Hemogenyx expands AML trial to include pediatric patients

LONDON - Hemogenyx Pharmaceuticals plc (LSE:HEMO) has made a significant move to include pediatric patients in its Phase I clinical trial for the CAR-T therapy, HG-CT-1, which is being investigated as a treatment for adults with relapsed/refractory acute myeloid leukemia (R/R AML). The company announced today that it has filed an amendment with the U.S. Food and Drug Administration (FDA) to extend the trial to children and adolescents suffering from this aggressive cancer.

The decision to amend the clinical protocol and enroll younger patients reflects Hemogenyx’s aim to address the limited treatment options currently available for pediatric R/R AML, a demographic with a particularly poor prognosis. This expansion is based on the progress made in the adult cohort of the trial, where the first two patients have already been treated with HG-CT-1.

Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, expressed the company’s dedication to fulfilling urgent medical needs by making the therapy available to younger patients. "The inclusion of children and adolescents in the trial not only reflects our commitment to addressing urgent medical needs across age groups but also supports the broader potential of HG-CT-1 as a transformative therapy for AML," said Dr. Sandler.

The amendment to the clinical protocol signifies a potential step forward in the treatment of AML across different age groups. As the trial progresses, the inclusion of pediatric patients may provide valuable data on the efficacy and safety of HG-CT-1 in a wider patient population.

The information reported is based on a press release statement from Hemogenyx Pharmaceuticals.

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