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.
Indivior updates on Aelis Farma's Phase 2B study of AEF0117 for Cannabis Use Disorder
Vesper Bio announces positive Phase I results for FTD treatment
Empower Pharmacy names new president
Innovent's IBI363 receives US FDA Fast Track Designation
Valneva and Pfizer report positive Phase 2 booster results for Lyme disease vaccine
Grit Biotechnology's GT201 receives US FDA IND approval
Cereno Scientific doses first patient in Expanded Access Program for PAH
Medicilon USA begins operations at second R&D centre in Massachusetts
CS Genetics names new chief operating officer and chief scientific officer
Expanse Medical names new chief executive officer and FlowPhysix board member