Yes yes yes9 Feb 2024 07:04
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 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."