Hemogenyx Pharmaceuticals plc (LSE: HEMO) announced on Wednesday that it has submitted an amendment to the U.S. Food and Drug Administration to expand its Phase I clinical trial of HG-CT-1 to include paediatric patients with relapsed/refractory acute myeloid leukemia (R/R AML). The CAR-T therapy is currently in clinical testing for adult patients.
The inclusion of children and adolescents aims to address the urgent need for effective treatments in this high-risk population, where therapeutic options remain limited and outcomes poor. The decision underscores Hemogenyx Pharmaceuticals' strategy to broaden the therapeutic reach of HG-CT-1.
Progress continues in the adult cohort, with two patients already dosed.
Headquartered in London with operations in New York, the company remains focused on advancing innovative therapies for blood and autoimmune disorders.
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