Hemogenyx Pharmaceuticals PLC Announces IRB Approval for Phase I Clinical Trial
Hemogenyx Pharmaceuticals has received Institutional Review Board (IRB) approval to initiate a Phase I clinical trial of HEMO-CAR-T (HG-CT-1) for treating relapsed/refractory acute myeloid leukemia (R/R AML) in adults. The trial is designed as a dose escalation study to assess safety, with secondary objectives including efficacy evaluation, overall survival, progression-free survival, and duration of response in patients. This approval marks a significant milestone for the company, allowing clinical testing at a prestigious cancer research institution.
Hemogenyx Pharmaceuticals ha ricevuto l'approvazione dal Comitato Etico (IRB) per avviare un studio clinico di Fase I di HEMO-CAR-T (HG-CT-1) per il trattamento della leucemia mieloide acuta recidivante/refrattaria (R/R AML) negli adulti. Lo studio è progettato come uno studio di escalation della dose per valutare la sicurezza, con obiettivi secondari che includono la valutazione dell'efficacia, la sopravvivenza complessiva, la sopravvivenza libera da progressione e la durata della risposta nei pazienti. Questa approvazione segna una tappa significativa per l'azienda, consentendo test clinici presso un prestigioso istituto di ricerca sul cancro.
Hemogenyx Pharmaceuticals ha recibido la aprobación de la Junta de Revisión Institucional (IRB) para iniciar un ensayo clínico de Fase I de HEMO-CAR-T (HG-CT-1) para el tratamiento de la leucemia mieloide aguda recidivante/refractaria (R/R AML) en adultos. El ensayo está diseñado como un estudio de escalada de dosis para evaluar la seguridad, con objetivos secundarios que incluyen la evaluación de la eficacia, la supervivencia general, la supervivencia libre de progresión y la duración de la respuesta en los pacientes. Esta aprobación marca un hito significativo para la empresa, permitiendo pruebas clínicas en una prestigiosa institución de investigación del cáncer.
Hemogenyx Pharmaceuticals는 성인의 재발/불응성 급성 골수성 백혈병(R/R AML) 치료를 위한 HEMO-CAR-T (HG-CT-1)의 1상 임상 시험을 시작하기 위해 기관생명윤리위원회(IRB)의 승인을 받았습니다. 이 시험은 안전성을 평가하기 위한 용량 증량 연구로 설계되었으며, 2차 목표는 환자의 효능 평가, 전체 생존율, 무진행 생존율 및 반응 기간을 포함합니다. 이번 승인은 회사에 중요한 이정표가 되며, 권위 있는 암 연구 기관에서 임상 테스트를 수행할 수 있게 되었습니다.
Hemogenyx Pharmaceuticals a reçu l'approbation du Comité d'éthique institutionnel (IRB) pour initier un essai clinique de Phase I de HEMO-CAR-T (HG-CT-1) pour le traitement de la leucémie myéloïde aiguë récurrente/réfractaire (R/R AML) chez les adultes. L'essai est conçu comme une étude d'escalade de dose pour évaluer la sécurité, avec des objectifs secondaires incluant l'évaluation de l'efficacité, la survie globale, la survie sans progression et la durée de la réponse chez les patients. Cette approbation marque une étape importante pour l'entreprise, permettant des tests cliniques dans une prestigieuse institution de recherche sur le cancer.
Hemogenyx Pharmaceuticals hat die Genehmigung der Ethikkommission (IRB) erhalten, um eine Phase-I-Studie zu HEMO-CAR-T (HG-CT-1) zur Behandlung von rückfälliger/restistenter akuter myeloischer Leukämie (R/R AML) bei Erwachsenen zu beginnen. Die Studie ist als Dosis-Eskalationsstudie konzipiert, um die Sicherheit zu bewerten, während die sekundären Ziele die Evaluierung der Wirksamkeit, die Gesamtüberlebensrate, die progressionfreie Überlebenszeit und die Dauer der Ansprechrate bei Patienten umfassen. Diese Genehmigung stellt einen bedeutenden Meilenstein für das Unternehmen dar und ermöglicht klinische Tests an einer renommierten Krebsforschungsinstitution.
- Received IRB approval to begin Phase I clinical trial
- Trial targets R/R AML patients, representing an unmet medical need
- Comprehensive trial design including multiple efficacy endpoints
- Early-stage Phase I trial with focus only on safety, efficacy as secondary endpoint
- No guaranteed timeline for trial completion or results
Hemogenyx Pharmaceuticals Receives IRB Approval for Phase 1 Clinical Trial of HEMO-CAR-T (HG-CT-1)
LONDON, UK / ACCESSWIRE / November 22, 2024 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), a biopharmaceutical company developing innovative therapies and treatments for blood diseases, is pleased to announce that the Institutional Review Board (IRB)of the Company's first clinical site has granted approval to initiate a Phase I clinical trial of the Company's lead asset, HEMO-CAR-T, which has now been given the formal designation HG-CT-1, for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML) in adults.
The proposed Phase 1 clinical trial is designed as a dose escalation study to assess the safety of HG-CT-1 in adult patients with R/R AML. Secondary clinical objectives are crucial for evaluating the broader impact of HG-CT-1 and include:
Estimating the efficacyof HG-CT-1 based on standard clinical response criteria for AML.
Estimating overall survival (OS)in evaluable subjects.
Estimating progression-free survival (PFS)in evaluable subjects.
Estimating duration of response (DoR)in evaluable subjects who achieve a clinical response.
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. This IRB approval represents a significant 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:
"We are excited to receive IRB approval to proceed with our PhaseI clinical trial of HEMO-CAR-T. This trial is a critical step in the development of our CAR-T therapy for AML patients who have exhausted other treatment options. With this study, we aim to establish the safety profile of HG-CT-1 and gather preliminary efficacy data that could pave the way for future therapeutic development."
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
What is the purpose of Hemogenyx's Phase I trial for HG-CT-1?
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What milestone has Hemogenyx (HOPHF) achieved for its HEMO-CAR-T therapy?
