New CHARISMA Outcome Study Results Validate Aspirin Effect
21 Oktober 2008 - 3:15PM
PR Newswire (US)
Corgenix Medical's AspirinWorks(R) Test could change how millions
worldwide are tested for aspirin effect and treated for heart
disease DENVER, Oct. 21 /PRNewswire-FirstCall/ -- Corgenix Medical
Corporation (OTC:CONX) (BULLETIN BOARD: CONX) announces that new
CHARISMA trial findings published in Circulation confirm that
elevated urinary levels of the biomarker 11-dehydro thromboxane B2
(11dhTxB2) indicate an increased risk of heart attack, stroke and
cardiac death. The AspirinWorks(R) Test by Corgenix is the only
FDA-cleared test that measures urinary 11dhTxB2 to accurately
determine aspirin effect in apparently healthy individuals.
11dhTxB2 is a metabolite of thromboxane, the target of aspirin
therapy. The new findings, published in the October 21 issue of the
American Heart Association's peer-reviewed medical journal
Circulation, directly link increased levels of this powerful
biomarker to a patient's risk of heart attack and stroke,
potentially changing how millions of people worldwide are tested
for aspirin effect and treated to prevent heart attacks and
strokes. The sub-study of the Clopidogrel for High Atherothrombotic
Risk and Ischemic Stabilization, Management and Avoidance
(CHARISMA) trial was carried out with the pre-FDA-cleared version
of the AspirinWorks Test. The test subsequently received FDA
clearance in May 2007 and is available worldwide. Cardiologist Paul
A. Gurbel, M.D., Director, Sinai Center for Thrombosis Research at
Sinai Hospital of Baltimore, said the study supports that
measurement of urinary 11-dehydro thromboxane B2 can identify
patients at risk for ischemic events and can be used as an
independent risk factor for heart disease and stroke.
"Interestingly, the investigators observed a dose-dependent effect
of aspirin on levels of this marker," explained Gurbel. "These data
are consistent with our previous randomized data from the double
crossover ASPECT study that evaluated the effect of three commonly
used aspirin doses published last year in Circulation. We also
found a reduction in 11-dehydro thromboxane B2 between 81 mg and
325 mg. "These findings strongly support the role of urinary
11-dehydro thromboxane B2 concentrations as an independent
predictor of cardiovascular risk in aspirin-treated patients," said
Gurbel. "The findings of both the ASPECT study and current
investigation also raise the potential for adjusting aspirin doses
to modify risk by reducing in vivo thromboxane synthesis." CHARISMA
is a multinational, multicenter, randomized, parallel group,
double-blind trial involving 15,603 patients with either clinically
established cardiovascular disease or multiple risk factors. The
pre-specified CHARISMA sub-study involved a total of 3,261
aspirin-treated patients from 224 sites in 12 countries. Among the
principal findings was that the upper quartile of urinary 11dhTxB2
concentration in a broad population of high-risk patients treated
with usual doses of aspirin (75 to 325 mg) was independently
associated with an increased risk of serious cardiovascular events.
Other findings from the trial include: 1) Aspirin and statin
treatment were associated with lower concentrations of 11dhTxB2. 2)
Randomization to clopidogrel (vs. placebo) did not reduce urinary
11-dehydro thromboxane B2 levels nor did it reduce the hazard of
cardiovascular events in patients in the highest quartile of
urinary 11dhTxB2 levels. "This is the outcome study we have all
been waiting for because it demonstrates the potential value of the
AspirinWorks test (11dhTxB2) for optimizing an individual's aspirin
therapy. The publication of these findings in one of the most
prestigious medical journals further demonstrates the value and
viability of the AspirinWorks product," said Douglass Simpson,
Corgenix' President and Chief Executive Officer. "The ability to
quickly, easily and accurately determine the effect of aspirin in
patients gives the AspirinWorks test a strong and unique position
in the U.S. and global cardiovascular diagnostic testing market
place." For more information on AspirinWorks, visit
http://www.aspirinworks.com/. To access the full Circulation
article, go to: http://circ.ahajournals.org/. Physicians and
laboratories interested in ordering the test can call
1-800-729-5661 x180, or e-mail: . The AspirinWorks Test is also
available directly to consumers through HealthCheckUSA at
http://www.healthcheckusa.com/. About Corgenix Medical Corporation
Corgenix is a leader in the development and manufacturing of
specialized diagnostic kits for immunology disorders, vascular
diseases and bone and joint disorders, including the world's only
non-blood-based test for aspirin effect. Corgenix diagnostic
products are commercialized for use in clinical laboratories
throughout the world. The company currently sells over 50
diagnostic products through a global distribution network and has
significant experience advancing products through the FDA process.
More information is available at http://www.corgenix.com/.
Statements in this press release that are not strictly historical
facts are "forward looking" statements (identified by the words
"believe", "estimate", "project", "expect" or similar expressions)
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements inherently involve risks and
uncertainties that could cause actual results to differ materially
from the forward-looking statements. Factors that would cause or
contribute to such differences include, but are not limited to,
continued acceptance of the Company's products and services in the
marketplace, competitive factors, changes in the regulatory
environment, and other risks detailed in the Company's periodic
report filings with the Securities and Exchange Commission. The
statements in this press release are made as of today, based upon
information currently known to management, and the Company does not
undertake any obligation to publicly update or revise any
forward-looking statements. DATASOURCE: Corgenix Medical
Corporation CONTACT: William Critchfield, Senior VP and CFO of
Corgenix Medical Corporation, +1-303-453-8903, ; or media, Dan
Snyders, Vice President and Public Relations Supervisor of Armada
Medical Marketing, +1-303-623-1190, ext. 230, fax, +1-303-623-1191,
, for Corgenix Medical Corporation Web site:
http://www.corgenix.com/
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