Hemogenyx Pharmaceuticals PLC Announces First Patient Safety
Hemogenyx Pharmaceuticals (LSE: HEMO) has announced successful initial safety results for the first patient treated in its Phase I clinical trial of HG-CT-1, a proprietary CAR-T cell therapy targeting relapsed or refractory acute myeloid leukemia (R/R AML) in adults.
The treatment demonstrated favorable tolerability with no adverse effects, meeting the primary safety assessment criteria. Early efficacy signs are reported as encouraging, with ongoing patient monitoring to evaluate secondary endpoints including:
- AML-specific response criteria assessment
- Overall survival evaluation
- Progression-free survival measurement
- Duration of response determination
The company is currently manufacturing HG-CT-1 for a second patient as part of this dose-escalation study, which aims to evaluate the therapy's potential in treating one of the most challenging forms of leukemia.
Hemogenyx Pharmaceuticals (LSE: HEMO) ha annunciato risultati iniziali di sicurezza positivi per il primo paziente trattato nel suo studio clinico di Fase I con HG-CT-1, una terapia cellulare CAR-T proprietaria mirata alla leucemia mieloide acuta recidivante o refrattaria (R/R AML) negli adulti.
Il trattamento ha dimostrato una tollerabilità favorevole senza effetti avversi, soddisfacendo i criteri principali di valutazione della sicurezza. I primi segni di efficacia sono stati riportati come incoraggianti, con un monitoraggio continuo dei pazienti per valutare gli endpoint secondari, tra cui:
- Valutazione dei criteri di risposta specifici per l'AML
- Valutazione della sopravvivenza complessiva
- Misurazione della sopravvivenza libera da progressione
- Determinazione della durata della risposta
L'azienda sta attualmente producendo HG-CT-1 per un secondo paziente come parte di questo studio di escalation della dose, che mira a valutare il potenziale della terapia nel trattamento di una delle forme di leucemia più difficili.
Hemogenyx Pharmaceuticals (LSE: HEMO) ha anunciado resultados iniciales de seguridad exitosos para el primer paciente tratado en su ensayo clínico de Fase I con HG-CT-1, una terapia celular CAR-T propietaria dirigida a la leucemia mieloide aguda recidivante o refractaria (R/R AML) en adultos.
El tratamiento demostró una tolerabilidad favorable sin efectos adversos, cumpliendo con los criterios de evaluación de seguridad primaria. Se informan signos tempranos de eficacia como alentadores, con un monitoreo continuo de los pacientes para evaluar los puntos finales secundarios, que incluyen:
- Evaluación de criterios de respuesta específicos para la AML
- Evaluación de la supervivencia general
- Medición de la supervivencia libre de progresión
- Determinación de la duración de la respuesta
La empresa está actualmente fabricando HG-CT-1 para un segundo paciente como parte de este estudio de escalada de dosis, que tiene como objetivo evaluar el potencial de la terapia en el tratamiento de una de las formas más desafiantes de leucemia.
Hemogenyx Pharmaceuticals (LSE: HEMO)는 성인의 재발성 또는 난치성 급성 골수성 백혈병(R/R AML)을 목표로 하는 독점 CAR-T 세포 요법인 HG-CT-1의 1상 임상 시험에서 첫 번째 환자에 대한 초기 안전성 결과가 성공적이었다고 발표했습니다.
이 치료는 부작용 없이 우호적인 내약성을 보였으며, 주요 안전성 평가 기준을 충족했습니다. 조기 유효성 징후는 고무적이라고 보고되었으며, 환자 모니터링이 계속 진행되어 다음과 같은 이차적 평가 기준을 평가하고 있습니다:
- AML 특정 반응 기준 평가
- 전체 생존 평가
- 진행 없는 생존 측정
- 반응 지속 기간 결정
회사는 현재 이 용량 증가 연구의 일환으로 두 번째 환자를 위한 HG-CT-1을 제조하고 있으며, 이는 가장 도전적인 형태의 백혈병 치료에서 요법의 잠재력을 평가하는 것을 목표로 하고 있습니다.
Hemogenyx Pharmaceuticals (LSE: HEMO) a annoncé des résultats initiaux de sécurité positifs pour le premier patient traité dans son essai clinique de Phase I avec HG-CT-1, une thérapie cellulaire CAR-T propriétaire ciblant la leucémie myéloïde aiguë récurrente ou réfractaire (R/R AML) chez les adultes.
Le traitement a montré une tolérance favorable sans effets indésirables, répondant aux critères d'évaluation de sécurité principaux. Des signes précoces d'efficacité sont rapportés comme encourageants, avec une surveillance continue des patients pour évaluer les critères d'évaluation secondaires, notamment :
- Évaluation des critères de réponse spécifiques à l'AML
- Évaluation de la survie globale
- Mesure de la survie sans progression
- Détermination de la durée de la réponse
L'entreprise fabrique actuellement HG-CT-1 pour un deuxième patient dans le cadre de cette étude d'escalade de dose, qui vise à évaluer le potentiel de la thérapie dans le traitement de l'une des formes de leucémie les plus difficiles.
Hemogenyx Pharmaceuticals (LSE: HEMO) hat positive erste Sicherheitsresultate für den ersten Patienten bekannt gegeben, der in seiner klinischen Phase-I-Studie mit HG-CT-1 behandelt wurde, einer proprietären CAR-T-Zelltherapie, die auf rezidivierende oder refraktäre akute myeloische Leukämie (R/R AML) bei Erwachsenen abzielt.
Die Behandlung zeigte eine günstige Verträglichkeit ohne Nebenwirkungen und erfüllte die primären Sicherheitsbewertungskriterien. Erste Anzeichen für die Wirksamkeit werden als ermutigend berichtet, während die Patienten weiterhin überwacht werden, um sekundäre Endpunkte zu bewerten, darunter:
- Bewertung der AML-spezifischen Ansprechkriterien
- Bewertung der Gesamtüberlebensrate
- Messung der progressionsfreien Überlebenszeit
- Bestimmung der Ansprechdauer
Das Unternehmen stellt derzeit HG-CT-1 für einen zweiten Patienten im Rahmen dieser Dosissteigerungsstudie her, die darauf abzielt, das Potenzial der Therapie zur Behandlung einer der herausforderndsten Formen von Leukämie zu bewerten.
- Successful completion of initial safety assessment with no adverse effects
- Early signs of efficacy reported as encouraging
- Manufacturing process advancing for second patient treatment
- Clinical trial progressing as planned with FDA-approved protocol
- Early-stage trial with patient data (only one patient treated)
- Long-term efficacy and safety data still pending
- Secondary endpoints results not yet available
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU WHICH IS PART OF DOMESTIC UK LAW PURSUANT TO THE MARKET ABUSE (AMENDMENT) (EU EXIT) REGULATIIONS (SI 2019/310) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.
24 March 2025
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
First Patient Treated with HG-CT-1 CAR-T Therapy Passes Initial Safety Tests
LONDON, UNITED KINGDOM / ACCESS Newswire / March 24, 2025 / Hemogenyx Pharmaceuticals plc is pleased to announce that the first patient has been successfully treated as part of the Company's Phase I clinical trial of HG-CT-1, the Company's proprietary CAR-T cell therapy for relapsed or refractory acute myeloid leukemia (R/R AML) in adults. The treatment was well tolerated, with no adverse effects observed, thereby passing the initial safety assessment.
Early signs of efficacy are encouraging. The patient will continue to be monitored in accordance with the FDA-approved clinical protocol to evaluate whether the secondary endpoints of the trial are achieved.
Manufacturing of HG-CT-1 is currently underway for the treatment of a second patient.
This Phase I clinical trial is a dose-escalation study designed to evaluate the safety profile of HG-CT-1 in adult patients with R/R AML. In addition to safety, key secondary objectives of the trial include:
Assessing the efficacy of HG-CT-1 based on AML-specific response criteria
Evaluating overall survival
Measuring progression-free survival
Determining duration of response in patients demonstrating clinical benefit
Data related to these secondary endpoints, including efficacy, durability, and overall clinical outcomes, will be collected over time through continued follow-up of the treated patient. These secondary endpoints are critical for assessing the potential clinical impact of HG-CT-1 in a patient population with limited remaining treatment options.
Further updates on the clinical trial will be provided in due course.
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
"The successful treatment of the first patient with HG-CT-1 marks a major milestone not only for Hemogenyx Pharmaceuticals but also for patients battling relapsed or refractory AML. We are encouraged by the favorable safety profile observed so far and the early signs of efficacy. This outcome strengthens our confidence in the potential of HG-CT-1 to address one of the most challenging and deadly forms of leukemia. We remain committed to advancing this therapy through clinical development with the goal of delivering a transformative treatment to patients in desperate needwhile creating long-term value for our shareholders."
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.
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 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.
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
SOURCE: Hemogenyx Pharmaceuticals PLC
View the original press release on ACCESS Newswire
FAQ
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