TNX-650 targets interleukin 13 (IL-13), an important growth factor for malignant Hodgkin's lymphoma cells. In preclinical testing, TNX-650 inhibited the function of IL-13 and blocked the proliferation of malignant cells.
The non-randomized, multiple-dose, dose-escalation trial is currently being conducted at MD Anderson Cancer Center in Houston, Texas, with additional patient enrollment expected later this year at Memorial Sloan-Kettering Cancer Center in New York City. Enrollment in the trial is expected to continue throughout 2006.
The objective of the phase I trial is to determine the safety, tolerability and pharmacokinetics of TNX-650 as a monotherapy in patients who have relapsed or are refractory to standard chemotherapy with or without radiation therapy, and who have not responded to or are unable to undergo autologous bone marrow transplantation.
Tanox expects to file an investigational new drug (IND) application with the FDA for TNX-650 in an inflammatory-disease indication later this year.
There are no approved drugs for the treatment of patients with relapsed or refractory Hodgkin's lymphoma.