Regen BioPharma, Inc. Expands Vision for Phase 1 Clinical Trial of HemaXellerate™
Regen BioPharma (RGBP) has provided updates on its planned Phase 1 clinical trial for HemaXellerate™, a stem cell-derived therapy that received FDA clearance. The therapy aims to stimulate bone marrow regeneration, initially targeting aplastic anemia with potential expansion into chemotherapy-induced bone marrow suppression. The company has partnered with a specialized CRO to conduct the trial, which is expected to complete within 12-14 months. The targeted market for chemotherapy-induced bone marrow suppression is valued at over $1 billion annually.
Regen BioPharma (RGBP) ha fornito aggiornamenti riguardo il suo previsto studio clinico di Fase 1 per HemaXellerate™, una terapia derivata da cellule staminali che ha ricevuto l'approvazione della FDA. Questa terapia mira a stimolare la rigenerazione del midollo osseo, inizialmente mirata all'anemia aplastica, con potenziale espansione nella soppressione del midollo osseo indotta dalla chemioterapia. L'azienda ha stretto una partnership con un CRO specializzato per condurre lo studio, che si prevede sarà completato entro 12-14 mesi. Il mercato target per la soppressione del midollo osseo indotta dalla chemioterapia ha un valore di oltre $1 miliardo annualmente.
Regen BioPharma (RGBP) ha proporcionado actualizaciones sobre su ensayo clínico de Fase 1 planeado para HemaXellerate™, una terapia derivada de células madre que recibió la aprobación de la FDA. La terapia tiene como objetivo estimular la regeneración de la médula ósea, inicialmente enfocándose en la anemia aplástica, con una posible expansión en la supresión de la médula ósea inducida por quimioterapia. La compañía se ha asociado con un CRO especializado para llevar a cabo el ensayo, que se espera complete dentro de 12-14 meses. El mercado objetivo para la supresión de la médula ósea inducida por quimioterapia está valorado en más de $1 mil millones anuales.
Regen BioPharma (RGBP)는 HemaXellerate™의 예정된 1상 임상 시험에 대한 업데이트를 제공했습니다. 이 치료법은 FDA 승인을 받은 줄기세포 유래 치료법으로, 처음에는 재생불량성 anemia를 목표로 하며, 화학 요법으로 인한 골수 억제로의 확장을 가능하게 합니다. 회사는 임상 시험을 수행하기 위해 전문 CRO와 협력했으며, 이는 12-14개월 내에 완료될 것으로 예상됩니다. 화학 요법으로 인한 골수 억제의 목표 시장은 연간 $10억 이상의 가치를 가지고 있습니다.
Regen BioPharma (RGBP) a fourni des mises à jour sur son essai clinique de phase 1 prévu pour HemaXellerate™, une thérapie dérivée de cellules souches qui a reçu l'approbation de la FDA. Cette thérapie vise à stimuler la régénération de la moelle osseuse, en ciblant initialement l'anémie aplasique, avec une expansion potentielle dans la suppression de la moelle osseuse induite par la chimiothérapie. La société a établi un partenariat avec un CRO spécialisé pour mener l'essai, qui devrait être terminé dans un délai de 12 à 14 mois. Le marché ciblé pour la suppression de la moelle osseuse induite par chimiothérapie est évalué à plus de $1 milliard par an.
Regen BioPharma (RGBP) hat Updates zu seiner geplanten Phase-1-Studie für HemaXellerate™ bereitgestellt, einer Stammzelltherapie, die von der FDA genehmigt wurde. Die Therapie zielt darauf ab, die Regeneration des Knochenmarks zu stimulieren, wobei zunächst die aplastische Anämie im Fokus steht, mit einer potenziellen Erweiterung auf durch Chemotherapie induzierte Knochenmarksuppression. Das Unternehmen hat sich mit einem spezialisierten CRO zusammengetan, um die Studie durchzuführen, die voraussichtlich innerhalb von 12-14 Monaten abgeschlossen sein wird. Der Zielmarkt für durch Chemotherapie induzierte Knochenmarksuppression wird auf über $1 Milliarde jährlich geschätzt.
- FDA clearance received for HemaXellerate™ Phase 1 clinical trial
- Potential market expansion into $1B+ chemotherapy-induced bone marrow suppression sector
- Partnership established with specialized CRO for trial execution
- Clear timeline established: 12-14 months for trial completion
- Opportunity for accelerated regulatory pathways due to rare disease status
- Early-stage development (Phase 1) indicates long path to commercialization
- No revenue generation in immediate future
- Competition from established products like Neulasta in target market
Targeting Transformative Solutions for Aplastic Anemia and Beyond
SAN DIEGO, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC Pink: 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 FDA clearance. While the initial focus is on treating aplastic anemia, Regen BioPharma is evaluating expanded applications for this groundbreaking therapy in a market poised for significant growth.
HemaXellerate™ is designed to stimulate bone marrow regeneration following injury caused by autoimmune conditions, chemotherapy, or radiation. While the company’s initial target is aplastic anemia—a rare orphan indication—it sees substantial potential in treating chemotherapy-induced bone marrow suppression, a market valued at over
“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.
Key Highlights for Investors:
- 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 (PINK: RGBP) and (PINK: 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 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
+1-619-330-2328 Fax
Email: david.koos@regenbiopharmainc.com or
david.koos@regenbiopharma.com
X (formerly twitter): https://x.com/TheRegenBio
FAQ
What is the expected timeline for RGBP's HemaXellerate Phase 1 clinical trial?
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