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Adherex Technologies Inc. (AMEX:ADH) (TSX:AHX), Research Triangle Park, N.C. a biopharmaceutical company with a broad portfolio of oncology products under development, has announced that the FDA has cleared its Investigational New Drug (IND) application for eniluracil, which the company in-licensed from GlaxoSmithKline (GSK) in July 2005. This IND clearance enables Adherex to commence U.S.-based clinical trials of eniluracil, as part of its global development plans.

"This regulatory clearance by the FDA was an important step in our efforts to rapidly develop eniluracil. In less than four months, we now have clinical quality drug and have submitted and received regulatory clearance to proceed with our initial clinical trials. We expect these trials to initiate very soon," said William P. Peters, MD, PhD, MBA, chairman and CEO. "GSK extensively studied eniluracil, in some 1,500 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, as we presented in our recent conference call, we now understand the reasons that GSK's Phase III trials failed and how to correct those problems."

Adherex's development program for eniluracil 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. Two of these studies will be conducted in the U.S.:

- 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 expected to begin shortly, with data 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.

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. Although 5-FU is a mainstay of contemporary cancer therapy, it has some therapeutic drawbacks, including that it must be given intravenously, it can cause severe and dose-limiting side effects, and it 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.

About Adherex Technologies

Adherex Technologies Inc. is a biopharmaceutical company dedicated to the discovery and development of novel cancer therapeutics. The compny aims to be a leader in developing innovative treatments that address important unmet medical needs in cancer. The company currently has multiple products in the clinical stage of development, including ADH-1 (Exherin(TM)), eniluracil and sodium thiosulfate (STS). ADH-1, our lead biotechnology compound, selectively targets N-cadherin, a protein present on certain tumor cells and established blood vessels that feed solid tumors. Eniluracil, an oral dihydropyrimidine dehydrogenase (DPD) inhibitor, was previously under development by GlaxoSmithKline for oncology indications. STS, a drug from our specialty pharmaceuticals pipeline, protects against the disabling hearing loss that can often result from treatment with platinum-based chemotherapy drugs. With a diversified portfolio of unique preclinical and clinical-stage cancer compounds and a management team with expertise in identifying, developing and commercializing novel cancer therapeutics, Adherex is emerging as a pioneering oncology company.

For more information, visit or call 919/484-8484.
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Publication:Biotech Business
Geographic Code:1CANA
Date:Jan 1, 2006

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