EPICEPT BEGINS TRIAL OF TREATMENT FOR TUMORS, LYMPHOMAS

EpiCept has initiated a Phase I clinical study of EPC2407, a novel small-molecule vascular disruption agent and apoptosis inducer for the treatment of patients with advanced solid tumors and lymphomas. EPC2407 is the first of a novel class of microtubulin inhibitors discovered by EpiCept. These compounds cause caspase activation, cell cycle arrest and apoptotic death in cancer cells.

Preclinical studies show that the antitumor effects of EPC2407 result from dual mechanisms, a primary effect on disruption of tumor vascular endothelial cells leading to hypoxia and central tumor necrosis, as observed with other vascular disruption agents; and a second and more direct apoptotic effect as well.

The Phase I trial of EPC2407 is being conducted in two U.S. cancer centers and will administer increasing doses to small groups in approximately 30 patients with advanced stages of solid tumors. The primary objectives of the study are to determine the safe doses and blood concentrations of the drug (maximum tolerated dose and pharmacokinetics). The study will also characterize the pharmacodynamic effects on blood flow and identify early signs of antitumor response. The trial is expected to last one year.

EPC2407 is intended for the treatment of advanced cancer patients with solid tumors that are well vascularized. These tumors include the frequently occurring cancers of the lung, gastrointestinal tract, ovaries and breast. Despite encouraging progress in treating earlier stages of these diseases, these cancers continue to have high mortality rates in spite of some new classes of antitumor agents in recent years.