of NR2F6 and methods and uses thereof" which was assigned to Regen BioPharma. The data was subsequently published in the peer-reviewed journal Leukemia(1).
"The identification of novel means of more effectively blocking the NR2F6 gene provides a series of therapeutic candidates that we plan to develop as therapeutic agents, initially for leukemia, and subsequently for solid tumors," stated David Koos, Chairman and CEO of Regen BioPharma. "As we plan on rapidly moving these new drugs through the IND process, we want to ensure that our candidates have the most potent in vitro activity possible before engaging in preclinical efficacy and toxicity studies. Accordingly, we believe that the newly identified candidates are exceedingly more potent in activity when compared to the first generation compounds."
Cancer stem cells, also known as the cancer initiating cells, are the cells in a cancer that are tumorigenic, meaning they have the ability to cause formation of new tumors when implanted in animals. Blocking their ability to self-renew by silencing NR2F6 transforms cancer cells in to a non-tumorigenic state by guiding cells toward a process called differentiation and cellular maturation.
"Developing of therapeutics that target cancer stem cells and transform them into non-tumorigenic cells through the process of differentiation is anticipated to dramatically improve the way we treat cancer," said Dr. Christine Ichim. "At a conceptual level, one of the major failures of cancer therapy is the desire to chemically kill the cancer cell. The cancer cell, which possesses properties of normal cells, has protective mechanisms against being killed. Specifically, when chemotherapy is administered, cancer cells start to produce drug resistance proteins, which act as cellular pumps, that remove the chemotherapy from inside of the cell, thus resulting in treatment resistance. In contrast, the approach being developed by Regen involves 'coaxing' the cancer cell to turn into a normal cell."
Stimulation of cancer cells to convert or "differentiate" into normal cells has been previously used successfully in patients with acute promyelocytic leukemia (APL)(2), where cure rates of > 80% have been reported by administration of agents that modulate retinoic acid receptor, a nuclear receptor(3). The Company is working on the hypothesis that blocking of specific nuclear receptors, may result in a similar type of "leukemic differentiation," which would be applicable to a broader range of cancers.
"The findings of novel candidate sequences to improve gene silencing of NR2F6 is a fundamental advancement in our work towards biologically treating cancer," said Dr. Thomas Ichim, Chief Scientific Officer. "Given that Regen BioPharma is already clinically developing gene-silencing therapeutics in its IND for dCellVax, we anticipate substantial synergy of these programs."
About Regen BioPharma Inc.: Regen BioPharma Inc. (OTCBB: RGBP) is a majority owned subsidiary of Bio-Matrix Scientific Group, Inc. (OTC PINK: 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.
(1) Ichim et al. Identification of a role for the nuclear receptor EAR-2 in the maintenance of clonogenic status within the leukemia cell hierarchy. Leukemia. 2011 Nov;25(11):1687-96
(2) Warrell et al. Differentiation Therapy of Acute Promyelocytic Leukemia with Tretinoin (All-trans-Retinoic Acid). N Engl J Med 1991; 324:1385-1393.
(3) Lo-Coco et al. Retinoic acid and arsenic trioxide for acute promyelocytic leukemia. N Engl J Med. 2013 Jul 11;369(2):111-21