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PharmaNetics Completes Enrollment of 600-Patient Elect Trial; ENOX Results To Be Presented At American Heart Association Meeting.


Business Editors & Health/Medical Writers

RALEIGH, N.C.--(BUSINESS WIRE)--Sept. 12, 2002

PharmaNetics, Inc. (Nasdaq/NM: PHAR), a leader in theranostics specializing in the management of therapeutics affecting coagulation coagulation (kōăg'ylā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or , today announced that it has completed the target enrollment of 600 patients in its ELECT (EvaLuating Enoxaparin Clotting Times) study.

ELECT is a joint collaboration between PharmaNetics and leading interventional cardiologists at The Cleveland Clinic and Duke Clinical Research Institute. Principle investigators, David J. Moliterno, M.D., The Cleveland Clinic, and James E. Tcheng, M.D., Duke Clinical Research Institute, coordinated the multi-center study at 17 sites across the U.S. The Company expects to announce results at the American Heart Association American Heart Association (AHA),
n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities.
 Meeting in November 2002. ELECT was conducted in patients undergoing 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).
 or "angioplasty") procedures. The study evaluated the use of the Company's lead product, the ENOX(TM) test, in conjunction with enoxaparin in facilitating treatment of acute coronary syndrome acute coronary syndrome
n.
A sudden, severe coronary event that mimics a heart attack, such as unstable angina.


acute coronary syndrome 
 patients who may transition to PCI.

ELECT is an open-label, observational trial assessing the Rapidpoint ENOX point-of-care device in approximately 600 PCI patients receiving either subcutaneous or intravenous enoxaparin as the antithrombin therapy during PCI, with or without adjunctive platelet GP IIb/IIIa inhibitor therapy. All PCI procedures were performed according to each institution's standards. As such, individual physician's decisions regarding use and selection of stents, GP IIb/IIIa inhibitors, and vascular access vascular access Clinical medicine The ability to enter the vascular system; the ease with which the vascular system can be entered for administering therapy or obtaining blood for testing  closure devices represent the most contemporary practice.

The primary objective of the study is to assess the predictive value of the ENOX test to measure the whole blood anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting).  effect of the low-molecular-weight heparin enoxaparin relative to ischemic Ischemic
An inadequate supply of blood to a part of the body, caused by partial or total blockage of an artery.

Mentioned in: Antiangiogenic Therapy, Subarachnoid Hemorrhage, Ventricular Fibrillation


ischemic
 and hemorrhagic Hemorrhagic
A condition resulting in massive, difficult-to-control bleeding.

Mentioned in: Hantavirus Infections


hemorrhagic

pertaining to or characterized by hemorrhage.
 outcomes associated with PCI. With this information, optimal therapeutic reference ranges for the performance of PCI with stent implantation and for post-PCI vascular sheath removal may be determined.

ENOX is a one-step test, performed on the Rapidpoint Coag analyzer. All of the components necessary to perform the assay, with the exception of the patient sample, are included in the reaction chamber of the test card. The test provides information on the patient's whole blood response to enoxaparin by measurement of the clotting time using a factor Xa activated clotting method. 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 operating rooms, the activated clotting time (ACT) is commonly used to monitor unfractionated heparin anticoagulation levels. Previous clinical trials have shown enoxaparin to be superior to unfractionated heparin in the treatment of patients with acute coronary syndromes when administered concomitantly with aspirin. Evolving data also demonstrate that patients who transition to PCI earlier in their hospital course have better short-term and intermediate-term outcomes when treated with enoxaparin versus standard heparin. Until now, rapid, point-of-care monitoring systems have not been available for enoxaparin. While central laboratory assessment of enoxaparin using a factor Xa test is available, this technology is generally limited to specialized coagulation laboratories and is time intensive, making it impractical for quick decision-making.

Enoxaparin is approved for more clinical indications than any other low-molecular-weight heparin. The product is known as Lovenox(R) in the United States, Canada and France, and generally known as Clexane(R) in the rest of the world.

PharmaNetics, Inc., 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 for its principal target market of managing powerful new drug compounds, some of which may have narrow therapeutic ranges, as well as for monitoring routine anticoagulants Anticoagulants
Drugs that suppress, delay, or prevent blood clots. Anticoagulants are used to treat embolisms.

Mentioned in: Embolism, Heart Valve Replacement
. For more information about the Company and the ENOX Test, please visit PharmaNetics' website at: www.pharmanetics.com.

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 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.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Sep 12, 2002
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