Hemogenyx Pharmaceuticals PLC Announces Site Initiation Visit Completed
Hemogenyx Pharmaceuticals has successfully completed the Site Initiation Visit for its Phase I clinical trial of HG-CT-1 (HEMO-CAR-T) at the first clinical site. The trial is designed as a dose escalation study to evaluate the safety of HG-CT-1 in adult patients with relapsed/refractory (R/R) acute myeloid leukaemia (AML).
Patient recruitment will commence once the clinical site provides final details to the company's clinical trials manager, Prevail Infoworks. This milestone represents a significant advancement for the company's lead asset, demonstrating their commitment to developing innovative therapies for R/R AML patients who currently have treatment options.
Hemogenyx Pharmaceuticals ha completato con successo la Visita di Inizio Sito per il suo trial clinico di Fase I di HG-CT-1 (HEMO-CAR-T) presso il primo sito clinico. Lo studio è progettato come uno studio di escalation della dose per valutare la sicurezza di HG-CT-1 in pazienti adulti con leucemia mieloide acuta (AML) in recidiva/refrattaria (R/R).
Il reclutamento dei pazienti inizierà non appena il sito clinico fornirà i dettagli finali al responsabile delle sperimentazioni cliniche dell'azienda, Prevail Infoworks. Questo traguardo rappresenta un avanzamento significativo per l'asset principale dell'azienda, dimostrando il loro impegno nello sviluppo di terapie innovative per i pazienti con AML R/R che attualmente hanno opzioni di trattamento limitate.
Hemogenyx Pharmaceuticals ha completado con éxito la Visita de Inicio de Sitio para su ensayo clínico de Fase I de HG-CT-1 (HEMO-CAR-T) en el primer sitio clínico. El ensayo está diseñado como un estudio de escalación de dosis para evaluar la seguridad de HG-CT-1 en pacientes adultos con leucemia mieloide aguda (LMA) en recaída/refractaria (R/R).
El reclutamiento de pacientes comenzará una vez que el sitio clínico proporcione los detalles finales al gerente de ensayos clínicos de la empresa, Prevail Infoworks. Este hito representa un avance significativo para el activo principal de la empresa, demostrando su compromiso de desarrollar terapias innovadoras para los pacientes con LMA R/R que actualmente tienen opciones de tratamiento limitadas.
Hemogenyx Pharmaceuticals는 첫 번째 임상 사이트에서 HG-CT-1 (HEMO-CAR-T)의 1상 임상 시험을 위한 사이트 시작 방문을 성공리에 완료했습니다. 이 시험은 재발성/불응성(R/R) 급성 골수성 백혈병(AML) 성인 환자의 HG-CT-1 안전성을 평가하기 위해 용량 증량 연구로 설계되었습니다.
환자 모집은 임상 사이트가 회사의 임상 시험 관리자 인 Prevail Infoworks에 최종 세부 정보를 제공하는 즉시 시작될 것입니다. 이 이정표는 회사의 주요 자산에 대한 중요한 발전을 나타내며, 현재 치료 옵션이 없는 R/R AML 환자를 위한 혁신적인 치료법 개발에 대한 헌신을 보여줍니다.
Hemogenyx Pharmaceuticals a réussi à finaliser la Visite d'Initiation de Site pour son essai clinique de Phase I de HG-CT-1 (HEMO-CAR-T) au premier site clinique. L'essai est conçu comme une étude d'escalade de dose pour évaluer la sécurité de HG-CT-1 chez des patients adultes atteints de leucémie myéloïde aiguë (LMA) récidivante/réfractaire (R/R).
Le recrutement des patients commencera une fois que le site clinique aura fourni les détails finaux au responsable des essais cliniques de l'entreprise, Prevail Infoworks. Ce jalon représente une avancée significative pour l'actif principal de l'entreprise, démontrant son engagement à développer des thérapies innovantes pour les patients atteints de LMA R/R qui disposent actuellement d'options de traitement limitées.
Hemogenyx Pharmaceuticals hat erfolgreich den Standortinitierungsbesuch für seine Phase-I-Studie zu HG-CT-1 (HEMO-CAR-T) am ersten klinischen Standort abgeschlossen. Die Studie ist als Dosissteigerungsstudie konzipiert, um die Sicherheit von HG-CT-1 bei erwachsenen Patienten mit rezidivierter/refraktärer (R/R) akuter myeloischer Leukämie (AML) zu bewerten.
Die Patientenwerbung beginnt, sobald der klinische Standort die endgültigen Details an den klinischen Studienmanager des Unternehmens, Prevail Infoworks, übermittelt. Dieser Meilenstein stellt einen bedeutenden Fortschritt für das führende Vermögen des Unternehmens dar und zeigt ihr Engagement für die Entwicklung innovativer Therapien für R/R-AML-Patienten, die derzeit über begrenzte Behandlungsoptionen verfügen.
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Hemogenyx Pharmaceuticals Successfully Completes the Site Initiation Visit of the First Clinical Site for Phase I Clinical Trial of HG-CT-1
LONDON, UNITED KINGDOM / ACCESSWIRE / December 9, 2024 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical company developing innovative therapies for blood diseases, is pleased to announce the successful completion of the Site Initiation Visit at the first clinical site for its Phase I clinical trial of HG-CT-1 (also known as HEMO-CAR-T). The Phase I clinical trial is designed as a dose escalation study to assess the safety of HG-CT-1 in adult patients with relapsed/refractory (R/R) acute myeloid leukaemia (AML).
Patient recruitment will begin once the clinical site provides final details to the Company's clinical trials manager, Prevail Infoworks.
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
"This step marks a significant milestone for the Company as we advance our lead asset,HG-CT-1, into clinical trials. This study represents our commitment to developing innovative therapies for patients with R/R AML, a condition with limited treatment options.
We are excited to see patient recruitment set to begin and take the next steps in assessing the safety and treatment potential of HEMO-CAR-T. We remain dedicated to delivering transformative therapies that address critical unmet medical needs."
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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