Core Points - Regen BioPharma, Inc. is presenting an update on its Orphan Drug application for HemaXellerate, aimed at treating aplastic anemia and potentially addressing chemotherapy side effects, which represents a multi-billion dollar market [1][2] - The Company is preparing to enter Clinical Phase I for HemaXellerate, which has already received FDA clearance [2] Company Overview - Regen BioPharma, Inc. is a publicly traded biotechnology company focused on immunology and immunotherapy, advancing novel technologies through pre-clinical and Phase I/II clinical trials [4] - The Company is currently concentrating on mRNA and small molecule therapies for cancer and autoimmune disorders [4]

Core Viewpoint - Regen BioPharma is addressing comments from the FDA regarding its Orphan Drug Application for HemaXellerate, aimed at treating aplastic anemia, a rare and serious bone marrow disorder [1][3]. Company Overview - Regen BioPharma, Inc. is a publicly traded biotechnology company focused on immunology and immunotherapy, advancing novel technologies through pre-clinical and Phase I/II clinical trials [8]. Product Details - HemaXellerate is a novel, cell-based therapeutic designed to stimulate bone marrow activity and restore hematopoietic function, representing a significant milestone in the company's mission to develop innovative therapies for patients with limited options [2][5]. - The product is an autologous mesenchymal stem cell product expected to reverse the effects of aplastic anemia-induced bone marrow suppression [5]. Regulatory Aspects - The Orphan Drug Application is a major step for the company, as receiving orphan drug designation from the FDA would provide regulatory and commercial advantages, including seven years of market exclusivity, tax credits for clinical testing, and exemption from certain FDA application fees [3][4]. Market Context - Aplastic anemia is characterized by insufficient blood cell production, leading to severe health issues such as fatigue and infections, with current treatment options being limited and often ineffective [4].

Core Insights - Regen BioPharma is advancing the clinical development of HemaXellerate, a novel cellular therapy aimed at addressing chemotherapy-induced bone marrow suppression, representing a potential market exceeding $1 billion annually in the US [1][2] Industry Overview - Chemotherapy-induced bone marrow suppression, or myelosuppression, significantly impairs the bone marrow's ability to produce blood cells, leading to conditions such as anemia, neutropenia, and thrombocytopenia, which increase risks of fatigue, infection, and bleeding [3] - Current standard-of-care treatments are largely single-lineage, symptomatic, and reactive, failing to address the underlying issue of damaged hematopoietic stem cell function [3][7] HemaXellerate's Approach - HemaXellerate aims to stimulate the body's own hematopoietic stem cells, enhancing recovery of erythrocytes, leukocytes, and platelets simultaneously, by restoring bone marrow microenvironment function and promoting endogenous hematopoiesis [4] - This regenerative approach contrasts with traditional treatments that target specific symptoms or blood cell lineages [4] Potential Impact - Dr. David Koos, Chairman and CEO of Regen BioPharma, emphasized that HemaXellerate could be a game-changing therapy, addressing both the consequences and root causes of myelosuppression by rejuvenating bone marrow function [5] - The company is preparing for a Phase I study to evaluate the safety and efficacy of HemaXellerate in aplastic anemia, with plans to advance to early-phase clinical trials in chemotherapy patients thereafter [5] Company Profile - Regen BioPharma, Inc. is a clinical-stage biotechnology company focused on developing innovative immunotherapies and regenerative medicine, with a pipeline that includes cellular and small-molecule therapeutics targeting unmet medical needs in cancer, hematologic disorders, and autoimmune diseases [6]

SAN DIEGO, Aug. 15, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC ID: RGBP and RGBPP) today provided further insight into its planned Phase 1 clinical trial of HemaXellerate, the company’s innovative stem cell-derived therapy, which has already received U.S. FDA clearance. While the initial focus is on treating aplastic anemia, a rare orphan indication, Regen BioPharma is evaluating expanded applications for this groundbreaking therapy in markets poised for significant growth. Regen sees substantial p ...

Core Insights - Regen BioPharma is advancing its Phase 1 clinical trial for HemaXellerate, a stem cell-derived therapy aimed at treating aplastic anemia, with potential for broader applications in a growing market [1][2][3] Company Overview - Regen BioPharma, Inc. is a publicly traded biotechnology company focused on immunology and immunotherapy, advancing novel technologies through pre-clinical and Phase I/II clinical trials [7] Orphan Drug Designation - The company intends to seek Orphan Drug Designation for HemaXellerate, which would provide significant incentives, including a 25% tax credit on qualified clinical testing expenses and up to seven years of marketing exclusivity [2][9] Clinical Trial Details - The FDA has granted clearance for the Phase I clinical trial of HemaXellerate, which utilizes cells from the patient's own fat tissue to stimulate bone marrow regeneration [2][4] - The trial is expected to be completed within 12 to 14 months, supported by a partnership with a clinical research organization known for its expertise [4][9] Market Potential - Aplastic anemia is a rare disease with high unmet medical needs, presenting opportunities for accelerated regulatory pathways and market exclusivity [9] - The potential expansion into treating chemotherapy-induced bone marrow suppression could tap into a market valued at over $1 billion annually [3][9]