Corvas Completes Phase IIa Angioplasty Trial With rNAPc2 Anticoagulant
SAN DIEGO, June 6 /PRNewswire/ -- Corvas International, Inc. (Nasdaq: CVAS - news) today announced that it has completed the planned enrollment of the multi-center, Phase IIa safety trial of the proprietary injectable anticoagulant, recombinant Nematode Anticoagulant Protein c2 or rNAPc2, in patients undergoing elective percutaneous transluminal coronary angioplasty (PTCA). Following un-blinding and analysis of the data set, the final results from this trial will be available later this year.
The primary goal of this study was to determine the safety of rNAPc2 administered to patients undergoing elective PTCA by determining the groin compression time and the incidence of major and minor bleeding. The groin compression time is a measurement of the patient's coagulation response to a surgical incision used in the PTCA procedure. The more prolonged the groin compression time from normal, the greater anticoagulant effect of rNAPc2. Secondary objectives included the measurement of selected biochemical markers related to the activity of the blood coagulation process and platelet activation. The safety data obtained from this Phase IIa trial will be used in the design of future clinical studies evaluating rNAPc2 in patients with acute coronary syndromes, such as unstable angina, since many of these patients undergo coronary intervention procedures including PTCA and stent placement.
Including the recently completed Phase IIa PTCA trial, rNAPc2 has been evaluated in approximately 500 patients and healthy volunteers in several Phase I studies as well as a Phase II trial which demonstrated the safety and efficacy of rNAPc2 in the prevention of deep vein thrombosis (DVT) following unilateral knee replacement. Based on these Phase II results, Corvas intends to initiate two Phase III clinical trials later this year which will compare rNAPc2 to low molecular weight heparin for the prevention of DVT in patients undergoing major orthopedic surgery.
The Phase IIa PTCA trial was a randomized, placebo-controlled, double-blinded, dose-escalation study. Each of the five treatment cohorts consisted of at least 30 patients that received either standard therapy with unfractionated heparin and aspirin or standard therapy plus rNAPc2 administered as a single subcutaneous injection prior to the PTCA procedure. Many of the patients also received the anti-platelet agent clopidogrel (Plavix®) and to a lesser extent glycoprotein IIb/IIIa platelet receptor antagonists. Approximately half of the patients underwent coronary stent placement. The study was conducted exclusively at clinical centers in The Netherlands.
``The safety data from this trial is an important step in the evaluation of rNAPc2 as an alternative anticoagulant strategy in patients suffering from acute coronary syndromes. This trial adds to our overall clinical experience with rNAPc2 as we continue to broaden the range of clinical indications for this novel anticoagulant,'' stated Dr. George P. Vlasuk, Chief Scientific Officer at Corvas.
The treatment of acute coronary syndromes such as unstable angina and non-Q-wave myocardial infarction represents a significant potential expansion of the market opportunity for rNAPc2. In both the United States and Europe, acute coronary syndrome accounts for more than 1 million hospital admissions annually. Despite current treatments, 10-20% of patients suffering from acute coronary syndrome experience additional severe events such as death or myocardial infarction within six months.
The rNAPc2 protein was originally derived in blood-feeding hookworms, and is currently manufactured as a recombinant protein for clinical use. The anticoagulant effect of rNAPc2 results from its ability to block the factor VIIa/tissue factor protease complex which initiates the first step in the cascade of biochemical events resulting in the formation of blood clots (thrombosis). |
