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Adherex Receives Investigational New Drug 'IND' Clearance from FDA for Eniluracil.


RESEARCH TRIANGLE PARK Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. , N.C. -- Adherex Technologies Inc. (AMEX AMEX

See: American Stock Exchange
:ADH ADH: see antidiuretic hormone. ) (TSX TSX Toronto Stock Exchange (TSE before April, 2002)
TSX Transfer from Stack Pointer to Index
TSX True Space Extension
:AHX AHX American History X (movie)
AHX Abyss' Highest eXperience
), a biopharmaceutical company with a broad portfolio of oncology products under development, today announced that the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has cleared its Investigational New Drug (IND) application for eniluracil, which the Company in-licensed from GlaxoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company)
GSK Glycogen Synthase Kinase
GSK Gruppentraining Sozialer Kompetenzen (Germany)
GSK Greenland Shark (FAO fish species code) 
) 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 MBA
abbr.
Master of Business Administration

Noun 1. MBA - a master's degree in business
Master in Business, Master in Business Administration
, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "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, 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 colorectal cancer

Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat.
 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 Liver Cancer Definition

Liver cancer is a relatively rare form of cancer but has a high mortality rate. Liver cancers can be classified into two types.
. 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 Side effects

Effects of a proposed project on other parts of the firm.
, 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. We aim to be a leader in developing innovative treatments that address important unmet medical needs in cancer.We currently have multiple products in the clinical stage of development, including ADH-1 (Exherin(TM)), eniluracil and sodium thiosulfate (STS (Synchronous Transport Signal) The electrical equivalent of the SONET optical signal. In SDH, the European counterpart of SONET, STS is known as STM (Synchronous Transport Module). ). 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 DPD Department of Planning and Development
DPD Dihydropyrimidine Dehydrogenase
DPD Dead Peer Detection (Cisco)
DPD Division of Parasitic Diseases (US CDC)
DPD Dominant Wave Period
DPD Drug Product Database
) 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, please visit our website at www.adherex.com.

This press release contains forward-looking statements that involve significant risks and uncertainties. The actual results, performance or achievements of the Company might differ materially from the results, performance or achievements of the Company expressed or implied by such forward-looking statements.Such forward-looking statements include, without limitation, those regarding the development plans of the Company and the expected timing and results of such development. We can provide no assurance that such development will proceed as currently anticipated or that the expected timing or results of such development will be realized. We are subject to various risks, including those inherent in the biopharmaceutical industry, the early stage of our product candidates, the uncertainties of drug development, clinical trials and regulatory review, our reliance on collaborative partners, our need for additional capital to fund our operations, and our history of losses.For a more detailed discussion of related risk factors, please refer to our public filings available at www.sedar.com and www.sec.gov.

Adherex Technologies Inc. (TSX:AHX) (AMEX:ADH)
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1CANA
Date:Nov 28, 2005
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