Hemogenyx Pharmaceuticals PLC Announces Second Patient Treated with HG-CT-1 CAR-T Therapy
Hemogenyx Pharmaceuticals (LSE: HEMO) has announced the successful treatment of a second patient 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. This milestone follows the successful first-in-human treatment, which showed a favorable initial safety profile with no adverse effects. The Phase I trial is designed as a dose-escalation study to evaluate HG-CT-1's safety profile and collect data on secondary endpoints including anti-leukemic activity, survival rates, and duration of response. The company aims to potentially expand into pediatric trials following successful initial outcomes, addressing a significant unmet medical need in childhood AML treatment.
Hemogenyx Pharmaceuticals (LSE: HEMO) ha annunciato il trattamento con successo di un secondo paziente nella sua sperimentazione clinica di Fase I di HG-CT-1, una terapia cellulare CAR-T proprietaria rivolta alla leucemia mieloide acuta recidivante o refrattaria (R/R AML) negli adulti. Questo traguardo segue il primo trattamento umano riuscito, che ha evidenziato un profilo di sicurezza iniziale favorevole senza effetti avversi. Lo studio di Fase I è strutturato come uno studio di escalation di dose per valutare il profilo di sicurezza di HG-CT-1 e raccogliere dati su endpoint secondari, inclusa l'attività anti-leucemica, i tassi di sopravvivenza e la durata della risposta. L'azienda punta a espandere potenzialmente la sperimentazione anche ai pazienti pediatrici dopo i risultati iniziali positivi, affrontando un bisogno medico significativo nel trattamento della leucemia mieloide acuta infantile.
Hemogenyx Pharmaceuticals (LSE: HEMO) ha anunciado el tratamiento exitoso de un segundo paciente en su ensayo clínico de Fase I de HG-CT-1, una terapia celular CAR-T patentada dirigida a la leucemia mieloide aguda recidivante o refractaria (R/R AML) en adultos. Este logro sigue al primer tratamiento en humanos exitoso, que mostró un perfil inicial de seguridad favorable sin efectos adversos. El ensayo de Fase I está diseñado como un estudio de escalada de dosis para evaluar el perfil de seguridad de HG-CT-1 y recopilar datos sobre objetivos secundarios, incluyendo actividad anti-leucémica, tasas de supervivencia y duración de la respuesta. La compañía tiene como objetivo potencialmente ampliar los ensayos a población pediátrica tras resultados iniciales exitosos, abordando una necesidad médica importante en el tratamiento de la AML infantil.
Hemogenyx Pharmaceuticals (LSE: HEMO)는 성인 재발성 또는 불응성 급성 골수성 백혈병(R/R AML)을 표적으로 하는 독자적인 CAR-T 세포 치료제 HG-CT-1의 1상 임상시험에서 두 번째 환자 치료에 성공했다고 발표했습니다. 이 성과는 부작용 없는 우호적인 초기 안전성 프로필을 보였던 첫 인간 대상 치료 성공에 이은 것입니다. 1상 시험은 용량 증량 연구로 설계되어 HG-CT-1의 안전성 프로필을 평가하고 항백혈병 효과, 생존율, 반응 지속 기간 등 부차적 평가 항목에 대한 데이터를 수집합니다. 회사는 초기 성공적인 결과에 따라 소아 대상 임상시험으로 확장하는 것을 목표로 하여 소아 AML 치료에 있어 중요한 미충족 의료 수요를 해결하고자 합니다.
Hemogenyx Pharmaceuticals (LSE : HEMO) a annoncé le traitement réussi d'un deuxième patient dans son essai clinique de phase I de HG-CT-1, une thérapie cellulaire CAR-T propriétaire ciblant la leucémie myéloïde aiguë récidivante ou réfractaire (R/R LMA) chez l'adulte. Cette étape fait suite au premier traitement humain réussi, qui a montré un profil initial de sécurité favorable sans effets indésirables. L'essai de phase I est conçu comme une étude d'escalade de dose visant à évaluer le profil de sécurité de HG-CT-1 et à collecter des données sur des critères secondaires, notamment l'activité anti-leucémique, les taux de survie et la durée de la réponse. La société envisage potentiellement d'étendre les essais aux patients pédiatriques après des résultats initiaux positifs, répondant ainsi à un besoin médical important dans le traitement de la LMA infantile.
Hemogenyx Pharmaceuticals (LSE: HEMO) hat die erfolgreiche Behandlung eines zweiten Patienten in seiner Phase-I-Studie mit HG-CT-1, einer proprietären CAR-T-Zelltherapie gegen rezidivierte oder refraktäre akute myeloische Leukämie (R/R AML) bei Erwachsenen, bekannt gegeben. Dieser Meilenstein folgt auf die erfolgreiche Erstbehandlung am Menschen, die ein günstiges initiales Sicherheitsprofil ohne Nebenwirkungen zeigte. Die Phase-I-Studie ist als Dosis-Eskalationsstudie konzipiert, um das Sicherheitsprofil von HG-CT-1 zu bewerten und Daten zu sekundären Endpunkten wie antileukämischer Aktivität, Überlebensraten und Ansprechdauer zu sammeln. Das Unternehmen plant, nach erfolgreichen ersten Ergebnissen möglicherweise auch pädiatrische Studien durchzuführen, um einen bedeutenden ungedeckten medizinischen Bedarf bei der Behandlung von AML im Kindesalter zu adressieren.
- First patient treatment showed favorable safety profile with no adverse effects
- Successful progression to second patient treatment indicates steady clinical development
- Potential expansion into pediatric trials could address significant unmet medical needs
- Still in early Phase I trials with limited patient data
- Efficacy data and long-term safety profile yet to be established
LONDON, GB / ACCESS Newswire / May 2, 2025 / Hemogenyx Pharmaceuticals plc (LSE: HEMO) is pleased to announce that the second patient has been successfully treated as part of the Company's ongoing Phase I clinical trial of HG-CT-1, its proprietary CAR-T cell therapy for the treatment of relapsed or refractory acute myeloid leukemia ("R/R AML") in adults.
This milestone follows the successful first-in-human treatment with HG-CT-1, which demonstrated a favorable initial safety profile with no adverse effects observed, and the subsequent recruitment of the second patient. Together, these milestones mark steady progress in the clinical development of HG-CT-1 and reinforce the Company's commitment to advancing treatment options for patients with limited therapeutic alternatives.
The Phase I trial is a dose-escalation study designed to assess the safety profile of HG-CT-1 and to collect data on key secondary endpoints, including anti-leukemic activity, overall survival, progression-free survival, and duration of response.
The Company believes that continued clinical execution will not only advance a potentially transformative treatment for adult patients with limited therapeutic options but also generate long-term value for shareholders by establishing HG-CT-1 as a platform-defining asset in the field of hematologic malignancies. While the current trial is focused on adult patients, successful initial outcomes would pave the way for a pediatric trial - an area of significant unmet medical need in AML, where few effective treatment options exist for children.
Further updates on the clinical trial will be provided in due course.
Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
"The treatment of a second patient with HG-CT-1 marks another critical step in the development of our CAR-T therapy for relapsed or refractory AML. The ability to move forward with dosing reflects the capabilities of our scientific and manufacturing teams and further validates our platform. We remain deeply focused on executing the clinical program with rigor and care, and on our mission to bring potentially life-saving treatments to patients in need."
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 | |
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 diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as platform technologies that it uses as engines for novel product development.
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SOURCE: Hemogenyx Pharmaceuticals PLC
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