Biopharmaceutical group Hemogenyx Pharmaceuticals plc (LSE: HEMO) announced on Wednesday that it has received clearance from its independent Data Safety Monitoring Board (DSMB) to advance to the next dose level in its Phase I clinical trial of HG-CT-1, a Chimeric Antigen Receptor T-cell (CAR-T) therapy for relapsed or refractory acute myeloid leukemia (R/R AML) in adults.

The DSMB's recommendation follows a review of safety data from the first three adult patients treated at the lowest dose, with no dose-limiting toxicities observed. Progression to the next dose level also allows initiation of paediatric recruitment at the same starting dose.

The Phase I study is evaluating the safety, tolerability and early efficacy of HG-CT-1 in both adult and paediatric patients with R/R AML. Secondary endpoints include AML-specific responses, progression-free survival, duration of response and overall survival.

Hemogenyx has also awarded 6,000 Restricted Share Units to key team members under its equity incentive plan, recognising their contribution to the HG-CT-1 programme.

Headquartered in London with operations in New York, Hemogenyx Pharmaceuticals develops novel therapies for blood and autoimmune diseases.