GM-CSF(Sun Yat-sen University)

Regen’s Approach Could Be Paradigm Shift in Supportive Oncology Care SAN DIEGO, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC PINK: RGBP) today announced its ongoing efforts to expand the clinical development of HemaXellerate, its novel cellular therapy, to address chemotherapy-induced bone marrow suppression, a serious and common complication in cancer patients undergoing cytotoxic treatments. This represents potentially a market in excess of $1 billion per year in just the US. Following the recent submission of an Orphan Drug Application for the treatment of aplastic anemia, Regen BioPharma is broadening its focus to include non-orphan indications where HemaXellerate may offer a transformative approach to unmet medical needs in oncology supportive care. The Unmet Need in Chemotherapy-Induced Bone Marrow Suppression Chemotherapy-induced bone marrow suppression, also known as myelosuppression, occurs when chemotherapy damages the bone marrow’s ability to produce blood cells. This condition results in anemia, neutropenia, and thrombocytopenia, which significantly increase the risks of fatigue, infection, and bleeding, often requiring dose reductions, treatment delays, or hospitalization. Current standard-of-care treatments include: Colony-Stimulating Factors (e.g., G-CSF, GM-CSF): Promote white blood cell production but have limited effects on red cells or platelets.Erythropoiesis-Stimulating Agents (ESAs): Used for anemia but carry cardiovascular and thrombotic risks.Platelet transfusions: Temporary and often limited by availability and patient tolerance. These therapies are largely single-lineage, symptomatic, and reactive. They do not address the root cause: damaged or suppressed hematopoietic stem cell function. HemaXellerate: A Multi-Lineage Regenerative Approach In contrast, HemaXellerate is designed to stimulate the body’s own hematopoietic stem cells, enhancing the recovery of all three major blood cell lines—erythrocytes, leukocytes, and platelets—simultaneously. Unlike traditional treatments that target specific symptoms or lineages, HemaXellerate acts upstream by restoring bone marrow microenvironment function and promoting endogenous hematopoiesis. The stem cell literature indicates that HemaXellerate will: Accelerate bone marrow recovery following cytotoxic injuryEnhance resilience to repeated chemotherapy cyclesReduce dependence on transfusions and secondary supportive drugs A Potentially Game-Changing Therapy "Chemotherapy-induced myelosuppression is a major limiting factor in effective cancer treatment,” said Dr. David Koos, Chairman and CEO of Regen BioPharma. “HemaXellerate represents a potentially game-changing therapy that not only treats the consequences of myelosuppression but targets its root cause by rejuvenating bone marrow function.” Regen BioPharma is currently preparing for a Phase I study aimed at evaluating the safety and efficacy of HemaXellerate in aplastic anemia, with the goal of advancing to early-phase clinical trials in chemotherapy patients as a second indication thereafter. About Regen BioPharma, Inc. Regen BioPharma, Inc. is a clinical-stage biotechnology company focused on the development of innovative immunotherapies and regenerative medicine. The company’s pipeline includes novel cellular and small-molecule therapeutics that address unmet medical needs in cancer, hematologic disorders, and autoimmune diseases. For more information, please visit: www.regenbiopharma.com CONTACT INFORMATION:Regen BioPharma Inc.David R. Koos, Ph.D.Chairman & Chief Executive Officer+1-619-722-5505 PhoneEmail: david.koos@regenbiopharmainc.com ordavid.koos@regenbiopharma.comX (formerly twitter): https://x.com/TheRegenBio