Regen BioPharma, Inc. is broadening the scope of its Phase 1 clinical trial for HemaXellerate™, a stem cell-derived therapy, beyond its initial focus on aplastic anemia. The company received FDA clearance for the trial and is now evaluating the therapy's potential in treating chemotherapy-induced bone marrow suppression.
HemaXellerate™ is designed to stimulate bone marrow regeneration following damage caused by autoimmune conditions, chemotherapy, or radiation. While the initial target is aplastic anemia, a rare orphan indication, Regen BioPharma sees substantial potential in treating chemotherapy-induced bone marrow suppression, a market valued at over $1 billion annually. This is evidenced by the success of products like Neulasta, which addresses similar unmet needs.
Addressing Unmet Needs in Hematological Disorders
"Aplastic anemia patients without access to bone marrow transplantation face limited options," said Dr. David Koos, Chairman and CEO of Regen BioPharma. "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."
Strategic Partnerships for Trial Execution
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.
Market Opportunity and Strategic Execution
Aplastic anemia presents a rare disease with high unmet medical need, offering the potential for accelerated regulatory pathways and market exclusivity. Expansion into chemotherapy-induced bone marrow suppression could unlock a multi-billion-dollar market. Collaboration with a leading CRO ensures focused execution and timeline adherence.
