Hemogenyx Pharmaceuticals (LON: HEMO) has received clearance from its independent Data Safety Monitoring Board (DSMB) to proceed to the next adult dose level in its Phase I clinical trial of HG-CT-1, the company’s proprietary CAR-T therapy targeting relapsed or refractory acute myeloid leukaemia (AML).
The decision follows a successful safety review of the first three adult patients, with no dose-limiting toxicities observed. The DSMB’s approval also allows pediatric patient recruitment to begin at the initial dose level.
The ongoing dose-escalation study is designed to evaluate safety, tolerability, and preliminary efficacy of HG-CT-1 across both adult and pediatric cohorts — marking a key de-risking milestone and potential value inflexion point as higher-dose testing commences.
To acknowledge the contribution of its scientific team, Hemogenyx granted 6,000 Restricted Share Units (RSUs) to key staff members.
CEO Dr. Vladislav Sandler said the DSMB’s clearance “validates HG-CT-1’s safety profile and demonstrates continued progress toward delivering this potentially life-saving therapy to patients in need.”
