Regen BioPharma, Inc. to Seek Orphan Drug Designation for Lead Product
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 groundbreaking therapy in a market poised for significant growth.
David Koos, the Chairman and CEO of Regen Biopharma, Inc., discussed the Company’s intention to seek Orphan Drug Designation for HemaXellerate, the Company’s proprietary aplastic anemia cell therapy drug candidate. This designation supports the development of medicines for rare disorders
“The incentives gained by being granted Orphan Drug designation would be substantial,” stated Koos. “These incentives include a tax credit equal to 25% of qualified clinical testing expenses (QCTEs) as well as up to seven years of marketing exclusivity. Regen intends to vigorously pursue Orphan Drug designation for HemaXellerate.”
The Company has been granted clearance by the United States FDA to initiate a Phase I clinical trial for HemaXellerate. HemaXellerate is comprised of cells extracted from the patient's own fat tissue and processed using a proprietary method to induce a biological response in the patient that heals damaged bone marrow and restores the body's ability to generate healthy blood cells.
HemaXellerate™ is designed to stimulate bone marrow regeneration following injury caused by autoimmune conditions, chemotherapy, or radiation. While the company’s initial target is aplastic anemiait sees substantial potential in treating chemotherapy-induced bone marrow suppression, a market valued at over $1 billion annually.
“Aplastic anemia patients without access to bone marrow transplantation face limited options,” said Dr. David Koos. , “With FDA clearance to begin clinical trials, HemaXellerate™ has the potential to redefine the treatment landscape—not just for aplastic anemia but for a wide range of hematological disorders. This is a pivotal moment for our company as we work to deliver life-changing therapies to patients worldwide.”
To ensure the trial’s success, Regen BioPharma has partnered with a clinical research organization (CRO) known for its expertise in conducting complex trials. Once initiated, the study is expected to reach completion within 12 to 14 months.
Key Highlights for Investors:
- Opportunity: Aplastic anemia is a rare disease with high unmet medical need, offering the potential for accelerated regulatory pathways and market exclusivity.
- Massive Market Potential: Expansion into chemotherapy-induced bone marrow suppression could unlock a multi-billion-dollar market.
- Strategic Execution: Collaboration with a leading CRO ensures focused execution and timeline adherence.
About Regen BioPharma, Inc.
Regen BioPharma, Inc. is a publicly traded biotechnology company (PINK: RGBP) and (PINK: RGBPP). The Company is focused on the immunology and immunotherapy space. The Company is focused on rapidly advancing novel technologies through pre-clinical and Phase I/ II clinical trials. Currently, the Company is focused on mRNA and small molecule therapies for treating cancer and autoimmune disorders. Additional information on Regen BioPharma is available at http://www.regenbiopharmainc.com.
Disclaimer: This news announcement may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.
CONTACT INFORMATION:
Regen BioPharma Inc.
David R. Koos, Ph.D.
Chairman & Chief Executive Officer
+1-619-722-5505 Phone
+1-619-330-2328 Fax
Email: david.koos@regenbiopharmainc.com or
david.koos@regenbiopharma.com
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