Adherex's Investigational New Drug Application for eniluracil approved by FDA

New York, Nov. 28 - Adherex Technologies Inc. said the Food and Drug Administration approved its Investigational New Drug Application for eniluracil.

Adherex, which licensed the drug from GlaxoSmithKline in July, will now be able to start U.S.-based clinical trials of the compound. Eniluracil is designed to improve the effectiveness of 5-FU, one of the world's most commonly used chemotherapies, by inhibiting its breakdown.

"GSK extensively studied eniluracil, in some 1,500 patients, so we already know a good deal about this drug," said William Peters, Adherex's chairman and chief executive officer, in a news release.

"For instance, we know that the dose ranges we plan to use in our clinical studies were well tolerated. And, as we presented in our recent conference call, we now understand the reasons that GSK's phase 3 trials failed and how to correct those problems."

Adherex said it plans studies to further define the optimal dose of eniluracil and the optimal dose ratio and schedule of eniluracil in combination with 5-FU. It will also be looking at the anti-tumor activity of the proper combination of the two drugs.

The first planned study will enroll about 20 patients in the United States 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 expected to begin shortly, with data available in the first half of 2006.

The second study will also enroll about 20 patients, also in the United States. This phase 1 trial is expected to begin in early 2006 and be completed in six to eight months. Adherex expects that this trial will evolve into a phase 2 trial in breast cancer patients and should conclude in the first half of 2007.

Adherex also plans to begin a phase 1 and 2 trial in Asia in the second quarter of 2006 in patients with liver cancer. It is expected that a phase 3 trial in liver cancer could begin by mid-2007.

Currently 5-FU must be given intravenously, can cause severe and dose-limiting side effects, and has variable blood and tissue levels which impact its anti-tumor activity and safety profile. In combination with eniluracil, 5-FU can become orally active, have fewer side effects, and more uniform and prolonged blood levels, thereby potentially improving its safety and anti-tumor effect, Adherex said.

Adherex is a Research Triangle Park, N.C., biopharmaceutical company.

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