RALEIGH, N.C., Feb. 20 /PRNewswire/ -- 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(TM)) 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(TM) analyzers and cards in critical care settings."
Ancrod, sold by Knoll under the name ARVIN(TM), 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(TM) 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(TM)) 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.
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.
SOURCE Cardiovascular Diagnostics, Inc.
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Related links: http://www.frbinc.com
CONTACT: John Funkhouser, President, CEO, or Paul Storey, Director of Finance, for Cardiovascular Diagnostics, 919-954-9871; or General Info: Paula Schwartz, 212-661-8030, or Analyst Info: Kathy Brunson, 312-266-7800, both of The Financial Relations Board for Cardiovascular Diagnostics
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