Regen BioPharma, Inc. to Seek Orphan Drug Designation for Lead Product
Regen BioPharma (OTC Pink: RGBP) has announced plans to seek Orphan Drug Designation for HemaXellerate, its stem cell-derived therapy for treating aplastic anemia. The company has already received FDA clearance for Phase I clinical trials of this innovative treatment, which uses cells extracted from patients' fat tissue to stimulate bone marrow regeneration.
The potential Orphan Drug Designation would provide significant benefits, including a 25% tax credit on qualified clinical testing expenses and seven years of marketing exclusivity. The company is partnering with a specialized CRO to conduct the trials, expected to complete within 12-14 months. Beyond aplastic anemia, Regen sees opportunities in the $1 billion+ chemotherapy-induced bone marrow suppression market.
Regen BioPharma (OTC Pink: RGBP) ha annunciato l'intenzione di richiedere la Designazione di Farmaco Orfano per HemaXellerate, la sua terapia derivata da cellule staminali per il trattamento dell'anemia aplastica. L'azienda ha già ottenuto la approvazione FDA per gli studi clinici di Fase I di questo trattamento innovativo, che utilizza cellule prelevate dal tessuto adiposo dei pazienti per stimolare la rigenerazione del midollo osseo.
La possibile Designazione di Farmaco Orfano offrirebbe vantaggi significativi, tra cui un credito d'imposta del 25% sulle spese qualificate per i test clinici e sette anni di esclusiva commerciale. L'azienda sta collaborando con una CRO specializzata per condurre gli studi, che si prevede di completare entro 12-14 mesi. Oltre all'anemia aplastica, Regen individua opportunità nel mercato della soppressione del midollo osseo indotta da chemioterapia, che supera il miliardo di dollari.
Regen BioPharma (OTC Pink: RGBP) ha anunciado planes para solicitar la Designación de Medicamento Huérfano para HemaXellerate, su terapia derivada de células madre para tratar la anemia aplásica. La empresa ya ha recibido la aprobación de la FDA para ensayos clínicos de Fase I de este tratamiento innovador, que utiliza células extraídas del tejido graso de los pacientes para estimular la regeneración de la médula ósea.
La posible Designación de Medicamento Huérfano aportaría beneficios significativos, incluyendo un crédito fiscal del 25% sobre los gastos calificados en pruebas clínicas y siete años de exclusividad en el mercado. La empresa está colaborando con una CRO especializada para llevar a cabo los ensayos, que se espera completar en 12-14 meses. Más allá de la anemia aplásica, Regen ve oportunidades en el mercado de la supresión de médula ósea inducida por quimioterapia, que supera los mil millones de dólares.
Regen BioPharma (OTC Pink: RGBP)는 재생불능빈혈 치료를 위한 줄기세포 유래 치료제인 HemaXellerate에 대해 희귀의약품 지정(Orphan Drug Designation)을 신청할 계획이라고 발표했습니다. 이 회사는 이미 이 혁신적인 치료제에 대해 FDA의 1상 임상시험 승인을 받았으며, 환자의 지방 조직에서 추출한 세포를 사용하여 골수 재생을 촉진합니다.
희귀의약품 지정을 받으면 임상 시험 비용의 25% 세액 공제와 7년간의 시장 독점권 등 중요한 혜택이 제공됩니다. 회사는 전문 CRO와 협력하여 임상시험을 진행할 예정이며, 12-14개월 내에 완료할 것으로 예상됩니다. 재생불능빈혈 외에도, Regen은 10억 달러 이상 규모의 항암 화학요법 유발 골수 억제 시장에서 기회를 보고 있습니다.
Regen BioPharma (OTC Pink : RGBP) a annoncé son intention de demander la désignation de médicament orphelin pour HemaXellerate, sa thérapie dérivée de cellules souches destinée au traitement de l'anémie aplasique. La société a déjà obtenu l'autorisation de la FDA pour des essais cliniques de phase I de ce traitement innovant, qui utilise des cellules extraites du tissu adipeux des patients pour stimuler la régénération de la moelle osseuse.
La désignation de médicament orphelin offrirait des avantages importants, notamment un crédit d'impôt de 25 % sur les dépenses cliniques qualifiées et sept ans d'exclusivité commerciale. La société collabore avec un CRO spécialisé pour mener les essais, qui devraient être achevés en 12 à 14 mois. Au-delà de l'anémie aplasique, Regen entrevoit des opportunités sur le marché de la suppression de la moelle osseuse induite par la chimiothérapie, qui dépasse le milliard de dollars.
Regen BioPharma (OTC Pink: RGBP) hat Pläne angekündigt, eine Orphan Drug Designation für HemaXellerate zu beantragen, ihre aus Stammzellen entwickelte Therapie zur Behandlung der aplastischen Anämie. Das Unternehmen hat bereits die FDA-Zulassung für Phase-I-Studien dieser innovativen Behandlung erhalten, die Zellen aus dem Fettgewebe der Patienten verwendet, um die Knochenmarkregeneration zu fördern.
Die potenzielle Orphan Drug Designation würde erhebliche Vorteile bieten, darunter eine 25%ige Steuergutschrift auf qualifizierte klinische Testkosten und sieben Jahre Marktexklusivität. Das Unternehmen arbeitet mit einem spezialisierten CRO zusammen, um die Studien durchzuführen, die voraussichtlich innerhalb von 12-14 Monaten abgeschlossen sein werden. Über die aplastische Anämie hinaus sieht Regen Chancen im über 1 Milliarde Dollar schweren Markt für durch Chemotherapie verursachte Knochenmarkssuppression.
- FDA clearance received for Phase I clinical trials of HemaXellerate
- Potential for 7-year marketing exclusivity through Orphan Drug Designation
- 25% tax credit opportunity on qualified clinical testing expenses
- Access to $1 billion+ market opportunity in chemotherapy-induced bone marrow suppression
- Partnership established with experienced CRO for trial execution
- Clinical trial completion timeline of 12-14 months indicates lengthy development process
- Faces inherent risks and uncertainties in drug development and regulatory approval
- Operating in highly competitive immunology and immunotherapy space
An Orphan Drug Designation Could Provide Significant Benefits to Regen
SAN DIEGO, July 23, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC Pink: RGBP and RGBPP) today provides further insight into its planned Phase 1 clinical trial of HemaXellerate, the company’s innovative stem cell-derived therapy, which has already received FDA Investigational New Drug Application (IND) 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.
David Koos, the Chairman and CEO of Regen Biopharma, Inc., discussed the Company’s intention to seek Orphan Drug Designation for HemaXellerate, the Company’s proprietary aplastic anemia cell therapy drug candidate. This designation supports the development of medicines for rare disorders
“The incentives gained by being granted Orphan Drug designation would be substantial,” stated Koos. “These incentives include a tax credit equal to
The Company has been granted clearance by the United States FDA to initiate a Phase I clinical trial for HemaXellerate. 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.
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 anemiait 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. , “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 Regen BioPharma's (RGBP) HemaXellerate treatment and how does it work?
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