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FOR IMMEDIATE RELEASE
December 20, 1999
PHARMANETICS INITIATES COMPARATIVE STUDIES WITH ECT TEST
Cleveland Clinic And Duke University To Monitor Aventis’ Drug
Raleigh, N.C. (December 20, 1999) – PharmaNetics, Inc. (NASDAQ NM: PHAR), the holding company of Cardiovascular Diagnostics, Inc. ("CVDI"), today announced the initiation of clinical studies comparing its Ecarin Clotting Time (ECT) test with the aPTT test to monitor the effect of Refludan“ (lepirudin), an Aventis S.A. approved direct thrombin inhibitor for use in managing patients suffering with heparin-induced thrombocytopenia (HIT).
The studies are being planned and supported in conjunction with Aventis S.A., the newly merged entity of Germany's Hoechst AG and France's Rhône-Poulenc S.A. Enrollment should begin in February and run through the year at both the Cleveland Clinic and Duke University. PharmaNetics intends to submit study data to the Food and Drug Administration (FDA) for clearance to market the test for use with all patients being treated with Refludan. The ECT test would be the first specifically developed to manage direct thrombin inhibitors.
The aPTT has been widely used primarily in laboratory settings and has been the only test method for physicians and pharmaceutical companies to manage thrombin inhibitors. The aPTT is subject to considerable site-to-site variability, thereby resulting in inaccurate anticoagulation status of some patients when used to assess the effect of a direct thrombin inhibitor, such as Refludan.
Commenting on the proposed study, David Moliterno, M.D., Department of Cardiology, Cleveland Clinic Foundation said, "As more potent anticoagulant therapies are introduced into clinical practice, it is becoming increasingly clear that we need rapid and accurate methods to measure the extent of the anticoagulation from these therapies. We are pleased to be participating in studies aimed at providing these methods and are looking forward to working with PharmaNetics to study other tests under development for drugs such as Low Molecular Weight Heparin."
"Our goal is to demonstrate that the ECT provides physicians with a more reliable and reproducible method with which to manage this group of patients. The ECT test can be performed at the patient’s bedside and may allow the physician to make rapid therapeutic adjustments effecting patient care and outcomes," said Mike Riddle, Executive Vice President of PharmaNetics. "This is the second initiative we have announced recently concerning our ECT test. The first featured the filing of a Humanitarian Device Exemption to obtain clearance for use of the test to measure the effect of Refludan when used to anticoagulate HIT patients undergoing cardiopulmonary bypass surgery."
The ECT is part of a comprehensive menu of tests being developed by the Company to measure the effect of specific anticoagulant therapies. All of the tests can be performed on PharmaNetics’ Thrombolytic Assessment System (TAS), which is marketed under the RapidCoag trademark by Bayer Diagnostics.
PharmaNetics, Inc. develops, manufactures and markets rapid turnaround diagnostics to assess blood clot formation and dissolution. The Company develops tests based on its proprietary, dry chemistry Thrombolytic Assessment System for its principal target market of powerful new drug compounds, some of which may 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 (heart attack), stroke, deep venous thrombosis, and pulmonary and arterial emboli.
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 and dependence on third-party distributors and collaborative partners 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-Q and Form 8-K reports.
Refludan® is an Aventis S.A. product.
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