SAN DIEGO, May 11, 2016 /PRNewswire/ --
Regen BioPharma, Inc., (OTCBB: RGBP), (OTCPINK: RGBP) and (OTCPINK: RGBPP) announced today that potential market expansion of its HemaXellerate therapy for aplastic anemia is a strategic priority.
The Company intends to amend its previously submitted Investigational New Drug Application for HemaXellerate in order that Regen may obtain consent from the United States Food and Drug Administration (FDA) to pursue both a Phase I clinical trial assessing HemaXellerate in patients with drug-refractory aplastic anemia (which the FDA has already cleared Regen to perform) and a Phase I clinical trial assessing HemaXellerate in patients suffering from chemotherapy-based bone marrow suppression.
The Company's management based this decision on previously reported data from the Pan Am Cancer Treatment Center in Tijuana, Mexico. Beginning in March 2016, 5 patients with chemotherapy-induced bone marrow suppression were treated with HemaXellerate and initial 1 month follow up data were provided which demonstrated that none of the 5 patients had any adverse events, 2 patients had a dramatic increase in their circulating white blood cells to levels even above the normal range, and 2 other patients had their white blood cells return to the normal range.
While the market for treating aplastic anemia in patients is small, the market for patients that have developed bone marrow suppression as a result of chemotherapy is over $5 billion (http://www.jnccn.org/content/13/1/e1.long). This anticipated future expansion dramatically benefits not only the potential patients suffering from a major side effect of chemotherapy but will also grow the potential future revenue stream for the Company.
Regen's Chairman & CEO David Koos noted: "We believe that HemaXellerate is an important treatment for aplastic anemia and the potential to expand into treating severe bone marrow suppression could be very beneficial to both patients and the Company as there is a large population suffering from bone marrow suppression."
Regen BioPharma Inc. is a biotechnology company that 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 focusing on checkpoint inhibitor and gene silencing therapies for treating cancer, along with developing stem cell treatments for aplastic anemia. The company has cleared an investigational new drug application (IND) with the U. S. Food and Drug Administration (FDA) and is preparing to enter Clinical Phase I in the treatment for aplastic anemia.
About Regen BioPharma, Inc.
Regen BioPharma Inc. is a publicly traded biotechnology company (OTCBB: RGBP), (OTCPINK: RGBP) and (OTC PINK: RGBPP). The company seeks to identify undervalued regenerative medicine applications in the immunotherapy and stem cell space. The company aims to rapidly advance these technologies through pre-clinical and Phase I/II clinical trials. Currently the company is focusing on checkpoint inhibitor and gene silencing therapies for treating cancer, 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.
Regen BioPharma Inc.
David R. Koos, PhD
Chairman & Chief Executive Officer
The Dorsee Company
SOURCE Regen BioPharma Inc.