Hemogenyx Pharmaceuticals PLC Announces Submission of Complete Response to Clinical Hold

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Hemogenyx Pharmaceuticals plc (LSE:HEMO) has submitted a complete response to the previously announced Clinical Hold of the Investigational New Drug application to the US Food and Drug Administration for HEMO-CAR-T. The submission is necessary to apply for the lifting of the Clinical Hold, which is needed to obtain consent from the FDA to commence Phase I clinical trials of HEMO-CAR-T. Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, expressed optimism about the filing, stating that they are pleased to have addressed the FDA's concerns and look forward to becoming a clinical stage biopharmaceutical company once consent is received from the FDA.

Submission of Complete Response to Clinical Hold for HEMO-CAR-T IND

LONDON, UK / ACCESSWIRE / January 16, 2024 / Hemogenyx Pharmaceuticals plc (LSE:HEMO) announces the submission of a complete response tothe previously announced Clinical Hold ("CH") of the Investigational New Drug ("IND") application to the US Food and Drug Administration ("FDA") for HEMO-CAR-T. A complete response isnecessary to apply for the lifting of the CH which is needed to obtain consent from the FDA to commence Phase I clinical trials of HEMO-CAR-T.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "We are pleased to have filed a complete response to the FDA addressing their concerns that resulted in a CH of the HEMO-CAR-T IND. We look forward to becoming a clinical stage biopharmaceutical company once consent is received from the FDA."

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.

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

View the original press release on accesswire.com

FAQ

What is the ticker symbol for Hemogenyx Pharmaceuticals plc?

The ticker symbol for Hemogenyx Pharmaceuticals plc is HEMO.

What is the purpose of the submission mentioned in the press release?

The submission is to apply for the lifting of the Clinical Hold of the Investigational New Drug application to the US Food and Drug Administration for HEMO-CAR-T.

Who commented on the submission in the press release?

Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented on the submission in the press release.

What is the significance of obtaining consent from the FDA?

Obtaining consent from the FDA is necessary to commence Phase I clinical trials of HEMO-CAR-T.

What did Dr. Vladislav Sandler express in the press release?

Dr. Vladislav Sandler expressed optimism about the filing, stating that they are pleased to have addressed the FDA's concerns and look forward to becoming a clinical stage biopharmaceutical company once consent is received from the FDA.