Adherex Obtains Investigational New Drug 'IND' Clearance From U.S. FDA For Exherin'TM'.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. -- First US clinical trial for Exherin(TM) will proceed Adherex Technologies Inc. (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 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 Exherin(TM), the Company's lead cadherin antagonist, tumor vascular targeting compound; this means the Company is able to commence a U.S.-based, Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I of Exherin(TM). The study will take place under the direction of David J. Stewart, MD, professor in the Department of Thoracic/Head and Neck Medical Oncology at The University of Texas M.D. Anderson Cancer Center in Houston. "Vascular targeting is a novel approach to cancer treatment," said Dr. David Stewart, Principal Investigator for the study. "This type of rationally developed, molecularly targeted therapy is a novel strategy and may offer cancer patients new hope. The study is designed to evaluate the safety and drug metabolism of the agent as well as to look at the drug's activity on the tumor and its vasculature vasculature /vas·cu·la·ture/ (vas´ku-lah-chur) 1. circulatory system. 2. any part of the circulatory system. vas·cu·la·ture n. ." This will be the first clinical study of Exherin(TM) in the U.S. In addition to further exploring the tolerability and pharmacokinetics of the drug, the clinical study will use Dynamic-MRI imaging techniques to assess the time-course of activity of Exherin(TM) on a patient's tumor and its blood supply. The study is expected to begin in July and will enroll up to 20 patients. Exherin(TM) is a novel tumor vascular targeting agent and is a small peptide molecule that specifically disrupts the blood vessels of cancers through inhibition of the cell adhesion protein, N-cadherin, that is a critical structural component of some tumor blood vessels. Early results from the first clinical trial of Exherin(TM), being conducted at the Ottawa Regional Cancer Centre The Regional Cancer Centre(RCC), was established in 1981 by the Government of Kerala and Government of India at Thiruvananthapuram(Trivandrum), the capital of Kerala. The RCC deals with the treatment of Cancer in the states of Kerala, Tamil Nadu and Karnataka. (ORCC ORCC Ohio Regional Campus Conference ORCC Outwardly Rectifying Chloride Channel ORCC Ottawa Regional Cancer Center ORCC Old Roman Catholic Church ORCC Online Resources & Communications Corporation (now named Online Resources Corporation) ), were recently reported at the ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company (American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. ) meeting in New Orleans. These data indicated safety through a range of six dose levels used to date and encouraging hints of biological activity in two patients. The studies at the M.D. Anderson and at ORCC will coordinate their efforts to determine the maximum tolerated dose and evaluate the dose related pharmacology of Exherin(TM). "It was a critical event for Adherex to begin its dialogue with the FDA about Exherin(TM), and the fact that we can proceed with this next clinical trial following clearance of our IND application by the FDA is another very important milestone for Adherex," said Dr. William P. Peters, Chairman and Chief Executive Officer of Adherex. "We are particularly delighted to have a significant oncology opinion leader in Dr. David Stewart serving as the Principal Investigator and to be conducting the study at one of the world's most respected cancer centers - the M.D. Anderson. While drug development is inherently uncertain, having top-tier investigators and centers involved offers Adherex the best chance of success. The development of a novel agent like Exherin(TM) requires investigational excellence. The skills and resources available at the M.D. Anderson will be an important contributor to the overall plans and programs that we have been putting in place for Exherin(TM) in 2004." About Adherex Technologies Adherex Technologies Inc. is a biopharmaceutical company with a broad portfolio of products under development. Four products are in clinical development including Exherin(TM), Adherex's lead cadherin antagonist compound, and 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). , a drug that protects against severe hearing loss that is often produced by platinum-based anticancer agents. Adherex's intellectual property includes broad, interlocking interlocking /in·ter·lock·ing/ (-lok´ing) closely joined, as by hooks or dovetails; locking into one another. interlocking Obstetrics A rare complication of vaginal delivery of twins; the 1st protection for cadherin-mediated adhesion and represents what the Company believes to be the world's broadest portfolio of vascular targeting and cell adhesion modulating agents. The Company has offices in Research Triangle Park, North Carolina and Ottawa, Canada. For more information, please visit Adherex's website at www.adherex.com This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Certain information contained in this news release is forward-looking and is subject to unknown risks and uncertainties. The actual results, performance or achievements of the Company may differ materially from the results, performance or achievements of the Company expressed or implied by such forward-looking statements. |
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