Regen BioPharma Explores Expanded Use of HemaXellerate for Chemotherapy-Induced Bone Marrow Suppression

Rhea-AI Summary

Regen BioPharma (OTC:RGBP) announced plans to expand the development of HemaXellerate, its cellular therapy, to treat chemotherapy-induced bone marrow suppression. The company estimates a potential market exceeding $1 billion annually in the US alone.

HemaXellerate aims to address myelosuppression by stimulating hematopoietic stem cells to enhance recovery of all three major blood cell lines simultaneously. This approach differs from current treatments that typically target single blood cell lineages. The company is preparing for a Phase I study in aplastic anemia patients, with plans to expand into chemotherapy-related trials as a second indication.

Positive

• Potential market opportunity exceeding $1 billion annually in US
• Novel multi-lineage approach addressing all three blood cell types versus single-lineage current treatments
• Recent Orphan Drug Application submission for aplastic anemia indication
• Planned expansion into broader non-orphan indications

Negative

• Still in early development stages with Phase I trials yet to begin
• Will require significant clinical validation before commercialization
• Faces competition from established treatments in the market

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 the recent submission of an Orphan Drug Application for the treatment of aplastic anemia, Regen BioPharma is broadening its focus to include non-orphan indications where HemaXellerate may offer a transformative approach to unmet medical needs in oncology supportive care.

The Unmet Need in Chemotherapy-Induced Bone Marrow Suppression

Chemotherapy-induced bone marrow suppression, also known as myelosuppression, occurs when chemotherapy damages the bone marrow’s ability to produce blood cells. This condition results in anemia, neutropenia, and thrombocytopenia, which significantly increase the risks of fatigue, infection, and bleeding, often requiring dose reductions, treatment delays, or hospitalization.

Current standard-of-care treatments include:

• Colony-Stimulating Factors (e.g., G-CSF, GM-CSF): Promote white blood cell production but have limited effects on red cells or platelets.
• Erythropoiesis-Stimulating Agents (ESAs): Used for anemia but carry cardiovascular and thrombotic risks.
• Platelet transfusions: Temporary and often limited by availability and patient tolerance.
  

These therapies are largely single-lineage, symptomatic, and reactive. They do not address the root cause: damaged or suppressed hematopoietic stem cell function.

HemaXellerate: A Multi-Lineage Regenerative Approach

In contrast, HemaXellerate is designed to stimulate the body’s own hematopoietic stem cells, enhancing the recovery of all three major blood cell lines—erythrocytes, leukocytes, and platelets—simultaneously. Unlike traditional treatments that target specific symptoms or lineages, HemaXellerate acts upstream by restoring bone marrow microenvironment function and promoting endogenous hematopoiesis.

The stem cell literature indicates that HemaXellerate will:

• Accelerate bone marrow recovery following cytotoxic injury
• Enhance resilience to repeated chemotherapy cycles
• Reduce dependence on transfusions and secondary supportive drugs
  

A Potentially Game-Changing Therapy

"Chemotherapy-induced myelosuppression is a major limiting factor in effective cancer treatment,” said Dr. David Koos, Chairman and CEO of Regen BioPharma. “HemaXellerate represents a potentially game-changing therapy that not only treats the consequences of myelosuppression but targets its root cause by rejuvenating bone marrow function.”

Regen BioPharma is currently preparing for a Phase I study aimed at evaluating the safety and efficacy of HemaXellerate in aplastic anemia, with the goal of advancing to early-phase clinical trials in chemotherapy patients as a second indication thereafter.

About Regen BioPharma, Inc.

Regen BioPharma, Inc. is a clinical-stage biotechnology company focused on the development of innovative immunotherapies and regenerative medicine. The company’s pipeline includes novel cellular and small-molecule therapeutics that address unmet medical needs in cancer, hematologic disorders, and autoimmune diseases.

For more information, please visit: www.regenbiopharma.com

CONTACT INFORMATION:
Regen BioPharma Inc.
David R. Koos, Ph.D.
Chairman & Chief Executive Officer
+1-619-722-5505 Phone
Email: david.koos@regenbiopharmainc.com or
david.koos@regenbiopharma.com
X (formerly twitter): https://x.com/TheRegenBio 

FAQ

What is HemaXellerate and how does it work for chemotherapy patients?

HemaXellerate is a cellular therapy designed to stimulate hematopoietic stem cells, enhancing recovery of all three major blood cell lines (erythrocytes, leukocytes, and platelets) simultaneously by restoring bone marrow microenvironment function.

What is the market potential for Regen BioPharma's (RGBP) HemaXellerate?

The potential market for HemaXellerate in chemotherapy-induced bone marrow suppression is estimated to exceed $1 billion annually in the US market alone.

When will Regen BioPharma begin clinical trials for HemaXellerate?

Regen BioPharma is preparing to begin a Phase I study for HemaXellerate in aplastic anemia patients, followed by planned early-phase clinical trials for chemotherapy patients as a second indication.

How does HemaXellerate differ from current bone marrow suppression treatments?

Unlike current treatments that target specific symptoms or single blood cell lineages, HemaXellerate addresses the root cause by rejuvenating bone marrow function and promoting recovery of all three major blood cell lines simultaneously.

What conditions will Regen BioPharma's HemaXellerate treat?

HemaXellerate is being developed to treat aplastic anemia (primary indication) and chemotherapy-induced bone marrow suppression (planned second indication), which causes anemia, neutropenia, and thrombocytopenia in cancer patients.