22 November 2024
Hemogenyx Pharmaceuticals
plc
("Hemogenyx Pharmaceuticals" or the "Company")
IRB Approval for Phase I
Clinical Trial
Hemogenyx Pharmaceuticals
Receives IRB Approval for Phase 1 Clinical Trial of HEMO-CAR-T
(HG-CT-1)
Hemogenyx Pharmaceuticals plc (LSE:
HEMO), a biopharmaceutical company developing innovative therapies
and treatments for blood diseases, is pleased to announce that the
Institutional Review Board
(IRB) of the Company's first
clinical site has granted approval to initiate a Phase I clinical trial of the Company's
lead asset, HEMO-CAR-T,
which has now been given the formal designation HG-CT-1, for the treatment of
relapsed/refractory (R/R) acute
myeloid leukemia (AML) in adults.
The proposed Phase 1 clinical trial is designed as a
dose escalation study to
assess the safety of
HG-CT-1 in adult patients with R/R AML. Secondary clinical
objectives are crucial for evaluating the broader impact of HG-CT-1
and include:
· Estimating the
efficacy of HG-CT-1 based on
standard clinical response criteria for AML.
· Estimating overall survival
(OS) in evaluable
subjects.
· Estimating progression-free
survival (PFS) in evaluable
subjects.
· Estimating duration of
response (DoR) in evaluable subjects
who achieve a clinical response.
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. This
IRB approval represents a significant 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:
"We are excited to receive IRB
approval to proceed with our Phase I clinical trial of
HEMO-CAR-T. This trial is a critical step in the development of our
CAR-T therapy for AML patients who have exhausted other treatment
options. With this study, we aim to establish the safety profile of
HG-CT-1 and gather preliminary efficacy data that could pave the
way for future therapeutic development."
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:
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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.