Hemogenyx Pharmaceuticals Regulatory News (HEMO)

9 December 2024

Hemogenyx Pharmaceuticals plc 

("Hemogenyx Pharmaceuticals" or the "Company")

Site Initiation Visit Completed

Hemogenyx Pharmaceuticals Successfully Completes the Site Initiation Visit of the First Clinical Site for Phase I Clinical Trial of HG-CT-1

Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical company developing innovative therapies for blood diseases, is pleased to announce the successful completion of the Site Initiation Visit at the first clinical site for its Phase I clinical trial of HG-CT-1 (also known as HEMO-CAR-T). The Phase I clinical trial is designed as a dose escalation study to assess the safety of HG-CT-1 in adult patients with relapsed/refractory (R/R) acute myeloid leukaemia (AML).

Patient recruitment will begin once the clinical site provides final details to the Company's clinical trials manager, Prevail Infoworks.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "This step marks a significant milestone for the Company as we advance our lead asset, HG-CT-1, into clinical trials. This study represents our commitment to developing innovative therapies for patients with R/R AML, a condition with limited treatment options.

We are excited to see patient recruitment set to begin and take the next steps in assessing the safety and treatment potential of HEMO-CAR-T. We remain dedicated to delivering transformative therapies that address critical unmet medical needs."

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.

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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.