Regen BioPharma, Inc. is set to initiate a Phase 1 clinical trial of its stem cell-derived therapy, HemaXellerate™, following FDA clearance. The trial will initially focus on treating aplastic anemia, a rare orphan indication, while the company evaluates expanded applications for the therapy.
HemaXellerate™ is engineered to stimulate bone marrow regeneration following damage caused by autoimmune conditions, chemotherapy, or radiation. While the initial focus is on aplastic anemia, Regen BioPharma sees substantial potential in treating chemotherapy-induced bone marrow suppression, a market valued at over $1 billion annually.
Addressing Unmet Needs in Aplastic Anemia
"Aplastic anemia patients without access to bone marrow transplantation face limited options," said Dr. David Koos, Chairman and CEO of Regen BioPharma. He added, "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 and 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. The study is expected to reach completion within 12 to 14 months once initiated.
Potential Market and Future Applications
The company highlights that aplastic anemia, being a rare disease with high unmet medical need, offers the potential for accelerated regulatory pathways and market exclusivity. Furthermore, expansion into chemotherapy-induced bone marrow suppression could unlock a multi-billion-dollar market, similar to the success seen with products like Neulasta.
