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Regen BioPharma Expands HemaXellerate Trial Scope Beyond Aplastic Anemia

  • Regen BioPharma's HemaXellerate, a stem cell-derived therapy, has received FDA clearance for a Phase 1 clinical trial initially focused on aplastic anemia.
  • The company is exploring the potential of HemaXellerate to treat chemotherapy-induced bone marrow suppression, a market with a multi-billion dollar valuation.
  • Regen BioPharma has partnered with a specialized CRO to ensure efficient execution and completion of the clinical trial within 12-14 months.
  • HemaXellerate aims to stimulate bone marrow regeneration following injury from autoimmune conditions, chemotherapy, or radiation, addressing a significant unmet need.
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.
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Reference News

[1]
Regen BioPharma, Inc. Expands Vision for Phase 1 Clinical Trial of HemaXellerate
biospace.com · Nov 19, 2024

Regen BioPharma plans Phase 1 trial of HemaXellerate™, a stem cell-derived therapy targeting aplastic anemia, with poten...

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