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EpiCept Accelerates Development of Phase I Clinical Study for Cancer

EpiCept Corporation today announced that with the initiation of a new study center, Tower Cancer Research Foundation in Los Angeles, it will accelerate the recruitment of patients in the currently ongoing Phase I clinical study of EPC2407, a novel small molecule vascular disruption agent (VDA) and apoptosis inducer for the treatment of patients with advanced solid tumors and lymphomas. The first two cohorts of patients have been completed according to schedule at Scottsdale Healthcare Center. The third cohort is currently ongoing at Scottsdale Healthcare Center and at the University of California, Moores Cancer Center, San Diego.

EPC2407 belongs to a novel class of microtubulin inhibitors discovered by EpiCept. These compounds cause caspase activation, cell cycle arrest, and apoptotic death in cancer cells.

The Phase I trial of EPC2407 is now being conducted in three U.S. cancer centers and will administer increasing doses to small groups in approximately 30-40 patients with advanced stages of solid tumors. The primary objectives of the study are to determine the safety (maximum tolerated dose) and the pharmacokinetic profile of the drug. The study will also characterize the pharmacodynamic effects on tumor blood flow and identify early signs of objective anti-tumor response as measured by CT scans, MRI or PET, in these advanced cancer patients with well vascularized solid tumors.

Dr. Peter J. Rosen, Medical Director at Tower Cancer Research Foundation, stated, "Tower Oncology is very excited to work with EpiCept on the clinical development of EPC2407, a product with a new mechanistic approach, which could offer significant advantages in the fight against cancer."

EpiCept President and Chief Executive Officer Jack Talley commented, "We are pleased to be joined by Tower Cancer Research Foundation in the development of EPC2407 and we believe that their participation will result in our completing the trial ahead of p lan. We expect to be in a position to report the results of this important clinical trial later this year."

EPC2407 has shown promising vascular targeting activity with nanomolar potencies of anti-tumor activity in pre-clinical in vitro and in vivo studies. The molecule has been shown to induce tumor cell apoptosis and selectively inhibit growth of proliferating cell lines, including multi-drug resistant cell lines. Murine models of human tumor xenografts demonstrated EPC2407 inhibits growth of established tumors of a number of different cancer types more effectively than the other VDAs tested and was synergistic when used in combination with anticancer agents, such as Cisplatin. The combination of EPC2407 with other anticancer agents in a Phase 1b trial is planned to follow the current monotherapy trial. EPC2407 is one of two VDA compounds currently in clinical trials discovered through EpiCept's Anti-cancer Screening Apoptosis Program (ASAP). The second compound, Azixa(TM), is part of the EP90745 series of apoptosis inducers, which was licensed by EpiCept to Myriad Genetics, Inc. as part of an exclusive, worldwide development and commercialization agreement. Myriad recently announced that Azixa(TM) has a second mode of action due to vascular disruption activity (VDA). The compound is currently being evaluated in two Phase II human clinical trials, one in patients with primary brain cancer and the other in brain metastases due to melanoma. EpiCept's licensing agreement with Myriad for Azixa includes milestone payments, and sublicensing income as well as future royalties in the event Myriad's development of Azixa continues to progress successfully.

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