Adherex receives clearance for anticancer drug trials

Eniluracil is a drug designed to improve the effectiveness of 5-FU, one of the world’s most commonly used chemotherapies, by inhibiting its breakdown. Adherex in-licensed the drug from GlaxoSmithKline in July 2005.

The development program includes preliminary studies designed to further define the optimal dose of eniluracil, the optimal dose ratio and schedule of eniluracil in combination with 5-FU, and the anti-tumor activity of the proper combination of the two drugs.

The first study will enroll approximately 20 patients with colorectal cancer who will undergo surgery to remove their tumors. These patients will receive an oral dose of eniluracil prior to their surgery. Samples of tumor and normal tissues will be evaluated for the duration of eniluracil’s effect on the enzymes involved in the activation and breakdown of 5-FU. This trial is scheduled to begin shortly, with data expected to be made available in the first half of 2006.

The second study will enroll approximately 20 patients. This phase I trial is expected to initiate in early 2006 and be completed in six to eight months. Adherex expects that this trial will evolve into a phase II trial in breast cancer patients, which should conclude in the first half of 2007.

In addition, Adherex plans to begin a phase I/II trial in Asia in the second quarter of 2006 in patients with liver cancer. It is expected that a phase III trial in liver cancer could begin by mid-2007.

“GSK extensively studied eniluracil, in some 1500 patients, so we already know a good deal about this drug. For instance, we know that the dose ranges we plan to use in our clinical studies were well tolerated. And we now understand the reasons that GSK’s phase III trials failed and how to correct those problems,” said Dr William Peters, chairman and CEO of Adherex.