PharmaNetics Inc and Aventis Pharmaceuticals jointly announced that a 510K application had been filed for the Rapidpoint ENOX Test, a new diagnostic test designed to analyze therapeutic levels of Aventis Pharmaceuticals' enoxaparin sodium (Lovenox), the number-one selling low-molecular weight heparin (LMWH) in the world.

Under the terms of an agreement signed last year, PharmaNetics will work exclusively with Aventis Pharmaceuticals for a five-year period on an enoxaparin test card. The ENOX test has been calibrated for optimal response to enoxaparin and will be unsuitable for use with other LMWHs. Carrying the trade names and corporate logos of both companies, the card will be labeled and indicated for use as an enoxaparin test.

"We are pleased that our collaboration with PharmaNetics, which makes this technology available to physicians, puts Aventis at the forefront of addressing customer needs and helping to improve patient outcomes," said John Leone, senior vice president and chief operating officer, US Commercial Operations, Aventis Pharmaceuticals. "The application of the Rapidpoint ENOX Test in certain treatment settings will facilitate the appropriate and effective use of Lovenox and strengthen our position in the management of unstable angina."

The next stage of clinical development will be the initiation of a 650-patient study, EvaLuating Enoxaparin Clotting Time (ELECT), to establish the enoxaparin test ranges in which physicians may perform clinical procedures. The study is in its final stages of development.

"Despite a large body of clinical evidence demonstrating that patient outcomes are significantly improved by using Lovenox, many cardiologists remain reluctant to use it in certain treatment settings," said Dr. David Moliterno, lead investigator and associate professor, Cardiovascular Medicine, The Cleveland Clinic. "More than one million people each year are diagnosed with unstable angina, a serious condition that can lead to heart attack and death. The results of this study should help guide physicians in their use of Lovenox and may represent an advance in the treatment of patients with unstable angina."

Enoxaparin was approved in the U.S. and Canada in 1993 and is indicated for the prevention and treatment of deep-vein thrombosis, unstable angina and non-Q wave myocardial infarction. Enoxaparin is marketed under the trade name Lovenox in the United States and the brand names Lovenox, Clexane and Klexane in other parts of the world.

PharmaNetics' technology is uniquely capable of evaluating drugs that influence both clot formation and dissolution and, as such, the Company's strategy is to further expand its menu by developing theranostic tests to assess multiple therapeutic agents. The Company intends to provide physicians with a single platform capable of monitoring numerous antithrombotic therapies, both those on the market as well as those being investigated in the treatment of diseases such as sepsis, stroke, unstable angina, deep vein thrombosis, and pulmonary and arterial emboli.