REG - Hemogenyx Pharma Plc - Schedule for Phase I Clinical Trial Opening

Hemogenyx PharmaceuticalsAnnouncement

30/10/2024 07:00

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RNS Number : 1066K  Hemogenyx Pharmaceuticals PLC  30 October 2024

30 October 2024

 

Hemogenyx Pharmaceuticals plc

("Hemogenyx Pharmaceuticals" or the "Company")

Schedule for Phase I Clinical Trial Opening

 

Hemogenyx Pharmaceuticals Announces Schedule for Opening First Clinical Site
for Phase I Trial of HEMO-CAR-T (HG-CT-1)

 

Hemogenyx Pharmaceuticals plc (LSE: HEMO), a biopharmaceutical company focused
on developing breakthrough therapies for blood diseases, is pleased to
announce the schedule for the opening of the first clinical site for its lead
asset, HEMO-CAR-T, formally designated HG-CT-1, targeting relapsed/refractory
(R/R) acute myeloid leukemia (AML) in adults.

The Company has successfully completed the necessary contracts and budgeting
preparations to advance HG-CT-1 into clinical testing. Institutional Review
Board (IRB) approval at the initial clinical site is anticipated by the second
week of November. Following IRB clearance, a Site Initiation Visit (SIV) is
expected to take place in the third week of November, marking the official
launch of the Phase I clinical trial.

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 will represent 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:
"Launching this Phase I clinical trial for HG-CT-1 will mark a critical step
forward in our mission to develop transformative therapies for patients
battling relapsed and refractory acute myeloid leukemia. For patients who have
few remaining treatment options, HG-CT-1 offers a potentially life-saving
solution. We are eager to initiate this trial and generate data that will be
essential in advancing this therapy toward broader clinical use. This
milestone underscores our commitment to innovation and our dedication to
addressing the urgent needs of patients with severe blood cancers."

 

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.

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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