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On 6 October 2025, the Institutional Review Board (IRB) at MD Anderson Cancer Center approved an amendment to the clinical protocol for Hemogenyx Pharmaceuticals plc's ongoing Phase I trial of HG-CT-1. This amendment expands the trial's eligibility criteria to include children and adolescents with relapsed or refractory acute myeloid leukemia (R/R AML), allowing the Company to begin enrolling pediatric patients into the study.
| Date | 6 Oct 2025 |
| Time | 07:00:08 |
| Category | Miscellaneous |
| ID | 1679C |
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6 October 2025
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
MD Anderson Clearance to Initiate Pediatric Enrolment in HG-CT-1 Clinical Trial
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:
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Hemogenyx Pharmaceuticals plc |
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Dr Vladislav Sandler, Chief Executive Officer & Co-Founder |
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Peter Redmond, Director |
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SP Angel Corporate Finance LLP |
Tel: +44 (0)20 3470 0470 |
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Matthew Johnson, Vadim Alexandre, Adam Cowl |
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Peterhouse Capital Limited |
Tel: +44 (0)20 7469 0930 |
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Lucy Williams, Duncan Vasey, Charles Goodfellow |
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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.