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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.
Positive
- 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
Negative
- Currently using lowest dose level in Phase I trial
- Dose-limiting toxicities still need to be evaluated before proceeding to higher doses
08/15/2025 – 02:00 AM
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), a biotech firm specializing in innovative blood disease therapies, announced a significant milestone today. The company confirmed the successful treatment of the third patient in its Phase I clinical trial for HG-CT-1, a proprietary CAR-T cell therapy designed to combat relapsed or refractory acute myeloid leukemia (R/R AML) in adults. This marks the completion of the trial’s first adult dose cohort.
The FDA granted Hemogenyx special permission to proceed under “exceptional circumstances,” a move that underscores the urgency and potential of the therapy for patients with limited treatment options. According to Hemogenyx, this regulatory flexibility highlights the company’s ability to navigate the complexities of clinical trials, ensuring that eligible patients gain access to potentially life-saving treatments.
Completion of the first adult dose cohort, which utilized the lowest dose of HG-CT-1, is considered a pivotal step in the Phase I trial. The company is now poised to escalate the dosage. Subject to the observation of no dose-limiting toxicities, Hemogenyx Pharmaceuticals will push forward on two key fronts:
- Initiating the second adult dose cohort, doubling the initial dosage to further assess efficacy.
- Commencing recruitment for the pediatric arm of the trial, addressing a critical unmet need in the treatment of childhood AML. This expansion into pediatric trials represents a significant step towards broadening the potential impact of HG-CT-1.
The ongoing Phase I trial employs a dose-escalation design. Its primary objective is to rigorously evaluate the safety profile of HG-CT-1. Simultaneously, researchers are gathering data on critical secondary endpoints, including anti-leukemic activity, overall survival rates, progression-free survival, and the duration of patient response. Adding to the positive momentum, Hemogenyx reports that the first two adult patients treated with HG-CT-1 have remained alive six months and three months post-treatment, respectively.
Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, conveyed confidence in the advancement of the therapy. “Completing the first adult dose cohort is a major achievement in our Phase I trial of HG-CT-1,” Dr. Sandler stated. “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.” Hemogenyx’s ability to reach younger patients will be a game changer for the company’s future.
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:
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.
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 or visit www.rns.com.
SOURCE: Hemogenyx Pharmaceuticals PLC
View the original press release on ACCESS Newswire
FAQ
What are the latest results from Hemogenyx’s (HOPHF) HG-CT-1 CAR-T therapy trial?
Hemogenyx has successfully treated the third patient in its Phase I trial, completing the first adult dose cohort. The first two patients treated remain alive at 6 and 3 months post-treatment respectively.
What is the purpose of Hemogenyx’s HG-CT-1 CAR-T cell therapy?
HG-CT-1 is being developed to treat relapsed or refractory acute myeloid leukemia (R/R AML) in both adult and pediatric patients.
What are the next steps for Hemogenyx’s (HOPHF) Phase I trial?
Pending no dose-limiting toxicities, Hemogenyx will advance to a second adult dose cohort with twice the initial dose and initiate recruitment for the pediatric trial arm.
What endpoints is Hemogenyx measuring in the HG-CT-1 Phase I trial?
The trial is measuring safety as primary endpoint, with secondary endpoints including anti-leukemic activity, overall survival, progression-free survival, and duration of response.
How did Hemogenyx obtain approval to treat the third patient in the HG-CT-1 trial?
Hemogenyx secured special permission from the FDA to proceed under exceptional circumstances, demonstrating their ability to navigate complex clinical challenges.
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