REG - Hemogenyx Pharma Plc - Clearance to Initiate Pediatric Enrolment

Hemogenyx PharmaceuticalsAnnouncement

06/10/2025 07:00

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RNS Number : 1679C  Hemogenyx Pharmaceuticals PLC  06 October 2025

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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:

 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.

 

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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