Hemogenyx Pharmaceuticals PLC Announces Opening of First Clinical Site
Hemogenyx Pharmaceuticals (LSE:HEMO) has announced the opening of its first clinical site for the Phase I trial of HG-CT-1, targeting relapsed/refractory (R/R) acute myeloid leukemia (AML) in adults. Patient recruitment has commenced for this dose-escalation study, which aims to evaluate the safety profile of the CAR-T cell therapy.
The trial's secondary objectives include assessing efficacy based on AML-specific response criteria, overall survival rates, progression-free survival, and duration of response in patients who achieve clinical responses. This development represents a significant milestone for the company in advancing its therapy into clinical testing at a leading cancer research institution.
Hemogenyx Pharmaceuticals (LSE:HEMO) ha annunciato l'apertura del suo primo sito clinico per la fase I della sperimentazione di HG-CT-1, mirata a leucemia mieloide acuta (LMA) in adulti con recidiva/refrattarietà (R/R). È iniziato il reclutamento dei pazienti per questo studio di dose-escalation, che mira a valutare il profilo di sicurezza della terapia con cellule CAR-T.
Gli obiettivi secondari della sperimentazione includono la valutazione dell'efficacia basata su criteri di risposta specifici per LMA, tassi di sopravvivenza globale, sopravvivenza libera da progressione e durata della risposta nei pazienti che ottengono risposte cliniche. Questo sviluppo rappresenta un importante traguardo per l'azienda nell'avanzare la sua terapia nella sperimentazione clinica presso un'importante istituzione di ricerca sul cancro.
Hemogenyx Pharmaceuticals (LSE:HEMO) ha anunciado la apertura de su primer sitio clínico para el ensayo de fase I de HG-CT-1, que tiene como objetivo la leucemia mieloide aguda (LMA) en adultos con recaídas/refractariedad (R/R). Ha comenzado el reclutamiento de pacientes para este estudio de escalado de dosis, que busca evaluar el perfil de seguridad de la terapia con células CAR-T.
Los objetivos secundarios del ensayo incluyen evaluar la eficacia basada en criterios de respuesta específicos de LMA, tasas de supervivencia general, supervivencia libre de progresión y duración de la respuesta en pacientes que logran respuestas clínicas. Este desarrollo representa un hito importante para la empresa en el avance de su terapia hacia las pruebas clínicas en una destacada institución de investigación del cáncer.
Hemogenyx Pharmaceuticals (LSE:HEMO)는 성인에서 재발/불응(리프랙터리) 급성 골수성 백혈병(AML)을 대상으로 하는 HG-CT-1의 1상 시험을 위한 첫 번째 임상 사이트 개설을 발표했습니다. 이 용량 증량 연구를 위해 환자 모집이 시작되었으며, CAR-T 세포 요법의 안전성 프로파일을 평가하는 것을 목표로 하고 있습니다.
시험의 2차 목표는 AML 특정 반응 기준에 따른 효능 평가, 전체 생존율, 무진행 생존, 임상 반응을 보인 환자의 반응 지속 기간 포함됩니다. 이 개발은 기업이 주요 암 연구 기관에서 임상 시험으로 치료법을 발전시키는 데 중요한 이정표를 나타냅니다.
Hemogenyx Pharmaceuticals (LSE:HEMO) a annoncé l'ouverture de son premier site clinique pour l'essai de phase I de HG-CT-1, visant la leucémie myéloïde aiguë (LMA) récurrente/réfractaire (R/R) chez les adultes. Le recrutement des patients a commencé pour cette étude d'escalade de dose, qui vise à évaluer le profil de sécurité de la thérapie par cellules CAR-T.
Les objectifs secondaires de l'essai comprennent l'évaluation de l'efficacité basée sur des critères de réponse spécifiques à la LMA, des taux de survie globale, de survie sans progression et de durée de réponse chez les patients ayant obtenu des réponses cliniques. Ce développement représente une étape importante pour l'entreprise dans l'avancement de sa thérapie vers des essais cliniques dans une institution de recherche sur le cancer de premier plan.
Hemogenyx Pharmaceuticals (LSE:HEMO) hat die Eröffnung ihrer ersten klinischen Stelle für die Phase-I-Studie von HG-CT-1 bekannt gegeben, die auf rückfällige/refraktäre (R/R) akute myeloische Leukämie (AML) bei Erwachsenen abzielt. Die Rekrutierung von Patienten für diese Dosis-Eskalationsstudie hat begonnen, die darauf abzielt, das Sicherheitsprofil der CAR-T-Zelltherapie zu bewerten.
Die sekundären Ziele der Studie umfassen die Bewertung der Wirksamkeit basierend auf AML-spezifischen Antwortkriterien, der Gesamtüberlebensraten, der progressionsfreien Überlebenszeit und der Dauer der Reaktion bei Patienten, die klinische Reaktionen zeigen. Diese Entwicklung stellt einen bedeutenden Meilenstein für das Unternehmen dar, um seine Therapie in die klinische Prüfung an einer führenden Krebsforschungseinrichtung voranzubringen.
- Initiation of Phase I clinical trial for lead asset HG-CT-1
- Patient recruitment has begun
- Trial conducted at prestigious cancer research institution
- None.
Hemogenyx Pharmaceuticals Opens First Clinical Site for HG-CT-1 Phase I Trial
Patient Recruitment Begins for CAR-T Cell Therapy Targeting Relapsed/Refractory Acute Myeloid Leukemia in Adults
LONDON, UK / ACCESSWIRE / December 30, 2024 / Hemogenyx Pharmaceuticals plc ("Hemogenyx Pharmaceuticals" or the "Company")(LSE:HEMO) is pleased to announce the opening of the first clinical site for its lead asset, HG-CT-1, targeting relapsed/refractory (R/R) acute myeloid leukemia (AML) in adults. Recruitment of patients for the trials has begun.
This Phase I trial is designed as a dose-escalation study to evaluate the safety profile of HG-CT-1 in adult patients with R/R AML. Key secondary objectives include assessing the therapy's impact on the following clinical outcomes:
Efficacy of HG-CT-1 based on AML-specific response criteria
Overall survival (OS) rates among participating subjects
Progression-free survival (PFS) in evaluable subjects
Duration of response (DoR) in those who achieve clinical responses.
These objectives are pivotal for assessing the overall clinical impact of HG-CT-1 on patients with R/R AML, a population with few remaining therapeutic options. The commencement of this trial represents a major milestone for Hemogenyx Pharmaceuticals, enabling the Company to advance this promising therapy into clinical testing at one of the world's most prestigious cancer research institutions.
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
" The opening of our first clinical site for the Phase I trial of HG-CT-1 is a milestone in our mission to revolutionize the treatment landscape for relapsed and refractory acute myeloid leukemia. This trial offers hope to patients who currently face limited treatment options by exploring the safety and potential efficacy of HG-CT-1. We are excited to start this pivotal study."
About AML and CAR-T Therapy
AML, the most common type of acute leukemia in adults, has poor survival rates (a five-year survival rate of less than
CAR-T therapy is a treatment in which a patient's own T-cells, a type of immune cell, are modified to recognize and kill the patient's cancer cells. The procedure involves: isolating T-cells from the patient; modifying the isolated T-cells in a laboratory using a CAR gene construct (which allows the cells to recognize the patient's cancer); amplifying (growing to large numbers) the newly modified cells; and re-introducing the cells back into the patient.
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 | |
Peter Redmond, Director | |
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SP Angel Corporate Finance LLP | Tel: +44 (0)20 3470 0470 |
Matthew Johnson, Vadim Alexandre, Adam Cowl |
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Peterhouse Capital Limited | Tel: +44 (0)20 7469 0930 |
Lucy Williams, Duncan Vasey, Charles Goodfellow |
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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 disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as a platform technology that it uses as an engine for novel product development.
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SOURCE: Hemogenyx Pharmaceuticals PLC
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FAQ
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