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 th ...

公司动态 - Regen BioPharma公司旗下创新干细胞疗法HemaXellerate已获得美国FDA批准进入I期临床试验 初始适应症为罕见病再生障碍性贫血 同时探索化疗所致骨髓抑制等扩展适应症[1] - HemaXellerate疗法采用患者自体脂肪组织提取细胞 通过专利技术诱导生物反应 修复受损骨髓并恢复健康血细胞生成能力[2] - 公司已与知名临床研究组织(CRO)达成合作 预计临床试验将在12-14个月内完成[2] 市场前景 - 化疗所致骨髓抑制市场规模预计超过10亿美元/年 是HemaXellerate疗法的潜在扩展市场[2] - 再生障碍性贫血领域存在高度未满足的临床需求 可能获得加速审批通道和市场独占权[6] - 首席执行官David Koos表示该疗法有望重塑血液疾病治疗格局 包括但不限于再生障碍性贫血[2] 技术平台 - 公司专注于免疫学与免疫治疗领域 重点推进mRNA和小分子药物治疗癌症及自身免疫疾病[4] - 当前研发管线集中在临床前和I/II期试验阶段 采用差异化技术路径[4]

An Orphan Drug Designation Could Provide Significant Benefits to Regen SAN DIEGO, July 23, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC Pink: RGBP and RGBPP) today provides further insight into its planned Phase 1 clinical trial of HemaXellerate, the company's innovative stem cell-derived therapy, which has already received FDA Investigational New Drug Application (IND) clearance. While the initial focus is on treating aplastic anemia, Regen BioPharma is evaluating expanded applications for this grou ...