Hemogenyx Pharmaceuticals PLC Announces Pediatric Amendment to Clinical Protocol
Hemogenyx Pharmaceuticals (LSE:HEMO) has filed an amendment to its ongoing Phase I clinical trial protocol for HG-CT-1, its CAR-T therapy for relapsed/refractory acute myeloid leukemia (R/R AML). The amendment seeks to expand trial eligibility to include children and adolescents, beyond the current adult patient population. This expansion aims to address a critical unmet medical need in pediatric oncology, particularly for R/R AML, which has limited treatment options and poor prognosis. The company has already treated two patients in the adult cohort of the trial.
Hemogenyx Pharmaceuticals (LSE:HEMO) ha presentato una modifica al protocollo del suo attuale studio clinico di Fase I per HG-CT-1, la sua terapia CAR-T per la leucemia mieloide acuta recidivante/refrattaria (R/R AML). La modifica mira ad ampliare l'idoneità allo studio includendo bambini e adolescenti, oltre alla popolazione adulta attualmente coinvolta. Questa estensione intende rispondere a un bisogno medico critico non soddisfatto nell'oncologia pediatrica, in particolare per la R/R AML, che presenta opzioni terapeutiche limitate e una prognosi sfavorevole. L'azienda ha già trattato due pazienti nel gruppo adulto dello studio.
Hemogenyx Pharmaceuticals (LSE:HEMO) ha presentado una enmienda al protocolo de su ensayo clínico de Fase I en curso para HG-CT-1, su terapia CAR-T para leucemia mieloide aguda en recaída/refractaria (R/R AML). La enmienda busca ampliar la elegibilidad del ensayo para incluir a niños y adolescentes, además de la población adulta actual. Esta expansión tiene como objetivo abordar una necesidad médica crítica no cubierta en oncología pediátrica, especialmente para R/R AML, que cuenta con opciones de tratamiento limitadas y un pronóstico desfavorable. La compañía ya ha tratado a dos pacientes en la cohorte adulta del ensayo.
Hemogenyx Pharmaceuticals(LSE:HEMO)는 재발/불응성 급성 골수성 백혈병(R/R AML)을 위한 CAR-T 치료제 HG-CT-1의 진행 중인 1상 임상시험 프로토콜에 대한 수정안을 제출했습니다. 이번 수정안은 현재 성인 환자군을 넘어 소아 및 청소년을 포함하도록 시험 대상자를 확대하는 것을 목표로 합니다. 이 확장은 소아 종양학에서 중요한 미충족 의료 수요, 특히 치료 옵션이 제한적이고 예후가 좋지 않은 R/R AML에 대응하기 위한 것입니다. 회사는 이미 성인 환자군에서 두 명의 환자를 치료했습니다.
Hemogenyx Pharmaceuticals (LSE:HEMO) a déposé un amendement au protocole de son essai clinique de Phase I en cours pour HG-CT-1, sa thérapie CAR-T pour la leucémie myéloïde aiguë en rechute/réfractaire (R/R AML). Cet amendement vise à élargir l'éligibilité à l'essai afin d'inclure les enfants et les adolescents, au-delà de la population adulte actuelle. Cette extension a pour but de répondre à un besoin médical critique non satisfait en oncologie pédiatrique, notamment pour la R/R AML, qui dispose de peu d'options thérapeutiques et présente un pronostic défavorable. La société a déjà traité deux patients dans la cohorte adulte de l'essai.
Hemogenyx Pharmaceuticals (LSE:HEMO) hat eine Änderung des laufenden Phase-I-Studienprotokolls für HG-CT-1, seine CAR-T-Therapie für rezidivierende/refraktäre akute myeloische Leukämie (R/R AML), eingereicht. Die Änderung soll die Einschlusskriterien der Studie erweitern, um neben der derzeitigen erwachsenen Patientengruppe auch Kinder und Jugendliche einzubeziehen. Diese Erweiterung zielt darauf ab, einen kritischen ungedeckten medizinischen Bedarf in der pädiatrischen Onkologie zu adressieren, insbesondere bei R/R AML, die nur begrenzte Behandlungsmöglichkeiten und eine schlechte Prognose aufweist. Das Unternehmen hat bereits zwei Patienten in der erwachsenen Kohorte der Studie behandelt.
- Expansion of potential patient population for HG-CT-1 therapy to include pediatric patients
- Progress in clinical trials with first two adult patients already treated
- Addressing an unmet medical need in pediatric oncology with limited treatment options
- Still in early Phase I trials with limited patient data
- Success in adult patients may not translate to pediatric population
Amendment to Clinical Protocol for HG-CT-1 to Include Pediatric Patients with R/R AML
LONDON, UNITED KINGDOM / ACCESS Newswire / May 14, 2025 / Hemogenyx Pharmaceuticals plc (LSE:HEMO) is pleased to announce that it has filed an amendment to the clinical protocol for its ongoing Phase I clinical trial of HG-CT-1 to include pediatric patients with relapsed/refractory acute myeloid leukemia ("R/R AML"). HG-CT-1 is the Company's CAR-T therapy, currently undergoing clinical trials in adults for the treatment of R/R AML.
This amendment, filed with the U.S. Food and Drug Administration (FDA), seeks to expand eligibility for the trial beyond adult patients to include children and adolescents with R/R AML, an aggressive disease with limited treatment options and poor prognosis in the relapsed/refractory setting. The expansion reflects the Company's commitment to broadening the potential impact of HG-CT-1 and addressing a critical unmet medical need in pediatric oncology.
The amendment builds on the Company's progress to date in the adult cohort of the trial, in which the first two patients have already been treated.
Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
"We are pleased to take this important step toward making HG-CT-1 available to pediatric patients who currently have very few therapeutic options. The inclusion of children and adolescents in the trial not only reflects our commitment to addressing urgent medical needs across age groups but also supports the broader potential of HG-CT-1 as a transformative therapy for AML."
Enquiries:
Hemogenyx Pharmaceuticals plc | |
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder | |
Peter Redmond, Director | |
SP Angel Corporate Finance LLP | Tel: +44 (0)20 3470 0470 |
Matthew Johnson, Vadim Alexandre, Adam Cowl | |
Peterhouse Capital Limited | Tel: +44 (0)20 7469 0930 |
Lucy Williams, Duncan Vasey, Charles Goodfellow |
About Hemogenyx Pharmaceuticals plc
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.
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SOURCE: Hemogenyx Pharmaceuticals PLC
View the original press release on ACCESS Newswire
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