Hemogenyx Pharmaceuticals PLC (LSE:HEMO, OTC:HOPHF) shares climbed as much as 8% in early trading after the biotech company said US regulators had cleared its experimental CAR-T therapy for leukaemia to move to a higher dose level in its ongoing Phase I trial.
The independent Data Safety Monitoring Board, which oversees the study, reviewed safety data from the first three adult patients treated with Hemogenyx’s HG-CT-1 therapy for relapsed or refractory acute myeloid leukaemia and found no dose-limiting toxicities. As a result, the trial can now advance to the next dose cohort.
The decision also allows the company to begin recruiting paediatric patients at the lowest adult dose. The expansion marks a key milestone for Hemogenyx as it looks to extend the potential benefits of its CAR-T treatment to children with this aggressive blood cancer.
The Phase I study is designed to assess safety, tolerability and early signs of efficacy in both adult and paediatric participants. Secondary goals include measuring disease response, progression-free survival and overall survival rates.
Chief executive Dr Vladislav Sandler said the decision represented “continued progress in our clinical development programme” and reinforced the therapy’s “favourable safety profile”.
He added that the company remained “encouraged by the early clinical findings” as it moved towards higher doses that could show stronger therapeutic effects.
After an early surge, the stock settled at 1,015p, up 35p.