Adherex Initiates Asian Phase I/II Trial of Eniluracil in Liver Cancer
Research Triangle Park, NC, September 28, 2006 - - Adherex Technologies Inc. (AMEX:ADH, TSX:AHX), a biopharmaceutical company with a broad portfolio of oncology products under development, today announced the initiation of a Phase I/II trial of the combination of eniluracil and 5-fluorouracil (5-FU) in Asian patients with hepatocellular (liver) cancer. The study will include several sites in Asia and one in the U.S.; the first site activated is in Singapore.
“Liver cancer is one of the most common causes of cancer death in the world and particularly in Asia, yet there are currently no satisfactory treatments,” said Rajesh K. Malik, MD, Adherex’s Chief Medical Officer. “We look forward to studying eniluracil in this patient population and exploring the potential for this new dose and schedule strategy to improve the effectiveness and side effect profile of 5-FU.”
“Where hepatocellular cancer is naturally resistant to 5-FU as a result of its intrinsically high levels of DPD, our combination strategy should allow us to directly inhibit DPD activity with eniluracil and make hepatocellular cancer more susceptible to 5-FU,” said William P. Peters, MD, PhD, Chairman and CEO of Adherex. “From a business perspective, eniluracil represents a significant opportunity for Adherex. 5-FU is currently one of the most commonly prescribed anti-cancer agents in the world, and we would expect the orally active combination of eniluracil + 5-FU to be rapidly adopted by oncologists if we, in fact, see the clinical efficacy and toxicity advantages that we anticipate over 5-FU therapy alone.”
The Phase I dose escalation part of the study, which is expected to enroll approximately 25 patients with hepatocellular cancer, is intended to establish the safety of Adherex’s proprietary dose and schedule of eniluracil + 5-FU in the Asian population. The Phase II part of the study is expected to enroll approximately 25 additional patients and is primarily intended to provide initial efficacy information in this tumor type.
Although hepatocellular cancer is one of the most common tumors in the world, it is less common in the U.S. (with approximately 17,000 new cases per year), providing the opportunity for orphan drug status. In December 2005, Adherex received orphan drug designation from the U.S. Food and Drug Administration for the use of eniluracil in combination with fluoropyrimidines (including 5-FU) to treat hepatocellular cancer.
Adherex is developing eniluracil, an oral dihydropyrimidine dehydrogenase (DPD) inhibitor in-licensed from GlaxoSmithKline in July 2005, to improve the therapeutic value and effectiveness of 5-FU. The Company is currently examining the combination of eniluracil + 5-FU in a U.S. Phase I trial in patients with solid tumors at the Sarah Cannon Cancer Center. That trial is now expected to conclude by the end of 2006, as additional 5-FU dose escalations have been required to define the maximum tolerated dose of the combination. In addition, Adherex is currently conducting a clinical proof-of-mechanism trial at the University of Alabama at Birmingham to confirm that the intended schedule of administration of eniluracil + 5-FU permits the effective activation of 5-FU required for its anti-tumor activity. This proof-of-mechanism trial is also expected to conclude by the end of 2006.
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™), 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, 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 the uncertainties of clinical trials, drug development and regulatory review, our need for additional capital to fund our operations, the early stage of our product candidates, our reliance on collaborative partners, our history of losses, and other risks inherent in the biopharmaceutical industry. For a more detailed discussion of related risk factors, please refer to our public filings available at www.sedar.com and www.sec.gov.
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