REG - Hemogenyx Pharma Plc - FDA Consents to Phase I Trials of HEMO-CAR-T

Hemogenyx PharmaceuticalsAnnouncement

09/02/2024 07:00

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RNS Number : 5636C  Hemogenyx Pharmaceuticals PLC  09 February 2024

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
(https://www.londonstockexchange.com/news-article/HEMO/clinical-hold-on-ind-for-hemo-car-t/15983515)
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:

 

 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

 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 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.

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