EpiCept completes Ph I EPC2407 trial

New Jersey, USA-based EpiCept has completed its Phase I clinical trial for EPC2407. The trial has met all of its objectives. The drug is a novel small-molecule vascular disruption agent (VDA) and apoptosis inducer for the treatment of patients with advanced solid tumors and lymphomas.

EpiCept successfully identified the maximum tolerated dose of EPC2407 in the Phase I study. The maximum tolerated dose was well below that which produced the expected toxicity based on preclinical studies at higher levels. The drug was administered as a single agent in increasing doses to small cohorts of patients with advanced solid tumors. A total of 17 subjects were enrolled in the study and the drug was tested in a variety of cancer types including melanoma, prostate, lung, breast, colon and pancreatic. The study, which was initiated in December 2006, was conducted at three cancer centers in the USA.

"We are pleased that this milestone has been reached," stated Jack Talley, chief executive, adding: "we are now in the process of meeting with our advisors to move forward with a Phase Ib combination trial for the drug with other chemotherapeutic agents. We anticipate being able to initiate this combination trial in early 2008."