Regen BioPharma Explores Expanded Use of HemaXellerate for Chemotherapy-Induced Bone Marrow Suppression
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.
Regen BioPharma (OTC:RGBP) ha annunciato l'intenzione di ampliare lo sviluppo di HemaXellerate, la sua terapia cellulare, per trattare la soppressione del midollo osseo indotta dalla chemioterapia. La società stima un potenziale mercato superiore a 1 miliardo di dollari all'anno solo negli Stati Uniti.
HemaXellerate punta a contrastare la mielosoppressione stimolando le cellule staminali ematopoietiche per favorire il recupero simultaneo delle tre principali linee cellulari del sangue. Questo approccio si distingue dai trattamenti attuali, che in genere agiscono su singole linee cellulari ematiche. L'azienda si sta preparando per uno studio di Fase I su pazienti con anemia aplastica, con l'intenzione di estendere successivamente le sperimentazioni ai casi correlati alla chemioterapia come seconda indicazione.
Regen BioPharma (OTC:RGBP) anunció planes para ampliar el desarrollo de HemaXellerate, su terapia celular, para tratar la supresión de la médula ósea inducida por la quimioterapia. La compañía estima un mercado potencial superior a 1.000 millones de dólares anuales solo en EE. UU.
HemaXellerate busca combatir la mielosupresión estimulando las células madre hematopoyéticas para mejorar la recuperación simultánea de las tres principales líneas celulares sanguíneas. Este enfoque difiere de los tratamientos actuales, que suelen dirigirse a una sola línea celular sanguínea. La empresa se está preparando para un estudio de Fase I en pacientes con anemia aplásica, con planes de ampliar posteriormente los ensayos a pacientes afectados por quimioterapia como segunda indicación.
Regen BioPharma (OTC:RGBP)는 자사의 세포치료제 HemaXellerate를 항암화학요법으로 인한 골수억제 치료로 확장 개발할 계획을 발표했습니다. 회사는 미국에서만 연간 10억 달러가 넘는 시장이 존재할 것으로 추정하고 있습니다.
HemaXellerate는 조혈모세포를 자극하여 세 가지 주요 혈액 세포 계통 모두의 회복을 동시에 촉진함으로써 골수억제를 해결하는 것을 목표로 합니다. 이 접근법은 보통 단일 혈액 계통을 표적하는 기존 치료법과 다릅니다. 회사는 재생불량성 빈혈 환자를 대상으로 한 1상(Phase I) 시험을 준비 중이며, 두 번째 적응증으로 항암요법 관련 임상으로 확장할 계획입니다.
Regen BioPharma (OTC:RGBP) a annoncé son intention d'étendre le développement de HemaXellerate, sa thérapie cellulaire, pour traiter la suppression médullaire induite par la chimiothérapie. La société estime un marché potentiel dépassant 1 milliard de dollars par an rien qu'aux États-Unis.
HemaXellerate vise à lutter contre la myélosuppression en stimulant les cellules souches hématopoïétiques afin d'améliorer la récupération simultanée des trois principales lignées cellulaires sanguines. Cette approche diffère des traitements actuels, qui ciblent généralement une seule lignée cellulaire sanguine. L'entreprise se prépare à une étude de phase I chez des patients atteints d'anémie aplasique, avec l'intention d'étendre ensuite les essais aux cas liés à la chimiothérapie comme seconde indication.
Regen BioPharma (OTC:RGBP) kündigte Pläne an, die Entwicklung von HemaXellerate, seiner Zelltherapie, zur Behandlung der durch Chemotherapie verursachten Knochenmarkssuppression auszubauen. Das Unternehmen schätzt einen potenziellen Markt von über 1 Milliarde US-Dollar jährlich allein in den USA.
HemaXellerate zielt darauf ab, Myelosuppression zu behandeln, indem hämatopoetische Stammzellen stimuliert werden, um die Erholung aller drei großen Blutlinien gleichzeitig zu verbessern. Dieser Ansatz unterscheidet sich von aktuellen Behandlungen, die typischerweise einzelne Blutlinien ansprechen. Das Unternehmen bereitet eine Phase-I-Studie bei Patienten mit aplastischer Anämie vor und plant, die Studien als zweite Indikation auf chemotherapiebedingte Fälle auszuweiten.
- 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
- 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
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
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