Adherex starts phase 1 eniluracil trial

By Lisa Kerner

Erie, Pa., Jan. 4 - Adherex Technologies Inc. announced the activation of a phase 1 clinical trial of the combination of eniluracil and 5-fluorouracil (5-FU). This study follows Adherex's announcement in late November that the U.S. Food and Drug Administration (FDA) had cleared its Investigational New Drug (IND) application for eniluracil.

"Eniluracil represents a considerable therapeutic and commercial opportunity for Adherex. It has the potential to make a mainstay of contemporary cancer therapy, 5-FU, even better, and could have a market opportunity in excess of a billion dollars," said William P. Peters, chairman and chief executive officer of Adherex, in a news release.

"Importantly, since eniluracil has already been extensively studied by GlaxoSmithKline in more than 1,500 patients, we expect to be able to shorten the development timelines and initiate phase 3 trials by mid 2007. This phase 1 trial, which is intended to demonstrate the safety of our proprietary combination, should take only six to eight months to complete."

The phase 1 dose escalation study will enroll patients with solid tumors and is intended to define the maximum tolerated dose of weekly dosing of the combination of eniluracil and 5-FU. Adherex expects the study to be complete in the third quarter. The company then plans to begin a phase 2 trial in breast cancer.

In November, Adherex announced its plans for eniluracil, including three preliminary studies to define the optimal dose of eniluracil, the optimal dose ratio and schedule of eniluracil in combination with 5-FU, and the clinical response rate to Adherex's proprietary combination of the two drugs.

The first of these studies is the phase 1 study announced above. A second phase 2 study, expected to begin shortly, will investigate the specific effects of eniluracil on the enzymatic pathways of 5-FU metabolism in patients with colorectal cancer who undergo surgery to remove their tumors. The third study, a phase 1/2 clinical trial in liver cancer, is expected to begin in the second quarter in Asia.

In December, the company received orphan drug designation for the use of eniluracil in combination with fluoropyrimidines (including 5-FU) for the treatment of hepatocellular cancer. Adherex expects a phase 3 trial of the combination of eniluracil and 5-FU in hepatocellular cancer could begin by mid 2007.

Adherex is developing eniluracil, which it licensed from GlaxoSmithKline in July, to improve the therapeutic value and effectiveness of 5-FU, one of the most commonly used anti-cancer drugs. Adherex's preclinical data indicates that when eniluracil and 5-FU are combined in the proper dose, dose ratio and schedule, the combination can be more effective and less toxic than 5-FU or similar 5-FU drugs alone.

Although 5-FU is a mainstay of contemporary cancer therapy, it has some therapeutic drawbacks, according to the company. These include that it must be given intravenously, it can cause severe and often dose-limiting side effects, and it has variable blood and tissue levels which can impact its anti-tumor activity and safety profile. In combination with eniluracil, 5-FU is orally active and has more uniform and prolonged blood and tissue levels, thereby potentially improving its side effect profile and anti-tumor effects.

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

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