Policy & Regulation
Hemogenyx Pharmaceuticals plc granted FDA consent for Phase I trials of HEMO-CAR-T in AML treatment
9 February 2024 -

Hemogenyx Pharmaceuticals plc (LON:HEMO), a pre-clinical stage biopharmaceutical company, announced on Friday that it has received clearance from the US Federal Food and Drug Administration (FDA) for Phase I trials of HEMO-CAR-T for the treatment of acute myeloid leukaemia (AML).

The FDA lifted the clinical hold on the Investigational New Drug (IND) application after the company addressed all identified issues satisfactorily.

Welcoming the decision, Dr Vladislav Sandler, CEO and co-founder of Hemogenyx Pharmaceuticals, said: "We now look forward to accelerating clinical development of HEMO-CAR-T and to offering patients a potentially life-saving treatment."

AML, the most common type of acute leukaemia in adults, is currently treated with chemotherapy and has poor survival rates. CAR-T therapy modifies a patient's T-cells to recognise and eliminate cancer cells, offering a potentially more benign and effective treatment for AML. The process involves isolating, modifying, amplifying and reintroducing the patient's T-cells.