Hemogenyx Pharmaceuticals PLC Announces Schedule for Phase I Clinical Trial Opening
Hemogenyx Pharmaceuticals has announced the schedule for opening its first clinical site for the Phase I trial of HEMO-CAR-T (HG-CT-1), targeting relapsed/refractory acute myeloid leukemia in adults. The company expects Institutional Review Board approval by mid-November, followed by a Site Initiation Visit in the third week. The trial will evaluate HG-CT-1's safety profile and assess secondary objectives including efficacy, overall survival rates, progression-free survival, and duration of response in patients with R/R AML who have therapeutic options.
Hemogenyx Pharmaceuticals ha annunciato il programma per l'apertura del suo primo sito clinico per la fase I della sperimentazione di HEMO-CAR-T (HG-CT-1), mirata alla leucemia mieloide acuta recidivante/resistente negli adulti. L'azienda prevede l'
Hemogenyx Pharmaceuticals ha anunciado el cronograma para la apertura de su primer sitio clínico para el ensayo de Fase I de HEMO-CAR-T (HG-CT-1), enfocado en la leucemia mieloide aguda en recaída/refractaria en adultos. La empresa espera la aprobación de la Junta de Revisión Institucional a mediados de noviembre, seguida de una Visita de Inicio de Sitio en la tercera semana. El ensayo evaluará el perfil de seguridad de HG-CT-1 y evaluará objetivos secundarios, incluyendo eficacia, tasas de supervivencia global, supervivencia libre de progresión y duración de la respuesta en pacientes con R/R AML que tienen opciones terapéuticas.
Hemogenyx Pharmaceuticals는 성인에서 재발성/불응성 급성 골수성 백혈병을 대상으로 하는 HEMO-CAR-T (HG-CT-1)의 1상 시험을 위한 첫 번째 임상 사이트 개설 일정을 발표했습니다. 회사는 11월 중순까지 기관 윤리 위원회의 승인를 기대하고 있으며, 그 주의 세 번째 주에 사이트 시작 방문이 있을 예정입니다. 이 시험은 HG-CT-1의 안전성을 평가하고 재발/불응성 AML 환자에서 치료 옵션을 가진 환자들의 효능, 전체 생존율, 무진행 생존 기간 및 반응 지속 시간을 포함한 2차 목표를 평가할 것입니다.
Hemogenyx Pharmaceuticals a annoncé le calendrier d'ouverture de son premier site clinique pour l'essai de phase I de HEMO-CAR-T (HG-CT-1), ciblant la leucémie aiguë myéloïde récidivante/résistante chez les adultes. La société prévoit l'approbation du Conseil d'examen institutionnel d'ici la mi-novembre, suivie d'une Visite d'Initiation de Site dans la troisième semaine. L'essai évaluera le profil de sécurité de HG-CT-1 et examinera les objectifs secondaires, y compris l'efficacité, les taux de survie globale, la survie sans progression et la durée de réponse chez les patients atteints de LAM R/R qui ont des options thérapeutiques.
Hemogenyx Pharmaceuticals hat den Zeitplan zur Eröffnung seiner ersten klinischen Stelle für die Phase-I-Studie von HEMO-CAR-T (HG-CT-1) angekündigt, die sich auf rezidivierende/refraktäre akute myeloische Leukämie bei Erwachsenen konzentriert. Das Unternehmen erwartet die Zulassung des Ethikkomitees bis Mitte November, gefolgt von einem Standortinitiierungsbesuch in der dritten Woche. Die Studie wird das Sicherheitsprofil von HG-CT-1 bewerten und sekundäre Zielvorgaben einschließlich Wirksamkeit, Gesamtüberlebensraten, progressionsfreies Überleben und Dauer der Reaktion bei Patienten mit R/R-AML, die über therapeutische Optionen verfügen, untersuchen.
- Phase I clinical trial for HG-CT-1 set to begin in November
- Successfully completed necessary contracts and budgeting preparations
- Trial to be conducted at one of world's most prestigious cancer research institutions
- None.
Hemogenyx Pharmaceuticals Announces Schedule for Opening First Clinical Site for Phase I Trial of HEMO-CAR-T (HG-CT-1)
LONDON, UK / ACCESSWIRE / October 30, 2024 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), a biopharmaceutical company focused on developing breakthrough therapies for blood diseases, is pleased to announce the schedule for the opening of the first clinical site for its lead asset, HEMO-CAR-T, formally designated HG-CT-1, targeting relapsed/refractory (R/R) acute myeloid leukemia (AML) in adults.
The Company has successfully completed the necessary contracts and budgeting preparations to advance HG-CT-1 into clinical testing. Institutional Review Board (IRB) approval at the initial clinical site is anticipated by the second week of November. Following IRB clearance, a Site Initiation Visit (SIV) is expected to take place in the third week of November, marking the official launch of the Phase I clinical trial.
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 will represent 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:
"Launching this Phase I clinical trial for HG-CT-1 will mark a critical step forward in our mission to develop transformative therapies for patients battling relapsed and refractory acute myeloid leukemia. For patients who have few remaining treatment options, HG-CT-1 offers a potentially life-saving solution. We are eager to initiate this trial and generate data that will be essential in advancing this therapy toward broader clinical use. This milestone underscores our commitment to innovation and our dedication to addressing the urgent needs of patients with severe blood cancers."
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.
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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