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Case Series in Journal of Invasive Cardiology Describes the Role of PharmaNetics' ENOX Test in Managing Four Patients Treated with Enoxaparin.


Business Editors/Health/Medical Writers

RALEIGH, N.C.--(BUSINESS WIRE)--July 21, 2003

Highlights Usefulness of ENOX and Enoxaparin in the

Management of Patients with Acute Coronary Syndromes

The series, submitted by Dr. Jose G. Diez, Assistant Professor of Medicine, Director Interventional Cardiology Research, and colleagues at Tulane University Health Sciences Center, New Orleans, was presented in the July 2003 issue of the Journal of Invasive Cardiology and further validates the value of PharmaNetics' ENOX test in detecting the anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting).  effects of enoxaparin in patients who undergo percutaneous coronary intervention Percutaneous coronary intervention (PCI), commonly known as coronary angioplasty or simply angioplasty, is a therapeutic procedure to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease.  (PCI (1) (Payment Card Industry) See PCI DSS.

(2) (Peripheral Component Interconnect) The most widely used I/O bus (peripheral bus).
). The cases describe various treatment strategies for managing acute coronary syndromes (ACS (Asynchronous Communications Server) See network access server. ) patients with enoxaparin using the test to confirm that the patients were adequately anticoagulated. Using various dosing strategies, all patients eventually achieved ENOX clotting times of greater than 260 seconds and successfully underwent PCI, illustrating the tests' usefulness in helping physicians achieve the ideal level of anticoagulation. As with an earlier case reported in May by Dr. Sai See Statement of Additional Information.  Sadanandan and colleagues at Oklahoma University Health Sciences Center, it further describes the importance of the ENOX test when used to monitor the enoxaparin level in patients who may not have achieved steady-state levels of anticoagulation with subcutaneous dosing (i.e. more than three doses or, according to the studies by Collet et al and the PEPCI PEPCI Protocol for Exchange of Policy Information  investigators, at least four subcutaneous doses).

Commenting on the use of the test, Dr. Diez said, "Enoxaparin has been demonstrated to be superior in the medical and upstream management of ACS patients. However, the transition of this therapeutic agent to the interventional arena has been slow due to concerns among interventionists in using low molecular weight heparins without the availability of a "routine assay" to monitor the level of anticoagulation. Before the introduction of the ENOX test, it could take several hours to receive the results from the central laboratory, and waiting for these results prior to PCI is not feasible. The introduction of this new test now gives interventionists an important point-of-care tool to rapidly monitor enoxaparin levels in the catheterization catheterization

Threading of a flexible tube (catheter) through a channel in the body to inject drugs or a contrast medium, measure and record flow and pressures, inspect structures, take samples, diagnose disorders, or clear blockages.
 laboratory and should address the concerns of physicians when using the drug in many clinical situations." He added, "We have used the test in our clinical practice to collect data on over 75 patients and have found it very useful in assessing adequate anticoagulation prior to PCI in different groups of patients receiving subcutaneous enoxaparin. In those patients with subtherapeutic sub·ther·a·peu·tic  
adj.
Below the dosage levels used to treat diseases: subtherapeutic feeding of penicillin to livestock.



sub
 levels for PCI, the test also aids in evaluating the response to "booster" intravenous doses of enoxaparin (0.3 mg/kg i.v.)." We will be presenting our data at the Transcatheter Cardiovascular Therapeutics Meeting (TCT TCT The Capital Times (Madison, WI newspaper)
TCT Transcatheter Cardiovascular Therapeutics
TCT The Coroner's Toolkit
TCT Trans Canada Trail
TCT Tcl Core Team
TCT Tsukuba College of Technology (Japan) 
) in September."

"The test is now in use at a number of leading heart centers. We anticipate that these reference sites, in conjunction with published reports, will continue to both demonstrate that the test can make a contribution to improved patient safety and help us to expand the use of the technology," said, Michael Riddle, executive vice president of PharmaNetics. He added, "Data from our ELECT trial was presented last week at the International Society Thrombosis and Hemostasis hemostasis /he·mo·sta·sis/ (he?mo-sta´sis) (he-mos´tah-sis)
1. the arrest of bleeding by the physiological properties of vasoconstriction and coagulation or by surgical means.

2.
 Meeting, giving more exposure to the ENOX test ranges established for the safe performance of PCI and sheath removal. In addition, as the use of enoxaparin expands, there may be many occasions where a patient is transferred from another facility and the actual time of drug administration is unclear. We believe that, under these circumstances, there will be a growing need for the test to be used to confirm that the patient actually received the drug."

PharmaNetics, Inc. (NASDAQ/NM:PHAR), a leading biotech company, conceived the term "theranostics," defining an emerging new field of medicine that enables physicians to monitor the effect of antithrombotic agents in patients being treated for angina, myocardial infarction (heart attack), stroke, and pulmonary and arterial emboli emboli /em·bo·li/ (em´bo-li) plural of embolus.
Emboli
Plural of embolus. An embolus is something that blocks the blood flow in a blood vessel.
. The Company develops, manufactures and markets rapid turnaround diagnostics to assess blood clot formation and dissolution. PharmaNetics develops tests based on its proprietary, dry chemistry Thrombolytic thrombolytic /throm·bo·lyt·ic/ (throm?bo-lit´ik) dissolving or splitting up a thrombus, or an agent that so acts.

thrombolytic

1. dissolving or splitting up a thrombus.

2. an agent that dissolves or splits up a thrombus.
 Assessment System. Its principal target market is the management of powerful new drug compounds, some of which may have narrow therapeutic ranges, as well as monitoring routine anticoagulants Anticoagulants
Drugs that suppress, delay, or prevent blood clots. Anticoagulants are used to treat embolisms.

Mentioned in: Embolism, Heart Valve Replacement
.

This press release contains forward-looking statements regarding future events and the future performance of PharmaNetics that involve risks and uncertainties such as risks related to market acceptance, clinical trials and dependence on third-party distributors and collaborative partners that could cause actual results to differ materially from those projected in the forward-looking statements. Information concerning these and other of the factors that could cause results to differ materially from those in the forward-looking statements is contained in the Company's filings with the Securities and Exchange Commission, including Form 10-K, Form 10-Q and Form 8-K reports.
COPYRIGHT 2003 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2003, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jul 21, 2003
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