Adherex Technologies Inc.
TSX : AHX
AMEX : ADH

Adherex Technologies Inc.

November 08, 2006 09:26 ET

Clinical Data From Adherex's Proof-of-Mechanism and Phase I Eniluracil Trials to be Presented at November 8th Analyst and Investor Meeting

Presentations on ADH-1 Also on Meeting Agenda

RESEARCH TRIANGLE PARK, NORTH CAROLINA--(CCNMatthews - Nov. 8, 2006) - Adherex Technologies Inc. (TSX:AHX)(AMEX:ADH), a biopharmaceutical company with a broad portfolio of oncology products under development, today announced that updated clinical data from its proof-of-mechanism trial for eniluracil as well as its Phase I trial of eniluracil + 5-fluorouracil (5-FU) in solid tumors will be presented tonight by Adherex clinical investigators at the Analyst and Investor Meeting scheduled for 5-7 p.m. in New York City. The meeting will also feature presentations on Adherex's Phase I single-agent trials of ADH-1 as well as the preclinical studies of ADH-1 in combination with chemotherapy. The Analyst and Investor Meeting will be available via live and replay webcast at www.adherex.com.

Dr. Robert B. Diasio, Professor, Department of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic College of Medicine and Director, Mayo Clinic Cancer Center, will present updated data from the clinical proof-of-mechanism trial on three patients who received a single, oral dose (2, 5 or 10 mg) of eniluracil 12 to 14 hours prior to surgery for colorectal cancer. At the time of surgery, a biopsy sample of tumor tissue and healthy surrounding tissue was collected from the patients for an analysis of the activity of dihydropyrimidine dehydrogenase (DPD), which is responsible for the breakdown 5-FU, and the anabolic enzymes required to activate 5-FU into an effective anti-cancer agent. Blood was also collected to assess the inhibition of DPD. As expected, 12 to 14 hours after administration of all three doses of eniluracil, DPD activity was inhibited and the anabolic enzymes were active. These data confirm directly in tumor tissue that Adherex's planned dose and schedule is appropriate for the combination of eniluracil + 5-FU.

Dr. Howard A. Burris, Director of Drug Development, Sarah Cannon Research Institute, will present clinical data on 16 patients enrolled to date in the Phase I trial of eniluracil + 5-FU. In this study, patients resistant to a variety of previous chemotherapy treatments, including 5-FU and other fluoropyrimdines, received a 5 mg dose of eniluracil followed 12 to 20 hours later by a dose of 5-FU (in escalating cohorts of 30, 40, 50, 60 or 70 mg). In the 13 patients for whom DPD results are presently available, DPD was inhibited at the time of 5-FU dosing, as expected. Orally administered 5-FU had an extended half-life of approximately 3.5 hours as compared to intravenous 5-FU, which has a half-life of approximately 20 minutes. A maximum tolerated dose (MTD) of 5-FU in combination with eniluracil has yet to be determined. These results confirm in patients that Adherex's dose and schedule of eniluracil + 5-FU effectively inhibits DPD activity, extends the half-life of 5-FU and allows for an orally-administered dose of 5-FU. Further, taking the data together from both studies provides confirmation of each element of Adherex's hypothesis for the optimal way to combine of eniluracil + 5-FU.

Dr. William P. Peters, Adherex's Chairman and CEO, will present and review the combined results from Adherex's two Phase I single agent studies of ADH-1, which demonstrated that ADH-1 was well tolerated and showed acceptable pharmacokinetics and evidence of molecularly-appropriate anti-tumor activity in seven patients with N-cadherin positive tumors.

Dr. Douglas S. Tyler, Professor of Surgery and Chief, Section of Surgical Oncology, Duke University Medical Center and Chief, Surgery Service, Durham VA Medical Center, will review results of preclinical studies of ADH-1 in combination with chemotherapy. In one animal melanoma model, Dr. Tyler found that, in contrast to melphalan alone where approximately half of the animals had a transient tumor response, every animal experienced complete remission of its tumor following administration of systemic ADH-1 plus regionally administered melphalan. When the combination was studied in animals with tumors resistant to melphalan alone, approximately half of the animals experienced major regressions of their tumors, whereas melphalan alone was completely ineffective. A Phase I trial of regional melphalan plus ADH-1 in melanoma is expected to begin as soon as possible.

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 activities. We can provide no assurance that such development plans will proceed as currently anticipated or that the expected timing or results of such plans will be realized. We are subject to various risks, including the uncertainties of clinical trials, our need for additional capital to fund our operations, drug development and regulatory review, our reliance on collaborative partners, the early stage of our product candidates, 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.

Contact Information

  • Adherex Technologies Inc.
    Melissa Matson
    Director, Corporate Communications
    919-484-8484
    matsonm@adherex.com