SAN DIEGO, August 16, 2016 /PRNewswire/ --
Regen BioPharma, Inc., (OTCQB: RGBP) and (OTCQB: RGBPP) announced today that the Pan Am Cancer Treatment Center in Tijuana, Mexico, which has a non-exclusive license to test HemaXellerate in a first-in-human proof of concept study, presented new interim clinical data on their first 5 patients. 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. Pan Am Cancer Treatment Center has now provided 3 month follow up data in these same patients. The primary endpoint of the study is safety and the secondary endpoint is effectiveness.
Regarding safety, none of the 5 patients had any adverse events. In other words, all of the patients tolerated HemaXellerate with no side-effects. Effectiveness was measured by taking blood tests of the patients 1 month and 3 months post-HemaXellerate treatment and measuring the levels of blood cells, particularly immune cells, circulating in their blood. As previously presented, at 1 month post-HemaXellerate treatment, 2 patients (40%) 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.
In the latest data presented, the patients who apparently benefited after one month maintained their high levels of white blood cells and all 5 patients had increased numbers of white blood cells after 3 months as compared to after 1 month. In addition, 4 out of 5 patients had increased numbers of red blood cells and all 5 patients had increased numbers of platelets 3 months after treatment as compared to after 1 month.
"These data are interesting. While there is no control group which would help us determine if this promising data are a consequence of HemaXellerate treatment, the apparent profound and sustained increase in white blood cell counts suggests that HemaXellerate may have some effectiveness," said Harry Lander, Ph.D., MBA, President and CSO. "Most important, it is clear that HemaXellerate was quite safe in these patients which is our primary concern."
"We were delighted that our licensees initiated this trial and that Regen could support them. It is gratifying to see that HemaXellerate may have some benefit to these patients," said Dr. David Koos, CEO. "Because this is an investigator-initiated trial we don't have control over the experimental design, but we are delighted that it is progressing. Let's remember, this is a first-in-human trial and so understanding the safety profile of HemaXellerate is critical."
HemaXellerate is comprised of cells extracted from the patient's own fat tissue and processed using a proprietary method so as to induce a biological response in the patient that heals damaged bone marrow and restores the body's ability to generate healthy blood cells. The FDA recently cleared Regen to perform Phase I clinical trials in the U.S. using HemaXellerate in aplastic anemia patients.
About Regen BioPharma, Inc.
Regen BioPharma Inc. is a publicly traded biotechnology company (OTCBB: RGBP) and (OTC PINK: RGBP) and (OTC PINK: RGBPP). 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.
Regen BioPharma Inc.
David R. Koos, PhD
Chairman & Chief Executive Officer
The Dorsee Company
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SOURCE Regen BioPharma Inc.