Hemogenyx Pharmaceuticals PLC Announces Pediatric Amendment to Clinical Protocol
Rhea-AI Summary
Hemogenyx Pharmaceuticals (LSE:HEMO) has filed an amendment to its ongoing Phase I clinical trial protocol for HG-CT-1, its CAR-T therapy for relapsed/refractory acute myeloid leukemia (R/R AML). The amendment seeks to expand trial eligibility to include children and adolescents, beyond the current adult patient population. This expansion aims to address a critical unmet medical need in pediatric oncology, particularly for R/R AML, which has limited treatment options and poor prognosis. The company has already treated two patients in the adult cohort of the trial.
Positive
- Expansion of potential patient population for HG-CT-1 therapy to include pediatric patients
- Progress in clinical trials with first two adult patients already treated
- Addressing an unmet medical need in pediatric oncology with limited treatment options
Negative
- Still in early Phase I trials with limited patient data
- Success in adult patients may not translate to pediatric population
Amendment to Clinical Protocol for HG-CT-1 to Include Pediatric Patients with R/R AML
LONDON, UNITED KINGDOM / ACCESS Newswire / May 14, 2025 / Hemogenyx Pharmaceuticals plc (LSE:HEMO) is pleased to announce that it has filed an amendment to the clinical protocol for its ongoing Phase I clinical trial of HG-CT-1 to include pediatric patients with relapsed/refractory acute myeloid leukemia ("R/R AML"). HG-CT-1 is the Company's CAR-T therapy, currently undergoing clinical trials in adults for the treatment of R/R AML.
This amendment, filed with the U.S. Food and Drug Administration (FDA), seeks to expand eligibility for the trial beyond adult patients to include children and adolescents with R/R AML, an aggressive disease with limited treatment options and poor prognosis in the relapsed/refractory setting. The expansion reflects the Company's commitment to broadening the potential impact of HG-CT-1 and addressing a critical unmet medical need in pediatric oncology.
The amendment builds on the Company's progress to date in the adult cohort of the trial, in which the first two patients have already been treated.
Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
"We are pleased to take this important step toward making HG-CT-1 available to pediatric patients who currently have very few therapeutic options. The inclusion of children and adolescents in the trial not only reflects our commitment to addressing urgent medical needs across age groups but also supports the broader potential of HG-CT-1 as a transformative therapy for AML."
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
View the original press release on ACCESS Newswire
FAQ
What is the latest update on Hemogenyx Pharmaceuticals' (HOPHF) HG-CT-1 clinical trial?
How many patients have been treated with HG-CT-1 in Hemogenyx's clinical trial?
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