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Adherex’ eniluracil enters proof-of-mechanism trial

Adherex has initiated a clinical proof-of-mechanism trial of eniluracil to gather human data on the effects of low doses of eniluracil in tumor tissue.

Adherex is developing eniluracil to improve the therapeutic value and effectiveness of 5-fluorouracil (5-FU), one of the world’s most commonly used anticancer drugs.

The clinical study will primarily involve patients with colorectal cancer scheduled to undergo surgery to remove their tumors. These patients will receive a single oral dose of eniluracil prior to their surgery. Samples of tumor, surrounding normal tissue and liver will be evaluated directly for the degree and duration of eniluracil’s effect on the various enzymatic pathways for 5-FU.

This trial, which the company expects to complete in mid-2006, is designed to confirm the dose effect of eniluracil directly in tumor cells. Adherex has already demonstrated eniluracil’s effect on 5-FU metabolism in animal and human cell line studies.

“I believe 5-FU remains a very important tool in the fight against cancer. If we can make 5-FU more effective with fewer side effects, countless patients worldwide could benefit,” said Dr Robert Diasio, chairman of the department of pharmacology and toxicology at the UAB School of Medicine and an investigator for the Adherex study.

This trial is the second in a series of three preliminary studies planned for 2006 to optimize Adherex’s proprietary method of administration for the combination of eniluracil and 5-FU with the goal of returning eniluracil to phase III as early as 2007.