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Thymitaq Phase III Trial in Liver Cancer Continues

Berwyn, PA, May 21, 2003 – EXIMIAS Pharmaceutical Corporation announced that the second meeting of the independent Data Safety Monitoring Board (DSMB) resulted in a unanimous recommendation to continue the Phase III ETHECC© trial (Evaluation of THYMITAQ® in Hepatocellular Carcinoma). THYMITAQ® exerts its anticancer activity through direct inhibition of thymidylate synthase and is the only cytotoxic with clinical data showing a survival advantage in liver cancer.

The DSMB, responsible for evaluating patient safety and ensuring the integrity of the ETHECC© trial, met in December 2002 and at that time supported the continuation of the trial based upon an evaluation of 141 patients. The DSMB met for the second time in May 2003 to review the safety data of 233 patients randomized by the end of 2002. Mark Buyse, chairman of the DSMB, congratulated EXIMIAS on the quality of the data presented and for the way the trial is being conducted. Dr. José García–Vargas, EXIMIAS’ Vice President of Clinical Development said, “We are very pleased that the DSMB has once again approved the continuation of the ETHECC© trial without reservations.”

The Phase III ETHECC© trial is underway at nearly 70 sites in the US, Canada, Europe and South Africa. THYMITAQ® is the only drug currently in a pivotal Phase III program for the treatment of liver cancer. The trial, designed to show increased survival in patients with primary liver cancer, is planned to complete enrollment by the end of 2003. THYMITAQ® is expected to be the first novel anti-folate to market in the US.

“Now that the trial is in the completion phase of accrual, we are excited about the continued support of the DSMB to progress our ETHECC© trial. We are also very pleased that we continue to be on track for our planned NDA submission in 2004,” said Dr. Elizabeth Corsi, President and CEO.

Source: EXIMIAS Pharmaceutical Corporation

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