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| |  Cardiovascular Dx, Knoll To Develop New Treatment For Ischemic Stroke RALEIGH, N.C., May 8, 1997 -- Cardiovascular Diagnostics, Inc., today announced that it has signed a development and co-marketing agreement with Knoll AG of Ludwigshafen, Germany -- the pharmaceutical subsidiary of BASF. Under the agreement, CVDI will be for use of its proprietary dry chemistry technology (the Thrombolytic Assessment System, or TAS(TM)), to develop a rapid, point-of-care ("POC") test to monitor treatment of ischemic stroke with Knoll's new agent, Ancrod, currently in clinical trials in Europe and North America. Ancrod, a purified component developed from the venom of the Malayan pit viper (Agkistrodan rhodostoma), removes fibrinogen (a natural protein which augments clot formation) from the blood. More than two million people in the United States and Europe are afflicted by a stroke each year. Approximately 80% of these cases are caused by a blood clot, or ischemia. Because Ancrod is a powerful drug which can reduce the level of fibrinogen to the point of potentially causing bleeding, a rapid diagnostic test is needed to help the physician maintain the patient's fibrinogen at a safe, but effective level. CVDI's flexible TAS technology platform provides rapid and accurate bedside monitoring -- giving physicians the diagnostic tools to control drug dosing within a narrow therapeutic range. The Company believes that in order to accurately monitor a patient undergoing treatment with Ancrod, physicians will need to use between five and 10 of its TAS test cards. CVDI has already developed another test card for Knoll which is in use in clinical trials to monitor Knoll's proprietary anticoagulant drug, PEG-Hirudin -- used primarily in cardiovascular procedures. To date, CVDI has sold more than 50 TAS analyzers and 30,000 test cards to Knoll for use in its initial Phase II drug trials. Knoll expects to significantly expand these anticoagulant trials this Fall. Developing an additional card for another Knoll therapeutic is an extension of CVDI's ongoing collaboration strategy to provide rapid bedside monitoring to improve therapeutic efficacy. Commenting on this newly signed agreement, Dr. Norbert Bender, Vice President of Research and Development, Cardiovascular Division at Knoll AG, said, "In developing a rapid diagnostic test for Ancrod, it was natural for Knoll to turn to CVDI because of the Company's success in developing an Ecarin Clotting Time (ECT) Test card for monitoring another Knoll AG therapeutic initiative, PEG-Hirudin. If a compound has a short half-life or a narrow therapeutic window, then without proper monitoring, the physician could be at risk of over-or under-dosing the patient. This is why a rapid bedside monitoring method is critical, and CVDI's TAS monitoring method has proven a good rapid diagnostic platform in the past." John Funkhouser, CVDI's Chief Executive Officer, noted "Proper monitoring of drugs which exert powerful effects on the patient's coagulation system, require POC tests which allow the physician to regulate drug therapy to changing patient conditions on a timely basis. This should result in improved efficacy and reduced health care costs. This is especially true with ischemic stroke, which is a devastating illness with far-reaching health care costs." Management went on to say that the test for monitoring Acrod's effect on fibrinogen may also be useful in developing another test to monitor the level of fibrinogen during lengthy surgical procedures such as heart bypass, and for determining fibrinogen levels for diagnosis of blood coagulation disorders. CVDI's novel technology platform will enable the development of a comprehensive menu of diagnostic tests and enables rapid development of new specialty tests capable of monitoring both the coagulation (formation) and lysis (dissolution) drugs, which are used in the treatment of heart attacks and strokes, and in a variety of other medical procedures.
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