Regen BioPharma Discusses Potential Impact of HemaXellerate on Chemotherapy Treament Market
Regen BioPharma (OTC:RGBP) has provided updates on its FDA-cleared Phase 1 clinical trial for HemaXellerate, a stem cell-derived therapy initially targeting aplastic anemia. The therapy, derived from patients' fat tissue, aims to stimulate bone marrow regeneration and restore blood cell production capabilities.
The company is exploring expansion into the chemotherapy-induced bone marrow suppression market, valued at over $1 billion annually. The clinical trial, managed by a specialized CRO, is expected to complete within 12-14 months. HemaXellerate's potential applications extend beyond aplastic anemia to various hematological disorders, positioning it as a potentially transformative treatment option.
Regen BioPharma (OTC:RGBP) ha comunicato aggiornamenti sul suo trial clinico di Fase 1 approvato dalla FDA per HemaXellerate, una terapia derivata da cellule staminali sviluppata inizialmente per l'anemia aplastica. La terapia, ottenuta dal tessuto adiposo dei pazienti, è pensata per stimolare la rigenerazione del midollo osseo e ripristinare la produzione di cellule del sangue.
L'azienda sta valutando un'espansione verso il mercato della soppressione midollare indotta da chemioterapia, stimato oltre 1 miliardo di dollari all'anno. Il trial clinico, condotto da una CRO specializzata, dovrebbe concludersi entro 12-14 mesi. Le possibili applicazioni di HemaXellerate vanno oltre l'anemia aplastica e comprendono diversi disturbi ematologici, collocandola come potenziale terapia trasformativa.
Regen BioPharma (OTC:RGBP) ha ofrecido novedades sobre su ensayo clínico de Fase 1 aprobado por la FDA para HemaXellerate, una terapia derivada de células madre desarrollada inicialmente para la anemia aplásica. La terapia, obtenida del tejido adiposo de los pacientes, busca estimular la regeneración de la médula ósea y restaurar la producción de células sanguíneas.
La compañía está explorando expandirse al mercado de supresión medular inducida por quimioterapia, valorado en más de 1.000 millones de dólares anuales. El ensayo clínico, gestionado por una CRO especializada, se espera que finalice en 12-14 meses. Las aplicaciones potenciales de HemaXellerate se extienden más allá de la anemia aplásica a varios trastornos hematológicos, posicionándola como una opción terapéutica potencialmente transformadora.
Regen BioPharma (OTC:RGBP)는 FDA 승인된 1상 임상시험에 대한 최신 정보를 공개했습니다. 해당 시험은 HemaXellerate에 대한 것으로, 이 치료제는 원래 재생불량성빈혈을 타깃으로 한 줄기세포 유래 치료제입니다. 환자의 지방 조직에서 유래한 이 치료제는 골수 재생을 촉진하고 혈구 생산 기능을 회복시키는 것을 목표로 합니다.
회사는 연간 10억 달러 이상 규모로 평가되는 항암화학요법 유발 골수억제 시장으로의 확장 가능성도 검토하고 있습니다. 임상시험은 전문 CRO가 관리하며 12~14개월 내 완료될 것으로 예상됩니다. HemaXellerate의 잠재적 적용 범위는 재생불량성빈혈을 넘어서 다양한 혈액질환으로 확장되어, 혁신적 치료 옵션이 될 가능성이 있습니다.
Regen BioPharma (OTC:RGBP) a communiqué des mises à jour sur son essai clinique de phase 1 approuvé par la FDA pour HemaXellerate, une thérapie issue de cellules souches initialement destinée à l'anémie aplasique. La thérapie, dérivée du tissu adipeux des patients, vise à stimuler la régénération de la moelle osseuse et à restaurer la production de cellules sanguines.
La société envisage de s'étendre au marché de la suppression médullaire induite par la chimiothérapie, évalué à plus de 1 milliard de dollars par an. L'essai clinique, géré par une CRO spécialisée, devrait se terminer dans un délai de 12 à 14 mois. Les applications potentielles de HemaXellerate dépassent l'anémie aplasique et s'étendent à divers troubles hématologiques, ce qui en fait une option thérapeutique potentiellement transformative.
Regen BioPharma (OTC:RGBP) hat Neuigkeiten zu seiner von der FDA freigegebenen Phase-1-Studie für HemaXellerate veröffentlicht, einer aus Stammzellen gewonnenen Therapie, die ursprünglich auf aplastische Anämie abzielt. Die aus dem Fettgewebe der Patienten gewonnene Therapie soll die Regeneration des Knochenmarks anregen und die Blutbildung wiederherstellen.
Das Unternehmen prüft eine Ausweitung auf den Markt für chemotherapiebedingte Knochenmarksuppression, der auf über 1 Milliarde US-Dollar jährlich geschätzt wird. Die klinische Studie wird von einer spezialisierten CRO betreut und soll innerhalb von 12–14 Monaten abgeschlossen sein. Die potenziellen Einsatzgebiete von HemaXellerate reichen über die aplastische Anämie hinaus und umfassen verschiedene hämatologische Erkrankungen, was sie zu einer möglicherweise bahnbrechenden Behandlungsoption macht.
- FDA clearance received for Phase 1 clinical trial of HemaXellerate
- Potential market opportunity exceeding $1 billion annually in chemotherapy-induced bone marrow suppression
- Partnership with experienced CRO for trial execution
- Possibility for accelerated regulatory pathways and market exclusivity due to orphan indication status
- Clinical trial completion timeline of 12-14 months indicates delayed revenue potential
- Early-stage development carries significant regulatory and clinical risks
- Competition in the billion-dollar market could be substantial
SAN DIEGO, Aug. 15, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC ID: RGBP and RGBPP) today provided further insight into its planned Phase 1 clinical trial of HemaXellerate, the company’s innovative stem cell-derived therapy, which has already received U.S. FDA clearance. While the initial focus is on treating aplastic anemia, a rare orphan indication, Regen BioPharma is evaluating expanded applications for this groundbreaking therapy in markets poised for significant growth.
Regen sees substantial potential in treating chemotherapy-induced bone marrow suppression, a market projected to be valued at well in excess of
- HemaXellerate is comprised of cells extracted from the patient's own fat tissue and processed using a proprietary method to induce a biological response in the patient that heals damaged bone marrow and restores the body's ability to generate healthy blood cells.
“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.”
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.
- Opportunity: Aplastic anemia is a rare disease with high unmet medical need, offering the potential for accelerated regulatory pathways and market exclusivity.
- Massive Market Potential: Expansion into chemotherapy-induced bone marrow suppression could unlock a multi-billion-dollar market.
- Strategic Execution: Collaboration with a leading CRO ensures focused execution and timeline adherence.
About Regen BioPharma, Inc.
Regen BioPharma, Inc. is a publicly traded biotechnology company (OTC ID: RGBP) and (OTC ID: RGBPP). The Company is focused on the immunology and immunotherapy space. The Company is focused on rapidly advancing novel technologies through pre-clinical and Phase I/ II clinical trials. Currently, the Company is focused on mRNA and small molecule therapies for treating cancer and autoimmune disorders. Additional information on Regen BioPharma is available at http://www.regenbiopharmainc.com.
Disclaimer: This news announcement may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward-looking statements are subject to include, but are not limited to, the effect of government regulation, competition and other material risks.
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 Regen BioPharma's HemaXellerate therapy and how does it work?
What is the market potential for RGBP's HemaXellerate therapy?
When will Regen BioPharma complete the Phase 1 clinical trial for HemaXellerate?
What regulatory advantages does RGBP's HemaXellerate have?
How is Regen BioPharma (RGBP) planning to execute the HemaXellerate clinical trial?
