SAN DIEGO, May 13 /CNW/ -- Accumetrics, Inc. announces that it has
enrolled its 1,000th patient into its landmark clinical trial, GRAVITAS
(Gauging Responsiveness with A VerifyNow(R) Assay Impact on Thrombosis And
Safety). The trial is specifically designed to demonstrate the value of
providing clinicians with actionable information for patients who are poor
responders to clopidogrel (Plavix(R)). The multi-center, placebo controlled
trial will determine whether tailored antiplatelet therapy for poor
responders, identified based on the results of the company's VerifyNow P2Y12
Test, reduces major cardiovascular adverse events (e.g., heart attack, stent
thrombosis) following percutaneous coronary intervention (PCI). Currently the
trial is being conducted at more than 70 sites in the U.S. and Canada, with a
total enrollment goal of approximately 2,800 patients.
"This is a very significant milestone for Accumetrics as it brings us
ever-closer to our goal of demonstrating the value of the VerifyNow System. By
identifying and adjusting therapy for patients that are not responding
adequately to standard doses of clopidogrel, GRAVITAS will be the largest
multi-center clinical trial that links testing with personalized medicine and
improved outcomes. We believe that the VerifyNow System will be seen as an
integral tool in ensuring that patients receive not only the most appropriate
antiplatelet therapy, but also the adequate dose," said Jeff Dahlen, Ph.D,
Vice President, Clinical and Regulatory Affairs of Accumetrics, Inc. "We are
very proud to reach this milestone, and look forward to completing enrollment
soon, and sharing the results."
The concept of variability in response to antiplatelet therapy has been
well established. The question of whether poor response to antiplatelet
therapy, as measured by a laboratory test, leads to poor outcomes is also
being demonstrated with increased frequency. However, Accumetrics recognizes
the need for a study specifically designed to demonstrate the value of
providing clinicians with actionable information to improve outcomes for those
patients who are poor responders to antiplatelet therapy. As a result, the
GRAVITAS study is the first multi-center, placebo-controlled study to
determine whether tailored antiplatelet therapy based on the results of the
company's VerifyNow System reduces major cardiovascular adverse events
About Accumetrics (www.accumetrics.com)
Accumetrics is committed to advancing medical understanding of platelet
function and enhancing quality of care for patients receiving antiplatelet
therapies by providing industry-leading and widely accessible diagnostic tests
for rapid platelet function assessment.
Accumetrics' VerifyNow System is the first rapid and easy to use platform
for measuring an individual's response to multiple antiplatelet agents.
Addressing every major antiplatelet drug, including FDA-cleared products for
aspirin, Plavix, ReoPro(R), and Integrilin(R), the VerifyNow System provides a
valuable tool to help physicians make informed treatment decisions.
The Accumetrics logo and VerifyNow are registered trademarks of
Accumetrics, Inc., Plavix is a registered trademark of Sanofi-Aventis, ReoPro
is a registered trademark of Centocor, Inc., and Integrilin is a registered
trademark of Millennium Pharmaceuticals.
Lippert/Heilshorn & Associates
Timothy I. Still
President and CEO
For further information:
For further information: Jules Abraham of Lippert/Heilshorn &
Associates, +1-212-838-3777, email@example.com, for Accumetrics; or Timothy I.
Still, President and CEO of Accumetrics, +1-858-404-8260,
firstname.lastname@example.org Web Site: http://www.accumetrics.com