Adherex Initiates Clinical Trial Program for ADH-1 in Combination with Chemotherapy
- - Study to explore ADH-1 in combination with docetaxel, carboplatin or capecitabine - -
Research Triangle Park, NC, October 3, 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 trial of ADH-1 in combination with chemotherapy in conjunction with the US Oncology Research network. The trial will be offered at 10 sites in the network’s innovative Translational Oncology Phase 1 Research program chaired by Daniel D. Von Hoff, MD, US Oncology’s Chief Scientific Officer.
“ADH-1’s molecular target, N-cadherin, is a novel and intriguing therapeutic target, one that is increasingly being recognized as an integral part of the process through which cancers become more invasive and metastatic,” said Robert N. Raju, MD, Dayton Oncology & Hematology – Kettering in Ohio, a member of the US Oncology network, and principal investigator of Adherex’s ADH-1 Phase I combination trial. “ADH-1 has been well tolerated in clinical studies thus far, and we look forward to exploring its potential synergistic activity with some commonly-used chemotherapies.”
“Recent preclinical data have shown that the combination effects of chemotherapy and ADH-1 are dramatically enhanced and unpredicted compared to the results of either agent alone, and achieved without increased toxicity,” said William P. Peters, MD, PhD, Chairman and CEO of Adherex. “These preclinical observations have stimulated the rapid initiation of combination studies of chemotherapy with ADH-1 in patients. If ADH-1 is able to enhance chemotherapy’s anti-tumor activity in the clinic, the market opportunity for ADH-1 becomes even more significant. Modern oncology almost always uses combination therapy, and we believe that ADH-1 will be most easily incorporated into the current treatment framework as a combination with either chemotherapeutic agents or other biologics. Today’s announcement represents a major first step in advancing its development further along these lines.”
This Phase I dose escalation study is intended to define the dose limiting toxicities and maximum tolerated dose of ADH-1 in three separate combinations (in effect, three separate sub-studies): ADH-1 + docetaxel (Taxotere®), ADH-1 + carboplatin, and ADH-1 + capecitabine (Xeloda®). Docetaxel is currently used in the treatment of breast cancer, prostate cancer and non-small cell lung cancer, among others. Carboplatin is commonly used in the treatment of ovarian and lung cancer. Capecitabine is currently used to treat breast and colon cancer. Preliminary evidence of anti-tumor activity will also be monitored. The Company expects to enroll an aggregate of up to 55 patients with N-cadherin positive solid tumors among the three arms of the trial.
Adherex’s clinical development program for ADH-1 also includes an ongoing single agent Phase II trial, which is evaluating the anti-tumor activity and tolerability of repeated doses of ADH-1 at six sites in Canada and three sites in the U.S. That study, which is anticipated to conclude patient enrollment by the end of 2006, is studying ADH-1 in patients with lung, esophageal, adrenocortical, kidney or liver cancers whose tumors express the molecular target, N-cadherin. The Company is also conducting a Phase II single agent study of ADH-1 in Europe, which is enrolling patients with N-cadherin positive ovarian or lung cancer and is also expected to complete patient enrollment by the end of 2006. The Company also has plans to conduct a clinical study of ADH-1 in combination with melphalan for the treatment of melanoma, with the trial expected to begin later this year.
About US Oncology Research
The US Oncology Research network is an established community-based research operation specializing in Phase I – IV cancer clinical trials, and includes research studies in translational oncology and bone marrow transplant. The “ADH-1 in Combination with Chemotherapy” trial will be offered at 10 sites approved for Phase 1 research: Dayton Oncology & Hematology, Ohio; New York Oncology Hematology; Virginia Oncology Associates; Cancer Centers of the Carolinas, SC; Ocala Oncology, Fla., Central Indiana Cancer Centers; Texas Oncology – Tyler Cancer Center; Texas Oncology-Sammons Cancer Center; Rocky Mountain Cancer Centers, CO, and Northwest Cancer Specialists, OR.
The US Oncology Research network currently has 536 research physicians actively enrolling patients, 88 research sites, and is currently involved in 72 open research trials. The network has contributed to the development of 23 of 29 of the latest cancer-fighting drugs approved by the Food and Drug Administration for use. Since 1993, 30,000 patients have participated in clinical trials managed by US Oncology network practices. US Oncology is one of the nation’s largest cancer treatment and research networks. For more information, visit www.usoncology.com.
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.
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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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