9 February 2024
Hemogenyx Pharmaceuticals
plc
("Hemogenyx Pharmaceuticals" or the "Company")
FDA Consents to Phase I
Trials of HEMO-CAR-T
Hemogenyx Pharmaceuticals plc (LSE:
HEMO) is pleased to announce that it has been informed by the U.S.
Federal Food and Drug Administration ("FDA") that it has lifted the
clinical hold on the Investigational New
Drug (IND) application for HEMO-CAR-T for the treatment of acute
myeloid leukemia ("AML"). The FDA confirmed that the Company
had addressed all issues
identified in its prior
clinical hold letter satisfactorily and consents to the Company proceeding with its
Phase I clinical study of HEMO-CAR-T.
Dr
Vladislav Sandler, CEO & Co-Founder of Hemogenyx
Pharmaceuticals, commented: "We
are extremely pleased with the FDA's decision to lift the clinical
hold. We now look forward to accelerating clinical development of
HEMO-CAR-T and to offering patients a potentially life-saving
treatment. The removal of the clinical hold was made possible by
the hard work and dedication of the entire Hemogenyx
Pharmaceuticals team and its Board of Directors and
advisors."
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
form 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 pre-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.