Regen Receives Green Light From FDA to Proceed With GLP Safety Study in Support of Its HemaXellerate Investigational New Drug Application
Company Believes GLP Safety Study Is the Last Hurdle for HemaXellerate IND
(firmenpresse) - SAN DIEGO, CA -- (Marketwired) -- 03/17/15 -- Regen BioPharma Inc. (OTCBB: RGBP) (OTC PINK: RGBP) announced today that it has received final comments and authorization from the FDA to proceed with its GLP Safety Study in support of the company''s HemaXellerate Investigational New Drug application (IND) which is on file with the FDA.
Dr. Thomas Ichim stated, "The FDA has reviewed our protocols for the GLP Safety Study. They made several comments which have been incorporated into our protocols. The next step is for Regen to commence this study. Once completed, the results will be presented to the FDA. We believe that this process represents the last hurdle for Regen''s HemaXellerate IND to clear before we are allowed to move into clinical trials."
Regen''s Chairman & CEO David Koos said, "We are excited to see HemaXellerate progressing. It is anticipated that once the HemaXellerate GLP Safety Study is completed and the data have been presented to the FDA, Regen should be able to move on towards clinical trials. This is a huge step forward for the Company to reach this point."
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.
Contact:
Regen BioPharma Inc.
David R. Koos, PhD
Chairman & Chief Executive Officer
619-702-1404 Phone
619-330-2328 Fax
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Datum: 17.03.2015 - 07:30 Uhr
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