REG - Hemogenyx Pharma Plc - Clearance to Proceed with Pediatric Expansion

Hemogenyx PharmaceuticalsAnnouncement

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RNS Number : 0349N  Hemogenyx Pharmaceuticals PLC  17 June 2025

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS STIPULATED UNDER THE UK
VERSION OF THE MARKET ABUSE REGULATION NO 596/2014 WHICH IS PART OF ENGLISH
LAW BY VIRTUE OF THE EUROPEAN (WITHDRAWAL) ACT 2018, AS AMENDED.  ON
PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS
INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

 

17 June 2025

 

Hemogenyx Pharmaceuticals plc

("Hemogenyx Pharmaceuticals" or the "Company")

 

Regulatory Clearance to Proceed with Pediatric Expansion of HG-CT-1 Clinical
Trial

Hemogenyx Pharmaceuticals plc (LSE: HEMO) is pleased to announce that the
30-day review period by the U.S. Food and Drug Administration (FDA) for the
Company's previously submitted amendment
(https://www.londonstockexchange.com/news-article/HEMO/pediatric-amendment-to-clinical-protocol/17034775)
to the clinical protocol of its ongoing Phase I trial of HG-CT-1 has concluded
without a clinical hold. As a result, the Company is now cleared to proceed
with the next steps required to initiate pediatric enrolment in the trial.

The protocol amendment expands the eligibility criteria for the Phase I trial
of HG-CT-1, Hemogenyx's proprietary CAR-T therapy for relapsed/refractory
acute myeloid leukemia (R/R AML), to include children and adolescents with
this aggressive and hard-to-treat disease.

The Company will now move forward with Institutional Review Board (IRB)
submissions and associated site activation procedures to enable the opening of
pediatric cohorts.

Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals,
commented:

"Regulatory clearance to proceed with the pediatric expansion of our HG-CT-1
clinical trial is a significant milestone. It reflects continued momentum in
our development program and underscores our commitment to delivering
innovative therapies to patients across age groups. This expansion broadens
the potential impact and value of HG-CT-1 as we continue to advance toward key
inflection points in the clinic. Importantly, it also reinforces the value of
Company's robust intellectual property portfolio, which underpins our pipeline
and supports long-term strategic growth."

The Company will update the market as further progress is made in pediatric
site activation and patient enrolment.

Market Abuse Regulation (MAR) Disclosure

Certain information contained in this announcement would have been inside
information for the purposes of Article 7 of Regulation No 596/2014 (as it
forms part of UK domestic law by virtue of the European Union (Withdrawal) Act
2018) until the release of this announcement. The person responsible for
arranging for the release of this announcement on behalf of Hemogenyx
Pharmaceuticals plc is Dr Vladislav Sandler, Chief Executive Officer &
Co-Founder.

 

 

 

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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