Duke Clinical Research Institute and PharmaNetics Sign Collaborative Agreement to Expand Use of Theranostic Tests.RALEIGH, N.C.--(BW HealthWire)--Dec. 7, 1999-- PharmaNetics, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on NM: PHAR), the holding company of Cardiovascular Diagnostics, Inc., today announced that the Company has signed a two-year agreement with Duke Clinical Research Institute ("DCRI DCRI Direction Centrale du Renseignement Intérieur DCRI Duke Clinical Research Institute DCRI Diversified Corporate Resources, Inc. DCRI Dental & Cosmetic Research Institute (India) DCRI Data Center Reference Implementations "), a subsidiary of the Duke Medical Center ("Duke"), making PharmaNetics the preferred provider of rapid point-of-care technology for anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting). compounds used in clinical trials at the DCRI. Duke also will collaborate with the Company to investigate additional applications of the Thrombolytic thrombolytic /throm·bo·lyt·ic/ (throm?bo-lit´ik) dissolving or splitting up a thrombus, or an agent that so acts. thrombolytic 1. dissolving or splitting up a thrombus. 2. an agent that dissolves or splits up a thrombus. Assessment System (TAS TAS abbr. 1. telephone answering system 2. true airspeed ) in managing new therapies. For certain indications and therapeutics, managing anticoagulation can reduce bleeding complications and, thus, improve patient outcomes. Under the terms of this agreement, in its role as coordinator of global multi-center clinical studies the DCRI will refer the PharmaNetics technology to any pharmaceutical company initiating clinical trials for developmental anticoagulants Anticoagulants Drugs that suppress, delay, or prevent blood clots. Anticoagulants are used to treat embolisms. Mentioned in: Embolism, Heart Valve Replacement that DCRI determines require monitoring. PharmaNetics will develop a rapid management tool for the compound and will provide the test for use during and after the clinical trial process. In addition, PharmaNetics will be working with the DCRI to provide additional tests for approved anticoagulants used in certain indications or on certain subsets of "at risk" patients. "Physicians have contacted us on numerous occasions to develop tests that enable them to more adequately manage some of the new anticoagulants being marketed. This significant collaboration with Duke further validates our technology and our ability to deliver a comprehensive coagulation coagulation (kōăg'y lā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or solution for patient care and management," stated John Funkhouser, president and chief executive officer of PharmaNetics. "This agreement brings together PharmaNetics' expertise in theranostics and Duke's clinical expertise and reputation for excellent patient care. In combining these strengths along with the PharmaNetics TAS technology, we expect to provide physicians with new rapid diagnostic management tools." With this agreement, PharmaNetics is seeking to actively involve the physician in the determination of how therapeutics affecting coagulation will be managed. Scott Berkowitz, M.D., Associate Professor of Medicine and Pathology at Duke University, stated, "As we expand the indications for use and gain experience with new generations of anticoagulant compounds, it has become very apparent that there are subsets of patients for whom monitoring is necessary." Dr. Berkowitz continued, "Working with PharmaNetics to develop, assess the value of, and gain regulatory approval for these tests, we hope to provide physicians with a rapid means to measure the effectiveness of the drug, adjust the therapy, and improve patient outcomes." The Company anticipates that it will enter into other such collaborations as the pipeline of new anticoagulants continues to grow and the indications for use are expanded, adding that the willingness of physicians to work with PharmaNetics in developing these tests clearly demonstrates an unmet clinical need. In commenting on this announcement, Mike Riddle, executive vice president of PharmaNetics, stated, "This agreement provides us with the opportunity to utilize DCRI's extensive experience in clinical trial development as, together, we initiate a number of projects targeted at demonstrating the substantial benefit gained by monitoring patients being treated with new anticoagulant therapies." The Company and the DCRI expect to begin planning clinical studies immediately with two of its new tests to monitor low molecular weight heparins, which represent an estimated $800 million annual market opportunity, and Refludan(R), a thrombin inhibitor Thrombin inhibitor Thrombin inhibitors are one type of anticoagulant medication, used to help prevent formation of harmful blood clots in the body by blocking the activity of thrombin. Mentioned in: Anticoagulant and Antiplatelet Drugs . In addition, negotiations have been initiated with a pharmaceutical company referred by Duke, to develop a test for use in multi-center clinical studies. The studies are currently in the planning stages. PharmaNetics, Inc. develops, manufactures and markets rapid turnaround diagnostics to assess blood clot blood clot n. A semisolid, gelatinous mass of coagulated blood that consists of red blood cells, white blood cells, and platelets in a fibrin network. formation and dissolution. The Company develops tests based on its proprietary, dry chemistry Thrombolytic Assessment System for its principal target market of new drug compounds, some of which have narrow therapeutic ranges, as well as for monitoring routine anticoagulants. The Company's therapeutic diagnostics are used to monitor the effect of antithrombotic agents in the treatment of angina, myocardial infarction myocardial infarction: see under infarction. (heart attack), stroke, deep venous thrombosis deep venous thrombosis n. Abbr. DVT A condition in which one or more thrombi form in a deep vein, especially in the leg or pelvis, resulting in an increased risk of pulmonary embolism. , and pulmonary and arterial emboli emboli /em·bo·li/ (em´bo-li) plural of embolus. Emboli Plural of embolus. An embolus is something that blocks the blood flow in a blood vessel. . This press release contains forward-looking statements regarding future events and the future performance of PharmaNetics that involve risks and uncertainties, such as risks related to market acceptance, clinical trials, dependence on third-party distributors and collaborative partners, and continuing losses that could cause actual results to differ materially from those projected in the forward-looking statements. Information concerning these and other of the factors that could cause actual results to materially differ from those in the forward-looking statements is contained in the Company's SEC filings, including Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , Form 10-Q and Form 8-K reports. |
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