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Biotech / Medical : CVAS-an interesting california-based biotech company here -- Ignore unavailable to you. Want to Upgrade?

To: mopgcw who wrote (104)	11/5/2002 10:24:46 AM
From: tuck	Read Replies (1) \| Respond to of 126

>>SAN DIEGO, Nov. 5 /PRNewswire-FirstCall/ -- Corvas International, Inc. (Nasdaq: CVAS - News) today announced the commencement of a multi-center, Phase II clinical program to investigate the safety and efficacy of its proprietary anticoagulant, recombinant nematode anticoagulant protein c2 (rNAPc2), in patients with acute coronary syndromes (ACS) which include unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI). The objective of the clinical program referred to as ANTHEM/TIMI 32 (Anticoagulation with NAPc2 To Help Eliminate MACE (Major Adverse Cardiac Events)/TIMI 32) is to evaluate a safe and effective dose of rNAPc2 in moderate to high-risk patients with UA/NSTEMI. The program will be conducted in three parts, each of which will investigate rNAPc2 in combination with current anticoagulant and antiplatelet therapies using the low molecular weight heparin (LMWH) enoxaparin and aspirin, respectively. The use of the antiplatelet agents clopidogrel and platelet glycoprotein IIb/IIIa antagonists will also be included. The first part of the program will evaluate a safe dose range of rNAPc2 administered as an intravenous bolus injection using a double-blind, placebo-controlled dose escalation trial in 125 UA/NSTEMI patients who are likely to undergo cardiac catheterization leading to percutaneous coronary intervention (PCI) such as angioplasty or stent placement. The primary outcome measurement will be significant bleeding using contemporary criteria with secondary efficacy endpoints to include recurrent myocardial ischemia using continuous electrocardiographic monitoring over 7 days using portable Holter devices. The trial will be conducted in 15 clinical centers in the United States. The second and third parts of the program will focus on dose confirmation with the primary objectives of evaluating clinical efficacy and safety and will be double-blind, placebo-controlled studies including patients undergoing either early PCI or primary medical treatment. The ANTHEM/TIMI 32 Phase II clinical program may enroll up to 1,600 patients in 120 clinical centers in North America and Europe. Corvas will be working with the TIMI Study Group to conduct the Phase II program. The TIMI Study Group, led by Dr. Eugene Braunwald of Brigham and Women's Hospital and Harvard Medical School, is well known for conducting numerous clinical trials involving thousands of patients worldwide in cardiovascular disease and specifically ACS, including the evaluation of new anticoagulant strategies for UA/NSTEMI. At present there are nearly two million hospitalizations each year in the United States alone for ACS, a number that is rising as the population ages. The worldwide patient potential is expected to approach four million cases by the year 2007. Patients with ACS are currently treated with unfractionated heparin or low molecular weight heparins and aspirin. The antiplatelet agent clopidogrel has also been added in the recent treatment guidelines issued by the American Heart Association and American College of Cardiology. Platelet glycoprotein IIb/IIIa antagonists are also used in the treatment of UA/NSTEMI for patients primarily undergoing PCI. We believe the addition of rNAPc2 to this regime is an important step because a significant percentage of the treated ACS patients still experience death, myocardial infarction or recurrent chest pain within 30 days of their initial treatment. "The frequent recurrence of adverse clinical symptoms in UA/NSTEMI patients even after the best care available is thought to be caused by the ongoing activation of the blood coagulation process as reflected in continuing thrombin generation" said George P. Vlasuk, Ph.D., Chief Scientific Officer at Corvas. "rNAPc2 is considered to be a new approach in antithrombotic therapy based on its unique mechanism which blocks the earliest stages of the blood coagulation process thereby preventing further thrombin generation and thus, we believe it will be an important addition to the current treatment strategies for UA/NSTEMI patients" added Dr. Vlasuk. The novel anticoagulant rNAPc2 is a small protein that was originally isolated from blood-feeding hookworms and is currently manufactured as a recombinant protein for clinical use. The mechanism of rNAPc2 involves inhibition of the protease complex Factor VIIa/Tissue Factor, which is responsible for the initiation of the process leading to blood clot formation. Currently, rNAPc2 has been shown to be safe and well tolerated in close to 500 patients and volunteers studied to date, which includes a Phase II study in 293 patients undergoing total knee replacement where rNAPc2 was shown to safely reduce the incidence of deep vein thrombosis (DVT) by over 50% compared to a contemporary historical control with the low molecular weight heparin enoxaparin. A second Phase IIa study demonstrated that rNAPc2 could be safely added to standard therapy with unfractionated heparin, aspirin and clopidogrel in 150 patients undergoing elective PCI. This study also demonstrated that rNAPc2 suppresses the formation of thrombin for at least 36 hours following a single administration, compared to standard therapy alone, in which thrombin generation continued unabated.<< snip Cheers, Tuck