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REG - Hemogenyx Pharma Plc - Opening of First Clinical Site

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RNS Number : 4996R  Hemogenyx Pharmaceuticals PLC  30 December 2024

30 December 2024

 

Hemogenyx Pharmaceuticals plc

("Hemogenyx Pharmaceuticals" or the "Company")

 

Hemogenyx Pharmaceuticals Opens First Clinical Site for HG-CT-1 Phase I Trial

Patient Recruitment Begins for CAR-T Cell Therapy Targeting
Relapsed/Refractory Acute Myeloid Leukemia in Adults

 

Hemogenyx Pharmaceuticals plc (LSE: HEMO) is pleased to announce the opening
of the first clinical site for its lead asset, HG-CT-1, targeting
relapsed/refractory (R/R) acute myeloid leukemia (AML) in adults. Recruitment
of patients for the trials has begun.

This Phase I trial is designed as a dose-escalation study to evaluate the
safety profile of HG-CT-1 in adult patients with R/R AML. Key secondary
objectives include assessing the therapy's impact on the following clinical
outcomes:

·      Efficacy of HG-CT-1 based on AML-specific response criteria

·      Overall survival (OS) rates among participating subjects

·      Progression-free survival (PFS) in evaluable subjects

·      Duration of response (DoR) in those who achieve clinical
responses.

These objectives are pivotal for assessing the overall clinical impact of
HG-CT-1 on patients with R/R AML, a population with few remaining therapeutic
options. The commencement of this trial represents a major milestone for
Hemogenyx Pharmaceuticals, enabling the Company to advance this promising
therapy into clinical testing at one of the world's most prestigious cancer
research institutions.

 

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals,
commented:
" The opening of our first clinical site for the Phase I trial of HG-CT-1 is a
milestone in our mission to revolutionize the treatment landscape for relapsed
and refractory acute myeloid leukemia. This trial offers hope to patients who
currently face limited treatment options by exploring the safety and potential
efficacy of HG-CT-1. We are excited to start this pivotal study."

 

About AML and CAR-T Therapy

AML, the most common type of acute leukemia in adults, has poor survival rates
(a five-year survival rate of less than 30% in adults) and is currently
treated using chemotherapy, rather than the potentially more benign and
effective forms of therapy being developed by Hemogenyx Pharmaceuticals. The
successful development of a new therapy for AML would have a major impact on
treatment and survival rates for the disease.

CAR-T therapy is a treatment in which a patient's own T-cells, a type of
immune cell, are modified to recognize and kill the patient's cancer cells.
The procedure involves: isolating T-cells from the patient; modifying the
isolated T-cells in a laboratory using a CAR gene construct (which allows the
cells to recognize the patient's cancer); amplifying (growing to large
numbers) the newly modified cells; and re-introducing the cells back into the
patient.

 

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 disease and to bring
the curative power of bone marrow transplantation to a greater number of
patients suffering from otherwise incurable life-threatening diseases.
Hemogenyx Pharmaceuticals is developing several distinct and complementary
product candidates, as well as a platform technology that it uses as an engine
for novel product development.

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