SAN DIEGO, September 25, 2015 /PRNewswire/ --
Post# of 373
Posted On: 09/25/2015 6:59:13 PM
SAN DIEGO, September 25, 2015 /PRNewswire/ --
Final Experiments Requested by FDA Completed
Regen BioPharma Inc. (OTCBB: RGBP) and (OTC PINK: RGBP) announced today receipt of the audited draft report from contract research organization Charles River, describing positive conclusions derived from animal safety studies requested by the FDA regarding Regen's Investigational New Drug (IND) Application #15376 covering HemaXellerate (a proposed therapy for treating aplastic anemia).
The experiments comprised of administering HemaXellerate in male and female mice lacking an immune system, and observation of the animals under Good Laboratory Practices. The report concluded that doses of up to 10 times higher than those that will be used in the proposed clinical trial were well tolerated and did not result in cell-related mortality, adverse clinical observations or changes in body weights.
"Completion of these experiments with positive results strongly supports the further clinical development of HemaXellerate, which is a personalized cell based therapy aimed at treatment of drug refractory aplastic anemia and other disorders of blood cell production," said Thomas Ichim, PhD, Chief Scientific Officer of Regen BioPharma. "Given the rigor used by Charles River in conduct of the experiments, and the detailed analysis of numerous physiological parameters, we are confident that the FDA will accept this data and allow initiation of our proposed 10 patient clinical trial."
HemaXellerate is a patient-specific composition of cells that have previously been demonstrated to repair damaged bone marrow and stimulate production of blood cells based on previous animal studies. The Company, together with an internationally-renowned group of stem cell researchers, published the scientific basis for the HemaXellerate I™ product which may be found at http://www.translational-medicine.com/content...10-231.pdf.
"Safety of patients is our first priority. We are grateful to the FDA for advising us on the design of the completed safety studies, which will ensure we deliver a high quality product to patients in the proposed clinical trial," said David Koos, Chairman and CEO of Regen BioPharma.
ABOUT REGEN BIOPHARMA INC.: Regen BioPharma Inc. is a publicly traded biotechnology company (OTCBB: RGBP) and (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.
CONTACT INFORMATION
Regen BioPharma Inc.
David R. Koos, PhD
Chairman & Chief Executive Officer
+1-619-702-1404 Phone
+1-619-330-2328 Fax
http://www.regenbiopharma.com
david.koos@regenbiopharma.com
SOURCE Regen BioPharma Inc.
Final Experiments Requested by FDA Completed
Regen BioPharma Inc. (OTCBB: RGBP) and (OTC PINK: RGBP) announced today receipt of the audited draft report from contract research organization Charles River, describing positive conclusions derived from animal safety studies requested by the FDA regarding Regen's Investigational New Drug (IND) Application #15376 covering HemaXellerate (a proposed therapy for treating aplastic anemia).
The experiments comprised of administering HemaXellerate in male and female mice lacking an immune system, and observation of the animals under Good Laboratory Practices. The report concluded that doses of up to 10 times higher than those that will be used in the proposed clinical trial were well tolerated and did not result in cell-related mortality, adverse clinical observations or changes in body weights.
"Completion of these experiments with positive results strongly supports the further clinical development of HemaXellerate, which is a personalized cell based therapy aimed at treatment of drug refractory aplastic anemia and other disorders of blood cell production," said Thomas Ichim, PhD, Chief Scientific Officer of Regen BioPharma. "Given the rigor used by Charles River in conduct of the experiments, and the detailed analysis of numerous physiological parameters, we are confident that the FDA will accept this data and allow initiation of our proposed 10 patient clinical trial."
HemaXellerate is a patient-specific composition of cells that have previously been demonstrated to repair damaged bone marrow and stimulate production of blood cells based on previous animal studies. The Company, together with an internationally-renowned group of stem cell researchers, published the scientific basis for the HemaXellerate I™ product which may be found at http://www.translational-medicine.com/content...10-231.pdf.
"Safety of patients is our first priority. We are grateful to the FDA for advising us on the design of the completed safety studies, which will ensure we deliver a high quality product to patients in the proposed clinical trial," said David Koos, Chairman and CEO of Regen BioPharma.
ABOUT REGEN BIOPHARMA INC.: Regen BioPharma Inc. is a publicly traded biotechnology company (OTCBB: RGBP) and (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.
CONTACT INFORMATION
Regen BioPharma Inc.
David R. Koos, PhD
Chairman & Chief Executive Officer
+1-619-702-1404 Phone
+1-619-330-2328 Fax
http://www.regenbiopharma.com
david.koos@regenbiopharma.com
SOURCE Regen BioPharma Inc.
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