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AT THE COMPANY:
John Funkhouser, President, CEO
Paul Storey, Director of Finance
(919) 954-9871
AT THE FINANCIAL RELATIONS BOARD
General Info: Paula Schwartz (212) 661-8030
Analyst Info: Kathy Brunson (312) 266-7800
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FOR IMMEDIATE RELEASE
February 20, 1998
CARDIOVASCULAR DIAGNOSTICS TO RECEIVE SECOND MILESTONE PAYMENT FROM KNOLL FOR ANCROD STROKE TREATMENT TEST DEVELOPMENT
Raleigh, NC - February 20, 1998 -- Cardiovascular Diagnostics, Inc. (Nasdaq:CVDI) today announced that Knoll AG has agreed to provide another $250,000 for further development of CVDI's Low Range Fibrinogen (LRF) Test. The agreement follows the successful demonstration of feasibility in field trials of CVDI's point-of-care diagnostic for the measurement of fibrinogen concentration in patients treated with ancrod. The additional funds will be used to complete the development of CVDI's test card, which is read by CVDI's standard Thrombolytic Assessment System (TAS) analyzer.
"CVDI's alliance with Knoll underscores the benefits of developing specialty tests in concert with the development of therapeutic agents for clotting and lysis," said John Funkhouser, President and Chief Executive Officer of CVDI. "Timely and accurate readings of fibrinogen are needed to adjust the ancrod dosage level to achieve optimal therapeutic benefits. CVDI's test, therefore, should contribute to the commercial acceptance of the therapy. In turn, successful commercialization of the drug will support the placement of TAS analyzers and cards in critical care settings."
Ancrod, sold by Knoll under the name ARVIN, has been used widely in Europe for the treatment of vascular disease and deep venous thrombosis. Derived from snake venom, ancrod's effects include reducing blood viscosity by lowering fibrinogen levels. A Phase III clinical trial of ancrod to treat stroke is ongoing, with patient enrollment to continue into 1999. Knoll expects to release preliminary results of its Phase III clinical trial, known as the European Stroke Treatment with Ancrod Trial (ESTAT), in the next few months.
Stroke is the third leading cause of death in North America and Europe, afflicting over one million patients each year. In addition, it is a common cause of chronic disability. The cost of stroke treatment and rehabilitation has been estimated to exceed $20 billion annually. In over 80 percent of the cases, stroke is attributed to cerebral thrombosis, or ischemia, which is the condition targeted by ancrod.
Earlier this month, CVDI received an order to supply TAS analyzers and Ecarin Clotting Time (ECT) test cards for Knoll's Phase III trial of PEG-Hirudin, a new thrombin inhibitor for the treatment of unstable angina. Two 510 (k) applications were submitted to the FDA in February for the ECT test and ECT controls.
Cardiovascular Diagnostics, Inc. develops, manufactures and markets rapid turnaround, point-of-care diagnostics to assess blood clot formation and dissolution. CVDI develops tests based on its proprietary, dry chemistry Thrombolytic Assessment System (TAS) for powerful new therapeutics with narrow ranges between over- and under-dosage, which represent CVDI's principal target market, as well as for monitoring routine anticoagulants. CVDI is collaborating on diagnostics for drugs in clinical trials with Eli Lilly, for a sepsis marker, and with Knoll AG, for PEG-Hirudin and ancrod. CVDI's therapeutic diagnostics are used in the treatment of angina, myocardial infarction (heart attack), stroke, deep venous thrombosis, and pulmonary and arterial emboli.
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To receive CVDI's latest news release and other corporate documents via FAX- no cost- dial 1-800-PRO-INFO. Use company's ticker, CVDI. Or visit The Financial Relations Board's web site at http://www.frbinc.com.
This press release contains forward-looking statements regarding future events and the future performance of Cardiovascular Diagnostics that involve risks and uncertainties that could cause actual results to differ materially from those projected in the forward-looking statements. Information concerning 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.
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