Hemogenyx Pharmaceuticals PLC - Third Patient Treated with HG-CT-1 CAR-T Therapy
Hemogenyx Pharmaceuticals (LSE:HEMO, OTC:HOPHF) has successfully treated the third patient in its Phase I clinical trial of HG-CT-1, a proprietary CAR-T cell therapy for relapsed/refractory acute myeloid leukemia (R/R AML). This marks the completion of the first adult dose cohort, achieved after receiving special FDA permission under exceptional circumstances.
The company reported encouraging early results, with the first two patients remaining alive at six and three months post-treatment. Following this milestone, Hemogenyx plans to advance to a second adult dose cohort with twice the initial dose and initiate a pediatric trial arm. The Phase I trial aims to evaluate safety and secondary endpoints including anti-leukemic activity, survival rates, and duration of response.
Hemogenyx Pharmaceuticals (LSE:HEMO, OTC:HOPHF) ha trattato con successo il terzo paziente nel trial di Fase I di HG-CT-1, la sua terapia CAR-T proprietaria per la leucemia mieloide acuta recidivante/refrattaria (R/R AML). Con questo trattamento si è completata la prima coorte di dose per adulti, autorizzata dalla FDA in circostanze eccezionali.
L'azienda ha riferito risultati preliminari incoraggianti: i primi due pazienti sono vivi a sei e tre mesi dal trattamento. Dopo questo traguardo, Hemogenyx intende passare a una seconda coorte adulta con il doppio della dose iniziale e avviare un braccio pediatrico dello studio. La Fase I valuterà la sicurezza e endpoint secondari come l'attività anti-leucemica, i tassi di sopravvivenza e la durata della risposta.
Hemogenyx Pharmaceuticals (LSE:HEMO, OTC:HOPHF) ha tratado con éxito al tercer paciente en su ensayo clínico de Fase I de HG-CT-1, su terapia CAR-T propietaria para la leucemia mieloide aguda en recaída/refractaria (R/R AML). Esto completa la primera cohorte de dosis en adultos, aprobada por la FDA en circunstancias excepcionales.
La compañía informó resultados iniciales prometedores: los dos primeros pacientes permanecen vivos a los seis y tres meses tras el tratamiento. Tras este hito, Hemogenyx planea avanzar a una segunda cohorte adulta con el doble de la dosis inicial e iniciar un brazo pediátrico del ensayo. La Fase I evaluará la seguridad y objetivos secundarios, incluidos la actividad anti‑leucémica, las tasas de supervivencia y la duración de la respuesta.
Hemogenyx Pharmaceuticals (LSE:HEMO, OTC:HOPHF)는 재발/불응성 급성 골수성 백혈병(R/R AML)을 위한 자사 CAR-T 치료제 HG-CT-1의 1상 임상시험에서 세 번째 환자에 대한 치료를 성공적으로 완료했습니다. 이번 치료로 성인 대상 1차 용량 코호트가 완료되었으며, 이는 FDA의 예외적 허가를 받아 이루어졌습니다.
회사는 초기 결과가 고무적이라고 보고했습니다. 첫 두 환자는 치료 후 각각 6개월과 3개월 시점에 생존해 있습니다. 이 성과에 따라 Hemogenyx는 초기 용량의 두 배에 해당하는 2차 성인 코호트로 진행하고 소아 대상 시험도 시작할 계획입니다. 1상 시험은 안전성 및 항백혈병 활성, 생존율, 반응 지속 기간 등 2차 평가변수를 조사하는 것을 목표로 합니다.
Hemogenyx Pharmaceuticals (LSE:HEMO, OTC:HOPHF) a traité avec succès le troisième patient dans son essai clinique de phase I de HG-CT-1, sa thérapie CAR‑T propriétaire pour la leucémie myéloïde aiguë en rechute/réfractaire (R/R AML). Cela marque l'achèvement de la première cohorte de dose chez l'adulte, obtenue grâce à une autorisation exceptionnelle de la FDA.
L'entreprise a rapporté des premiers résultats encourageants : les deux premiers patients sont vivants à six et trois mois après le traitement. Suite à cette étape, Hemogenyx prévoit de passer à une seconde cohorte adulte avec le double de la dose initiale et de lancer un volet pédiatrique. L'essai de phase I évaluera la sécurité et des critères secondaires tels que l'activité anti‑leucémique, les taux de survie et la durée de la réponse.
Hemogenyx Pharmaceuticals (LSE:HEMO, OTC:HOPHF) hat den dritten Patienten in der Phase‑I‑Studie von HG-CT-1, einer firmeneigenen CAR‑T‑Therapie für rezidivierende/refraktäre akute myeloische Leukämie (R/R AML), erfolgreich behandelt. Damit ist die erste Dosiskohorte für Erwachsene abgeschlossen, die unter außergewöhnlicher Genehmigung der FDA erfolgt ist.
Das Unternehmen meldete vielversprechende erste Ergebnisse: die ersten beiden Patienten leben noch sechs bzw. drei Monate nach der Behandlung. Nach diesem Meilenstein plant Hemogenyx den Übergang zu einer zweiten Erwachsenenkohorte mit der doppelten Anfangsdosis und die Aufnahme eines pädiatrischen Arms. Die Phase‑I‑Studie soll die Sicherheit sowie sekundäre Endpunkte wie antileukämische Aktivität, Überlebensraten und Dauer der Ansprechens bewerten.
- First two treated patients remain alive at 6 and 3 months post-treatment respectively
- Successful completion of first adult dose cohort in Phase I trial
- FDA granted special permission to proceed under exceptional circumstances
- Company cleared to advance to higher dose cohort and expand into pediatric trials
- Currently using lowest dose level in Phase I trial
- Dose-limiting toxicities still need to be evaluated before proceeding to higher doses
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
Third Patient Treated with HG-CT-1 CAR-T Therapy and Completion of First Adult Dose Cohort
LONDON, UNITED KINGDOM / ACCESS Newswire / August 15, 2025 / Hemogenyx Pharmaceuticals plc (LSE:HEMO) is pleased to announce that the third 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 relapsed or refractory acute myeloid leukemia ("R/R AML") in adults.
Treatment of this patient, the final participant in the first adult dose cohort, was made possible after the Company secured special permission from the U.S. Food and Drug Administration (FDA) to proceed under exceptional circumstances. This regulatory clearance reflects the Company's ability to navigate complex clinical challenges to ensure eligible patients can access potentially life-saving therapies.
Completion of the first adult dose cohort, which received the lowest dose of HG-CT-1, represents a pivotal milestone in the Company's trial. If no dose-limiting toxicities are observed, Hemogenyx Pharmaceuticals will:
Advance to the second adult dose cohort at twice the initial dose, and
Initiate recruitment for the pediatric arm of the trial, addressing a critical unmet need in childhood AML.
The Phase I trial is a dose-escalation study designed to assess safety and collect data on key secondary endpoints, including anti-leukemic activity, overall survival, progression-free survival, and duration of response. The Company is pleased to report that the first two patients treated with HG-CT-1 remain alive at six months and three months post-treatment, respectively.
Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
"Completing the first adult dose cohort is a major achievement in our Phase I trial of HG-CT-1. I am proud of our team's persistence in working with the FDA to obtain the necessary clearance to treat this patient. With this milestone reached, we are well positioned to move into the higher-dose cohort and to open our pediatric arm, advancing our mission to deliver transformative therapies for AML patients of all ages."
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.
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
View the original press release on ACCESS Newswire
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