Regen BioPharma, Inc. to Seek Orphan Drug Designation for Lead Product

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]