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SAN DIEGO, October 24, 2016 /PRNewswire/ --
Regen BioPharma, Inc., (OTCQB: RGBP) and (OTCQB: RGBPP) announced today that the Pan Am Cancer Treatment Center in Tijuana, Mexico presented final 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 and 6 month follow up data in these same patients. The primary endpoint of the study is safety and the secondary endpoint is effectiveness. Pan Am Cancer Treatment Center has been granted a non-exclusive license to test HemaXellerate in a first-in-human proof of concept study.
With regards to safety, none of the 5 patients experienced 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, 3 and 6 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 all 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 6 months as compared to after 1 month. In addition, all 5 patients had increased numbers of red blood cells and increased numbers of platelets 6 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 appears that HemaXellerate treatment resulted in no adverse effects in these patients. Safety is, after all, our primary concern."
"We were delighted that our licensee initiated this trial and that Regen could support them. It is gratifying to see that HemaXellerate appears to benefit these patients," said Dr. David Koos, CEO. "Because this is an investigator-initiated trial we don't have control over the experimental design. 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 US FDA recently cleared Regen to initiate 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 (OTCQB: RGBP) and (OTCQB: 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 focused on gene silencing therapy and small molecule therapies for treating cancer and autoimmune diseases, along with developing stem cell treatments for aplastic anemia and disorders of the bone marrow. Additional information on Regen BioPharma is available at http://www.regenbiopharmainc.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.
Contact: Regen BioPharma Inc. David R. Koos, PhD Chairman & Chief Executive Officer +1-619-702-1404 Phone +1-619-330-2328 Fax [email protected] http://www.regenbiopharma.com http://www.regenbiopharmainc.com [email protected] The Dorsee Company Debra Dorsee +1-858-229-6082 [email protected] Twitter: Regen BioPharma News: @RegenBioPharm
SOURCE Regen BioPharma, Inc.
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Regen BioPharma, Inc., (OTCQB: RGBP) and (OTCQB: RGBPP) announced today that the Pan Am Cancer Treatment Center in Tijuana, Mexico presented final 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 and 6 month follow up data in these same patients. The primary endpoint of the study is safety and the secondary endpoint is effectiveness. Pan Am Cancer Treatment Center has been granted a non-exclusive license to test HemaXellerate in a first-in-human proof of concept study.
With regards to safety, none of the 5 patients experienced 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, 3 and 6 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 all 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 6 months as compared to after 1 month. In addition, all 5 patients had increased numbers of red blood cells and increased numbers of platelets 6 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 appears that HemaXellerate treatment resulted in no adverse effects in these patients. Safety is, after all, our primary concern."
"We were delighted that our licensee initiated this trial and that Regen could support them. It is gratifying to see that HemaXellerate appears to benefit these patients," said Dr. David Koos, CEO. "Because this is an investigator-initiated trial we don't have control over the experimental design. 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 US FDA recently cleared Regen to initiate 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 (OTCQB: RGBP) and (OTCQB: 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 focused on gene silencing therapy and small molecule therapies for treating cancer and autoimmune diseases, along with developing stem cell treatments for aplastic anemia and disorders of the bone marrow. Additional information on Regen BioPharma is available at http://www.regenbiopharmainc.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.
Contact: Regen BioPharma Inc. David R. Koos, PhD Chairman & Chief Executive Officer +1-619-702-1404 Phone +1-619-330-2328 Fax [email protected] http://www.regenbiopharma.com http://www.regenbiopharmainc.com [email protected] The Dorsee Company Debra Dorsee +1-858-229-6082 [email protected] Twitter: Regen BioPharma News: @RegenBioPharm
SOURCE Regen BioPharma, Inc.
