Hemogenyx Pharmaceuticals PLC Announces FDA Consents to Phase I Trials of HEMO-CAR-T

Rhea-AI Summary

Hemogenyx Pharmaceuticals plc (LSE:HEMO) has received approval from the U.S. FDA to proceed with Phase I clinical trials for HEMO-CAR-T, a potential treatment for acute myeloid leukemia (AML). The FDA lifted the clinical hold on the Investigational New Drug (IND) application after the Company addressed all issues satisfactorily. CEO Dr. Vladislav Sandler expressed excitement for the opportunity to accelerate clinical development and provide a potentially life-saving treatment for patients.

FDA Consents to Phase I Trials of HEMO-CAR-T

LONDON, UK / ACCESSWIRE / February 9, 2024 / 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:

Hemogenyx Pharmaceuticals plc	https://hemogenyx.com
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder	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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SOURCE: Hemogenyx Pharmaceuticals PLC

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FAQ

What is the ticker symbol for Hemogenyx Pharmaceuticals plc?

The ticker symbol for Hemogenyx Pharmaceuticals plc is HEMO.

What type of clinical trials has the FDA approved for HEMO-CAR-T?

The FDA has consented to Phase I clinical trials for HEMO-CAR-T.

What is HEMO-CAR-T intended to treat?

HEMO-CAR-T is intended for the treatment of acute myeloid leukemia (AML).

Who is the CEO of Hemogenyx Pharmaceuticals plc?

Dr. Vladislav Sandler is the CEO of Hemogenyx Pharmaceuticals plc.

What was the reason for the FDA's previous clinical hold on HEMO-CAR-T?

The FDA had placed a clinical hold on HEMO-CAR-T due to identified issues in the Investigational New Drug (IND) application.

What is the significance of the FDA's decision to lift the clinical hold on HEMO-CAR-T?

The FDA's decision allows Hemogenyx Pharmaceuticals to proceed with the Phase I clinical study of HEMO-CAR-T, advancing its clinical development.

What is the potential impact of the FDA's decision on patients?

The decision opens up the possibility of offering patients a potentially life-saving treatment for acute myeloid leukemia (AML).