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FDA Gives OK for Regen BioPharma to Begin Clinical Trials

La Mesa-based Regen BioPharma Inc. has received clearance from the U.S. Food and Drug Administration (FDA) to start clinical trials of its lead drug candidate, HemaXellerate.

“The FDA clearance marks a substantial step for Regen, in that we are now a clinical-stage company,” said David Koos, chairman and CEO of Regen BioPharma, in a statement. “We believe the success of today will not only allow for the rapid execution of HemaXellerate’s development plan, but will also allow for more rapid translation of the company’s other immune modulatory products to the clinic.”

HemaXellerate is a personalized cellular therapeutic product designed to stimulate blood production in patients whose bone marrow is not properly functioning. Regen BioPharma’s initial Phase I clinical trial will treat aplastic anemia patients who haven’t responded to first-line immunosuppressive therapy. Because the trial will be unblinded, data will be available as the study progresses, according to a Regen news release.

“Current drug-based approaches for healing bone marrow dysfunction involve flooding the body with growth factors, which is extremely expensive and causes unintended consequences because of lack of selectivity,” said Harry Lander, president and chief scientific officer of Regen Biopharma, in a statement. “By utilizing a cell-based approach that both modulates the immune system and stimulates production of blood cells, we aim to offer alternatives to the current approaches to treating patients with aplastic anemia. This product will complement our immune-modulatory pipeline that includes a potential novel checkpoint inhibitor.”

If the clinical trial is successful, the company plans to expand the use of HemaXellerate to other conditions associated with bone marrow dysfunction, with the overall goal of entering the hematopoietic growth factor market, according to the release. This market is substantial in size and currently includes drugs such as Neupogen, Neulasta, Leukine and Revolade.

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