Hemogenyx Pharmaceuticals PLC (LSE:HEMO, OTC:HOPHF) shares drove higher in Friday morning’s dealing, rising over 10% at one point, after it received Institutional Review Board (IRB) approval to begin a Phase I clinical trial for its lead therapy, HEMO-CAR-T, formally designated HG-CT-1.
The trial will target adult patients suffering from relapsed/refractory acute myeloid leukemia (R/R AML).
The Phase I trial is structured as a dose-escalation study to evaluate the safety of HG-CT-1.
Secondary objectives will assess the therapy’s efficacy using standard response criteria for AML, as well as estimate overall survival (OS), progression-free survival (PFS), and duration of response (DoR).
"We are excited to receive IRB approval to proceed with our Phase I clinical trial of HEMO-CAR-T,” chief executive Dr Vladislav Sandler said in a statement.
“This trial is a critical step in the development of our CAR-T therapy for AML patients who have exhausted other treatment options.
“With this study, we aim to establish the safety profile of HG-CT-1 and gather preliminary efficacy data that could pave the way for future therapeutic development."
In London, Hemogenyx shares were up around 5% changing hands at 1.6p, having traded up to 1.8p earlier.