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:
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Hemogenyx Pharmaceuticals plc
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https://hemogenyx.com
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Dr Vladislav Sandler, Chief
Executive Officer & Co-Founder
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headquarters@hemogenyx.com
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Peter Redmond, Director
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peter.redmond@hemogenyx.com
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SP
Angel Corporate Finance LLP
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Tel: +44 (0)20 3470 0470
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Matthew Johnson, Vadim Alexandre,
Adam Cowl
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Peterhouse Capital Limited
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Tel: +44 (0)20 7469 0930
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Lucy Williams, Duncan Vasey, Charles
Goodfellow
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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.