Medarex, a biopharmaceutical company, has reported encouraging preliminary data from an ongoing Phase I clinical trial of MDX-1401 in patients with relapsed or refractory Hodgkin’s lymphoma that demonstrated both clinical and immunological activity signals.
An ongoing multi-dose, dose-escalation Phase I trial of MDX-1401 in patients with relapsed or refractory Hodgkin’s lymphoma (HL) is being conducted to establish and evaluate the safety profile and initial efficacy of MDX-1401.
Preliminary data from the Phase I trial demonstrate that multiple doses (ranging from 0.01 to 1mg/kg) of MDX-1401 in patients with HL were generally safe and well-tolerated. Approximately two of the eight patients with stable disease had a reduction of 40% or more in tumor burden after two treatment cycles of MDX-1401. In addition, flow cytometry indicated decreased circulating CD30 positive cells in 83% of patients (10/12) after one cycle of four weekly intravenous infusions.
According to Medarex, MDX-1401 is a fully human, non-fucosylated antibody that targets CD30, a marker for activated lymphocytes that is present on malignant cells of HL as well as other CD30-expressing cancers.
Geoffrey Nichol, senior vice president of product development at Medarex, said: We find these preliminary safety and efficacy data for our second generation anti-CD30 antibody encouraging. We are currently enrolling additional patients at higher dose levels and look forward to examining further results from the ongoing Phase I trial.