Regen BioPharma Completes Preclinical Experiments for dCellVax Breast Cancer Immune Therapy
Company Begins Preparation for Filing of Investigational New Drug (IND) Application With FDA
SAN DIEGO, CA--(Marketwired - Oct 1, 2014) - Regen BioPharma Inc. (OTCBB: RGBP) announced today completion of its preclinical experiments supporting the use of dCellVax, a personalized breast cancer immunotherapy. Animal studies, which have been previously published in peer-reviewed journals (1, 2), demonstrated that dCellVax is effective at stimulating the immune system of animals to kill tumors. In order to apply these findings to humans, proof of concept in human cells was needed.
In the press release of Aug 1st, 2014 the Company reported successful silencing of the IDO gene in human dendritic cells (DC) treated with newly developed proprietary gene-silencing technology which was in part licensed from Benitec Biopharma. Today the Company reports that dCellVax generated according to the protocols that will be submitted to the FDA was capable of potently stimulating human T cells to kill breast cancer cells. Combined with animal model efficacy data, GMP-grade manufacturing protocols, and animal safety data, the Company believes it has completed the necessary experimental work to begin writing its IND for a proposed clinical trial in breast cancer patients.
"Today marks the accomplishment of a major milestone in the dCellVax program. Based on the preclinical data generated by us and our collaborators, we are confident moving forward to the FDA in requesting permission to initiate human trials through the IND mechanisms," said Thomas Ichim, Ph.D., Chief Scientific Officer of Regen BioPharma. "Given the enthusiasm in the oncology community for immune modulatory approaches such as checkpoint inhibitors and CAR-T cell approaches, we are confident in rapid acceptance of the dCellVax immunotherapy by physicians."
Immunotherapy offers the possibility of killing tumors by harnessing the power of the immune system. This type of treatment generally lacks the toxicity associated with chemotherapy or radiotherapy and is capable of killing metastatic cells, which usually cause relapse in cancer patients. dCellVax is an immunotherapy using DC generated from breast cancer patients which have been modified so as to lack an enzyme, indolamine 2,3 deoxygenase (IDO) that inhibits the immune response. By lacking this enzyme, the modified DC become potent stimulators of the immune system, a finding which was confirmed by the experiments completed today.
"Cellular therapy is considered one of the next major advances in medicine. By combining these two approaches, we believe we are well positioned to generate a new treatment in the fight against breast cancer," said David Koos, Chairman and CEO of Regen BioPharma.
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.
(1) Zheng et al. Silencing IDO in dendritic cells: a novel approach to enhance cancer immunotherapy in a murine breast cancer model. Int J Cancer. 2013 Feb 15;132(4):967-77).
(2) Zheng et al. Reinstalling antitumor immunity by inhibiting tumor-derived immunosuppressive molecule IDO through RNA interference. J Immunol. 2006 Oct 15;177(
:5639-46
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
Company Begins Preparation for Filing of Investigational New Drug (IND) Application With FDA
SAN DIEGO, CA--(Marketwired - Oct 1, 2014) - Regen BioPharma Inc. (OTCBB: RGBP) announced today completion of its preclinical experiments supporting the use of dCellVax, a personalized breast cancer immunotherapy. Animal studies, which have been previously published in peer-reviewed journals (1, 2), demonstrated that dCellVax is effective at stimulating the immune system of animals to kill tumors. In order to apply these findings to humans, proof of concept in human cells was needed.
In the press release of Aug 1st, 2014 the Company reported successful silencing of the IDO gene in human dendritic cells (DC) treated with newly developed proprietary gene-silencing technology which was in part licensed from Benitec Biopharma. Today the Company reports that dCellVax generated according to the protocols that will be submitted to the FDA was capable of potently stimulating human T cells to kill breast cancer cells. Combined with animal model efficacy data, GMP-grade manufacturing protocols, and animal safety data, the Company believes it has completed the necessary experimental work to begin writing its IND for a proposed clinical trial in breast cancer patients.
"Today marks the accomplishment of a major milestone in the dCellVax program. Based on the preclinical data generated by us and our collaborators, we are confident moving forward to the FDA in requesting permission to initiate human trials through the IND mechanisms," said Thomas Ichim, Ph.D., Chief Scientific Officer of Regen BioPharma. "Given the enthusiasm in the oncology community for immune modulatory approaches such as checkpoint inhibitors and CAR-T cell approaches, we are confident in rapid acceptance of the dCellVax immunotherapy by physicians."
Immunotherapy offers the possibility of killing tumors by harnessing the power of the immune system. This type of treatment generally lacks the toxicity associated with chemotherapy or radiotherapy and is capable of killing metastatic cells, which usually cause relapse in cancer patients. dCellVax is an immunotherapy using DC generated from breast cancer patients which have been modified so as to lack an enzyme, indolamine 2,3 deoxygenase (IDO) that inhibits the immune response. By lacking this enzyme, the modified DC become potent stimulators of the immune system, a finding which was confirmed by the experiments completed today.
"Cellular therapy is considered one of the next major advances in medicine. By combining these two approaches, we believe we are well positioned to generate a new treatment in the fight against breast cancer," said David Koos, Chairman and CEO of Regen BioPharma.
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.
(1) Zheng et al. Silencing IDO in dendritic cells: a novel approach to enhance cancer immunotherapy in a murine breast cancer model. Int J Cancer. 2013 Feb 15;132(4):967-77).
(2) Zheng et al. Reinstalling antitumor immunity by inhibiting tumor-derived immunosuppressive molecule IDO through RNA interference. J Immunol. 2006 Oct 15;177(
:5639-46 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
