Hemogenyx Pharmaceuticals PLC Announces Clearance to Initiate Pediatric Enrolment
Hemogenyx Pharmaceuticals (HOPHF) announced on October 6, 2025 that the Institutional Review Board at MD Anderson Cancer Center approved an amendment to its Phase I HG-CT-1 clinical protocol to include children and adolescents with relapsed or refractory acute myeloid leukemia (R/R AML).
The PR states this expansion builds on safety and early efficacy signals observed in adult participants and allows the company to begin pediatric enrolment in the HG-CT-1 trial; the company says it will provide further updates as adult and pediatric enrolment progresses.
Hemogenyx Pharmaceuticals (HOPHF) ha annunciato il 6 ottobre 2025 che il Comitato Istituzionale di Revisione presso il MD Anderson Cancer Center ha approvato un emendamento al protocollo clinico di fase I HG-CT-1 per includere bambini e adolescenti con leucemia mieloide acuta recidivante o refrattaria (R/R AML).
Il comunicato stampa afferma che questa espansione si basa su segnali di sicurezza ed efficacia iniziali osservati nei partecipanti adulti e permette all'azienda di avviare l'arruolamento pediatrico nello studio HG-CT-1; l'azienda afferma che fornirà ulteriori aggiornamenti man mano che procede l'arruolamento di adulti e pediatrici.
Hemogenyx Pharmaceuticals (HOPHF) anunció el 6 de octubre de 2025 que la Junta de Revisión Institucional del MD Anderson Cancer Center aprobó una enmienda al protocolo clínico de fase I HG-CT-1 para incluir niños y adolescentes con leucemia mieloide aguda recidivante o refractaria (R/R AML).
El comunicado indica que esta expansión se apoya en señales de seguridad y eficacia temprana observadas en participantes adultos y permite a la empresa comenzar el reclutamiento pediátrico en el ensayo HG-CT-1; la empresa dice que proporcionará más actualizaciones a medida que avance el reclutamiento de adultos y pediátricos.
Hemogenyx Pharmaceuticals (HOPHF)가 2025년 10월 6일에 MD 앤더슨 암 센터(MD Anderson Cancer Center)의 기관 심의위원회가 HG-CT-1 임상 1상 프로토콜의 수정안을 승인하여 소아 및 청소년을 포함하도록 허용했습니다. 재발 또는 불응성 급성 골수성 백혈병(R/R AML)을 가진 환자에 한합니다.
PR에 따르면 이 확장은 성인 참가자에서 관찰된 안전성 및 초기 효능 신호를 기반으로 하며 HG-CT-1 시험의 소아 모집을 시작할 수 있게 합니다. 회사는 성인 및 소아 모집이 진행됨에 따라 추가 업데이트를 제공할 것이라고 말했습니다.
Hemogenyx Pharmaceuticals (HOPHF) a annoncé le 6 octobre 2025 que le Comité d'éthique institutionnel du MD Anderson Cancer Center a approuvé un amendement au protocole clinique de phase I HG-CT-1 afin de inclure les enfants et les adolescents atteints de leucémie myéloïde aiguë réurrente ou réfractaire (R/R AML).
Le communiqué précise que cette expansion s'appuie sur les signaux de sécurité et d'efficacité précoce observés chez les participants adultes et permet à l'entreprise de lancer l'enrôlement pédiatrique dans l'essai HG-CT-1; l'entreprise indique qu'elle fournira d'autres mises à jour à mesure que l'enrôlement adulte et pédiatrique progressa.
Hemogenyx Pharmaceuticals (HOPHF) hat am 6. Oktober 2025 dem Institutional Review Board des MD Anderson Cancer Center eine Änderung des Phase-I-Studienprotokolls HG-CT-1 genehmigt, um Kinder und Jugendliche mit rezidivierender oder refraktärer akuter myeloischer Leukämie (R/R AML) einzuschließen.
Die Mitteilung besagt, dass diese Erweiterung auf Sicherheits- und frühen Wirksamkeitssignalen basiert, die bei erwachsenen Teilnehmern beobachtet wurden, und es dem Unternehmen ermöglicht, die pädiatrische Einschreibung in die HG-CT-1-Studie zu beginnen; das Unternehmen erklärt, dass weitere Updates folgen, sobald die Einschreibung von Erwachsenen und Kindern fortschreitet.
Hemogenyx Pharmaceuticals (HOPHF) أعلنت في 6 أكتوبر 2025 أن مجلس المراجعة المؤسسي للمراجعة في MD Anderson Cancer Center وافق على تعديل لبروتوكول المرحلة الأولى HG-CT-1 ليشمل الأطفال والمراهقين المصابين بسرطان الدم النقوي الحاد المعاود أو المقاوم (R/R AML).
وذكر البيان الصحفي أن هذا التوسع يعتمد على إشارات السلامة والفعالية المبكرة التي لوحظت لدى المشاركين البالغين ويسمح للشركة ببدء الالتحاق لدى الأطفال في تجربة HG-CT-1؛ وتقول الشركة إنها ستوفر مزيداً من التحديثات مع تقدم تسجيل البالغين والأطفال.
Hemogenyx Pharmaceuticals (HOPHF) 于 2025年10月6日 宣布，MD Anderson Cancer Center 的机构审查委员会批准对其阶段I HG-CT-1 临床方案的修订，以包含儿童和青少年，病情为复发或难治性急性髓系白血病（R/R AML）。
新闻稿称，这一扩展基于在成年参与者中观察到的安全性与早期有效性信号，并允许公司在 HG-CT-1 试验中开始< b>儿科招募；公司表示，随着成人和儿科招募的推进，将提供进一步更新。
- MD Anderson IRB approval to expand HG-CT-1 eligibility to pediatric patients
- Pediatric enrolment enabled for Phase I HG-CT-1 trial as of Oct 6, 2025
- Company cites safety and early efficacy signals in adult participants supporting expansion
- IRB clearance permits pediatric enrolment but is not regulatory marketing approval
- HG-CT-1 remains in Phase I, so clinical efficacy and commercial outcome remain unproven
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MD Anderson Clearance to Initiate Pediatric Enrolment in HG-CT-1 Clinical Trial
LONDON, GB / ACCESS Newswire / October 6, 2025 / Hemogenyx Pharmaceuticals plc (LSE:HEMO) is pleased to announce that the Institutional Review Board ("IRB") at MD Anderson Cancer Center ("MD Anderson") has approved an amendment to the clinical protocol of the Company's ongoing Phase I trial of HG-CT-1, its proprietary CAR-T cell therapy for the treatment of relapsed or refractory acute myeloid leukemia ("R/R AML").
The approved amendment expands the eligibility criteria for the trial to include children and adolescents with R/R AML, allowing the Company to begin enrolling pediatric patients into the study. This important step builds on the safety and early efficacy signals already observed in adult participants and significantly broadens the potential patient population who may benefit from HG-CT-1.
Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
"Securing IRB clearance to proceed with pediatric enrolment in our HG-CT-1 clinical trial is a major milestone. It marks the transition of HG-CT-1 into the pediatric setting, where treatment options remain limited, and demonstrates the continued momentum of our development program. This expansion not only increases the potential reach and impact of HG-CT-1 but also underscores the value of the Company's strong intellectual property portfolio, which underpins our pipeline and supports long-term growth."
The Company will provide further updates as both adult and pediatric patient enrolment progresses.
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
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FAQ
What did Hemogenyx (HOPHF) announce on October 6, 2025 about HG-CT-1?
Does the MD Anderson IRB approval mean HG-CT-1 has regulatory approval for pediatric use?
When can Hemogenyx (HOPHF) start enrolling pediatric patients into the HG-CT-1 trial?
How does the protocol amendment affect Hemogenyx's clinical development timeline?
What evidence did Hemogenyx cite to support pediatric expansion of HG-CT-1?
