|
FOR IMMEDIATE RELEASE
December 6, 2000
PHARMANETICS ANNOUNCES NEW CLINICAL STUDY WITH PROMINENT INVESTIGATION TEAM
RALEIGH, N.C. (December 6, 2000) - PharmaNetics, Inc. (NASDAQ NM: PHAR) ), a leading company specializing in theranostic management of various therapeutics affecting coagulation, today announced plans to conduct a multi-center clinical study to be coordinated by an investigative team that has been at the forefront of clinical research in acute coronary syndromes (ACS) over the past two decades. Funded by PharmaNetics, the investigation will be a sub-study of the ENTIRE (TIMI 23) trial. The ENTIRE – TIMI 23 trial is co-chaired by Dr. Elliott Antman, Associate Professor of Medicine at Harvard Medical School and a member of the TIMI Study Group, and Prof. F. Van de Werf, Professor of Medicine, Catholic University of Leuvan, Belgium. ENTIRE – TIMI 23 is an Aventis Pharmaceuticals-sponsored study designed to evaluate novel combinations of fibrinolytic (TNK-tPA), antiplatelet (Reopro), and antithrombin (Enoxaparin) agents for management of ST elevation ACS. If successful, the combination of these agents for reperfusion therapy could soon expand the clinician's options for managing these patients.
The study will focus on the Lysis Onset Time (LOT) test and will investigate the predictive value of the LOT test in patients receiving thrombolytic therapy and determine the utility of the test for monitoring the patient's response to the drug administered to dissolve the blood clot and restore blood flow.
The study will be coordinated by the Thrombolysis In Myocardial Infarction (TIMI) Study Group. The TIMI Study Group, organized in 1984 and chaired by Dr. Eugene Braunwald of Brigham and Women's Hospital in Boston, Massachusetts, is committed to advancing the knowledge and care of patients suffering from ACS. Dr. Antman will be the principal investigator for the sub-study, which is expected to include 10-15 major medical centers in the United States and Europe.
"We are committed to continuing to improve our non-invasive tools for monitoring the success of thrombolytic therapy. The ability to predict the success or failure of treatment early after initiation could allow physicians the opportunity to respond quickly," said Dr. Braunwald. "We are enthusiastic about the opportunity to explore the potential of the LOT test as a clinical and research tool," continued Dr. Braunwald.
Commenting on the announcement, Mike Riddle, Executive Vice President of PharmaNetics, said, "As a result of the encouragement we have received from the medical community and their interest in our theranostic strategy, we have decided to fund this study and are grateful to Aventis for allowing us access to ENTIRE. We believe that the use of the test in combination with the electrocardiogram will provide physicians with a valuable management tool and satisfy an unmet medical need. We are very fortunate to have the support of the TIMI Group in this endeavor, and we are pleased that they are taking the lead role in investigating the test's potential to facilitate better patient care."
Current non-invasive indicators of effective thrombolysis such as electrocardiogram (ECG) provide valuable information to clinicians monitoring the success of pharmacological reperfusion therapy, but they are relatively poor indicators of failed treatment. As a direct measure of the effect of the drug, the LOT may enable very early identification of patients who are non-responsive to thrombolytic therapy and who should be considered for modified therapy, including individual dose adjustments, or early angiography and rescue intervention. It is estimated that there are over 400,000 cases every year in the United States of ACS with ST-segment elevation eligible for thrombolytic therapy. However, despite the therapy's proven benefits, some patients, particularly the elderly, are denied treatment because of the higher risk for complications such as intracerebral hemorrhage. The clinical investigators believe that the test would allow each patient to be monitored during treatment and could be useful in optimizing the dosing to reduce the serious adverse events that can cause death in some patients. This could improve the safety and efficacy of the drug and increase the appropriate use of the therapy.
PharmaNetics, Inc., a leading biotech company, conceived the term "theranostics," defining an emerging new field of medicine that enables physicians to therapeutically manage coagulation parameters of their patients in the treatment of angina, myocardial infarction (heart attack), stroke, and pulmonary and arterial emboli. The Company's proprietary diagnostic platform generates rapid feedback on blood clot formulation and dissolution. The Company's technology platform is the primary driver of existing collaborations with a number of major pharmaceutical companies, including Aventis Pharmaceuticals, AstraZeneca and Knoll BASF, to develop theranostic tests for specific compounds and disease indications being developed by these corporations. If those drugs receive FDA approval, PharmaNetics' tests could become an essential component of the treatment modality of these drugs affecting coagulation.
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 form 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.
|
|
|
