RCS - Hemogenyx Pharma Plc - Pediatric Amendment to Clinical Protocol

Hemogenyx PharmaceuticalsAnnouncement

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RNS Number : 5168I  Hemogenyx Pharmaceuticals PLC  14 May 2025

 

14 May 2025

 

Hemogenyx Pharmaceuticals plc

 

("Hemogenyx Pharmaceuticals" or the "Company")

 

Amendment to Clinical Protocol for HG-CT-1 to Include Pediatric Patients with
R/R AML

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                                   https://hemogenyx.com (https://hemogenyx.com/)
 Dr Vladislav Sandler, Chief Executive Officer & Co-Founder      headquarters@hemogenyx.com (mailto:headquarters@hemogenyx.com)
 Peter Redmond, Director                                         peter.redmond@hemogenyx.com (mailto:peter.redmond@hemogenyx.com)
 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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