Hemogenyx Pharmaceuticals (HOPHF) has received FDA clearance to expand its Phase I clinical trial of HG-CT-1, a proprietary CAR-T therapy for relapsed/refractory acute myeloid leukemia (R/R AML), to include pediatric and adolescent patients. The FDA's 30-day review period concluded without a clinical hold, allowing the company to proceed with Institutional Review Board submissions and site activation procedures for pediatric cohorts. This expansion broadens the potential therapeutic reach of HG-CT-1 and represents a significant milestone in the company's development program, particularly in addressing the needs of younger patients with this aggressive form of leukemia.
Hemogenyx Pharmaceuticals (HOPHF) ha ottenuto l'approvazione dalla FDA per ampliare la sua sperimentazione clinica di Fase I di HG-CT-1, una terapia CAR-T proprietaria per la leucemia mieloide acuta recidivante/refrattaria (R/R AML), includendo pazienti pediatrici e adolescenti. Il periodo di revisione di 30 giorni della FDA si 猫 concluso senza sospensioni cliniche, consentendo all'azienda di procedere con le sottomissioni al Comitato Etico e l'attivazione dei siti per le coorti pediatriche. Questa espansione amplia il potenziale terapeutico di HG-CT-1 e rappresenta un traguardo importante nel programma di sviluppo dell'azienda, in particolare nel rispondere alle esigenze dei pazienti pi霉 giovani affetti da questa forma aggressiva di leucemia.
Hemogenyx Pharmaceuticals (HOPHF) ha recibido la aprobaci贸n de la FDA para ampliar su ensayo cl铆nico de Fase I de HG-CT-1, una terapia CAR-T patentada para la leucemia mieloide aguda recidivante/refractaria (R/R AML), incluyendo a pacientes pedi谩tricos y adolescentes. El per铆odo de revisi贸n de 30 d铆as de la FDA concluy贸 sin una suspensi贸n cl铆nica, lo que permite a la compa帽铆a avanzar con las presentaciones ante la Junta de Revisi贸n Institucional y los procedimientos de activaci贸n de sitios para las cohortes pedi谩tricas. Esta expansi贸n ampl铆a el alcance terap茅utico potencial de HG-CT-1 y representa un hito significativo en el programa de desarrollo de la empresa, especialmente en la atenci贸n a las necesidades de los pacientes j贸venes con esta forma agresiva de leucemia.
Hemogenyx Pharmaceuticals (HOPHF) a obtenu l'autorisation de la FDA pour 茅tendre son essai clinique de phase I de HG-CT-1, une th茅rapie CAR-T propri茅taire destin茅e 脿 la leuc茅mie my茅lo茂de aigu毛 r茅cidivante/r茅fractaire (R/R AML), afin d'inclure des patients p茅diatriques et adolescents. La p茅riode d'examen de 30 jours par la FDA s'est termin茅e sans suspension clinique, permettant 脿 la soci茅t茅 de poursuivre les soumissions aupr猫s des comit茅s d'茅thique institutionnels et les proc茅dures d'activation des sites pour les cohortes p茅diatriques. Cette extension 茅largit le potentiel th茅rapeutique de HG-CT-1 et constitue une 茅tape importante dans le programme de d茅veloppement de l'entreprise, notamment pour r茅pondre aux besoins des patients plus jeunes atteints de cette forme agressive de leuc茅mie.
Hemogenyx Pharmaceuticals (HOPHF) hat von der FDA die Genehmigung erhalten, seine Phase-I-Studie mit HG-CT-1, einer propriet盲ren CAR-T-Therapie f眉r rezidivierende/refrakt盲re akute myeloische Leuk盲mie (R/R AML), auf p盲diatrische und jugendliche Patienten auszuweiten. Die 30-t盲gige 脺berpr眉fungsfrist der FDA endete ohne klinische Unterbrechung, was dem Unternehmen erlaubt, mit den Einreichungen bei den Ethikkommissionen und der Aktivierung der Studienzentren f眉r die p盲diatrischen Kohorten fortzufahren. Diese Erweiterung erh枚ht die potenzielle therapeutische Reichweite von HG-CT-1 und stellt einen bedeutenden Meilenstein im Entwicklungsprogramm des Unternehmens dar, insbesondere im Hinblick auf die Bed眉rfnisse j眉ngerer Patienten mit dieser aggressiven Leuk盲mieform.
Positive
FDA clearance received for pediatric expansion of HG-CT-1 clinical trial, expanding the potential market and therapeutic applications
Successful completion of FDA review period without clinical hold indicates positive safety profile
Expansion to pediatric patients strengthens the company's intellectual property portfolio and market position
Negative
None.
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS STIPULATED UNDER THE UK VERSION OF THE MARKET ABUSE REGULATION NO 596/2014 WHICH IS PART OF ENGLISH LAW BY VIRTUE OF THE EUROPEAN (WITHDRAWAL) ACT 2018, AS AMENDED. ON PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.
Regulatory Clearance to Proceed with Pediatric Expansion of HG-CT-1 Clinical Trial
LONDON, UK / / June 17, 2025 / Hemogenyx Pharmaceuticals plc (LSE:HEMO) is pleased to announce that the 30-day review period by the U.S. Food and Drug Administration (FDA) for the Company's to the clinical protocol of its ongoing Phase I trial of HG-CT-1 has concluded without a clinical hold. As a result, the Company is now cleared to proceed with the next steps required to initiate pediatric enrolment in the trial.
The protocol amendment expands the eligibility criteria for the Phase I trial of HG-CT-1, Hemogenyx's proprietary CAR-T therapy for relapsed/refractory acute myeloid leukemia (R/R AML), to include children and adolescents with this aggressive and hard-to-treat disease.
The Company will now move forward with Institutional Review Board (IRB) submissions and associated site activation procedures to enable the opening of pediatric cohorts.
Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "Regulatory clearance to proceed with the pediatric expansion of our HG-CT-1 clinical trial is a significant milestone. It reflects continued momentum in our development program and underscores our commitment to delivering innovative therapies to patients across age groups. This expansion broadens the potential impact and value of HG-CT-1 as we continue to advance toward key inflection points in the clinic. Importantly, it also reinforces the value of Company's robust intellectual property portfolio, which underpins our pipeline and supports long-term strategic growth."
The Company will update the market as further progress is made in pediatric site activation and patient enrolment.
Market Abuse Regulation (MAR) Disclosure
Certain information contained in this announcement would have been inside information for the purposes of Article 7 of Regulation No 596/2014 (as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018) until the release of this announcement. The person responsible for arranging for the release of this announcement on behalf of Hemogenyx Pharmaceuticals plc is Dr Vladislav Sandler, Chief Executive Officer & Co-Founder.
Enquiries:
Hemogenyx Pharmaceuticals plc
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder
Hemogenyx Pharmaceuticals is a publicly traded company (LSE: HEMO) headquartered in London, with its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility.
The Company is a clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as platform technologies that it uses as engines for novel product development.
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact [email protected] or visit .
SOURCE: Hemogenyx Pharmaceuticals PLC
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FAQ
What is the significance of FDA clearance for Hemogenyx's (HOPHF) pediatric trial expansion?
The FDA clearance allows Hemogenyx to include children and adolescents in its Phase I trial of HG-CT-1, expanding the potential therapeutic reach for treating relapsed/refractory acute myeloid leukemia (R/R AML).
What is HG-CT-1 and what condition does it treat?
HG-CT-1 is Hemogenyx's proprietary CAR-T therapy designed to treat relapsed/refractory acute myeloid leukemia (R/R AML), an aggressive and hard-to-treat blood cancer.
What are the next steps for Hemogenyx (HOPHF) following FDA clearance?
The company will proceed with Institutional Review Board (IRB) submissions and site activation procedures to begin enrolling pediatric patients in the clinical trial.
How does the pediatric expansion affect Hemogenyx's (HOPHF) business potential?
The expansion broadens HG-CT-1's potential market impact, strengthens the company's intellectual property portfolio, and supports long-term strategic growth by addressing a wider patient population.
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