RALEIGH, N.C., Feb. 5 /PRNewswire/ -- Cardiovascular Diagnostics, Inc.
(Nasdaq: CVDI) announced today that it received a $2.1 million order from the
Knoll AG division of BASF Pharma, the pharmaceutical subsidiary of BASF AG.
The order is for 450 Thrombolytic Assessment System (TAS(TM)) analyzers and
150,000 diagnostic test cards to be used in the Phase III clinical trial for
PEG-Hirudin, Knoll's new thrombin-inhibitor compound.
In December 1996, CVDI and Knoll entered into a collaboration to develop a
rapid diagnostic test for the monitoring of PEG-Hirudin. The ecarin clotting
time (ECT) test combines CVDI's proprietary TAS technology with Knoll's enzyme
technology to produce a test which allows a clinician to manage the dosage of
this therapeutic agent within safe and effective levels. The ECT's speed and
accuracy should enable dosage modifications to be made quickly, an important
advantage over conventional monitoring methods because of the narrow range
between over-and under-dosage of PEG-Hirudin. By fostering optimal
therapeutic effect and thereby minimizing the risk of complications, the ECT
promotes effective, economic patient care.
CVDI's President and Chief Executive Officer, John Funkhouser, said, "This
order demonstrates CVDI's ability to develop rapid tests to monitor next
generation therapeutic drugs and enhance patient outcomes. In addition to
providing tests for routine therapies, CVDI has been increasingly focused on
developing specialty tests which target difficult-to-measure clotting factors
to enable innovative, emerging therapies to be safely and effectively
administered. The 450 TAS analyzers placed in the Knoll trials, in addition
to introducing CVDI's specialty test capability, will be available to
clinicians for CVDI's routine coagulation tests."
Mr. Funkhouser continued, "CVDI's ECT test was designed to be an integral
part of 'best practice' treatment for PEG-Hirudin, thereby linking the success
of the drug and the diagnostic test. By developing specialty tests for major
pharmaceutical firms, CVDI can leverage its technology and accelerate
commercialization and acceptance of its products."
Under the agreement with Knoll, CVDI received exclusive worldwide
licensing rights for diagnostic tests using ecarin, derived from snake venom,
to monitor PEG-Hirudin, as well as other anti-thrombin compounds under
development by other companies. Knoll's PEG-Hirudin is being developed for
cardiovascular indications and as a supplement or replacement for heparin, the
most widely used anti-coagulant or "blood thinner." PEG-Hirudin is the second
compound on which CVDI and Knoll are collaborating. The other drug is Knoll's
Ancrod, being developed to treat ischemic stroke and currently to enter Phase
III trials in Europe and North America.
CVDI's analyzers and diagnostic test cards will be placed in Knoll's
multicenter Phase III clinical trial to investigate the safety and efficacy of
PEG-Hirudin for treating unstable angina. The trial, which is expected to
continue into 1999, will require patients to be monitored with the ECT test up
to eight times during therapy. Unstable angina, which affects nearly
1.8 million people in America and Europe, often precedes myocardial
infarction. It is the leading cause of admission to hospital emergency rooms
and coronary care units.
The initial shipment calls for 225 analyzers and 70,000 test cards to be
delivered by March 31, 1998 and another 225 analyzers delivered by July 1,
1998. CVDI continues to develop rapid diagnostic tests for specific compounds
through additional collaborations with Eli Lilly (for a sepsis drug) and Knoll
(for a stroke therapy drug).
Cardiovascular Diagnostics, Inc. develops, manufactures and markets
systems designed to deliver rapidly and accurately, blood test results at the
point-of-care ("POC"). CVDI's novel technology platform has allowed the
Company to develop a menu of diagnostic tests, including new specialty tests.
The Company believes that its Thrombolytic Assessment System ("TAS")
technology is the only POC system capable of monitoring both the formation and
dissolution of blood clots -- a critical factor in treating heart attacks,
strokes and a variety of other medical conditions.
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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CONTACT: John Funkhouser, President and CEO, or Denise Hobbs, VP, Finance & Administration, both of Cardiovascular Diagnostics, 919-954-9871; or Paula Schwartz, general, 212-661-8030, or Kathy Brunson, analysts, 312-266-7800, both of The Financial Relations Board for Cardiovascular Diagnostics
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