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

To: Miljenko Zuanic who wrote (76)	12/5/2001 9:17:01 AM
From: tuck	Read Replies (1) \| Respond to of 126

>>SAN DIEGO, Dec. 5 /PRNewswire/ -- Corvas International, Inc. (Nasdaq: CVAS - news) today announced that results from a Phase IIa clinical study show the Company's proprietary anticoagulant rNAPc2 appears to be safe and well tolerated when administered to patients prior to elective percutaneous transluminal coronary angioplasty (PTCA), a procedure often performed to treat people who suffer from coronary artery disease such as unstable angina. The data also show that, in contrast to standard therapy with heparin and aspirin alone, rNAPc2 effectively suppresses the formation of thrombin, a serine protease that is a key factor in causing the blood to clot. The complete data set from this Phase IIa trial will be presented on December 10, 2001, at the 43rd annual meeting of the American Society of Hematology in Orlando, Florida. The Company believes the data support its plan, subject to government regulation, to initiate a Phase II trial with rNAPc2 in unstable angina patients. There are approximately 700,000 people diagnosed each year with unstable angina in the United States; the annual worldwide incidence is estimated to be 1.7 million people. Unstable angina is characterized by severe chest pain, even at rest, that often results from the formation of a blood clot in one or more of the blood vessels of the heart. Even with the current standard therapy of aspirin and heparin, approximately 10-20% of unstable angina patients will experience a subsequent clinical event such as a heart attack or death within 30 days of hospital admission. ``We believe unstable angina presents a large market opportunity for rNAPc2 based on a strong medical need for more effective anticoagulant agents in this indication. By blocking the initiation of blood coagulation, rNAPc2 may result in clinical benefit over currently used anticoagulant drug strategies, which are less effective in preventing the formation of blood clots in this patient population,'' said George P. Vlasuk, Ph.D., Executive Vice President and Chief Scientific Officer. ``As many unstable angina patients undergo coronary intervention procedures, including PTCA and stent placement, we believe these Phase IIa results support our plan to initiate a double-blinded, placebo-controlled Phase II study of rNAPc2 in unstable angina patients in 2002.'' The Phase IIa trial was a randomized, placebo-controlled, double-blinded, dose-escalation study conducted in 156 patients with stable coronary artery disease undergoing elective PTCA. Each of the five treatment cohorts received either standard therapy with unfractionated heparin and aspirin (placebo) or standard therapy plus rNAPc2 administered as a single subcutaneous injection prior to the PTCA procedure at doses of 3.5, 5.0, 7.5 and 10.0 micrograms per kilogram (kg) body weight. 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 primary goal of the Phase IIa study was to determine the safety of rNAPc2 administered to patients undergoing elective PTCA by determining the femoral (groin) compression time (FCT) and the incidence of major and minor bleeding. The FCT is a measurement of the patient's primary coagulation response to a surgical incision used in the PTCA procedure. Prolongation of FCT indicates a greater effect of rNAPc2 on surgical bleeding, which is an important safety parameter in this patient population that will aid in the choice of a dose range for future clinical trials. Secondary objectives included assessment of the effect of rNAPc2 on the generation of thrombin as measured by plasma levels of prothrombin activation fragment 1+2 (F1+2). Results of the Phase IIa study indicated that administration of rNAPc2 across the complete range of doses that were used in this study appears to be safe in this patient population. The median FCT was similar in all rNAPc2 dose groups compared to placebo except for the highest dose group, which exhibited a statistically significant increase in median FCT. The incidence of major bleeding was low in rNAPc2 treated patients and was not dependent on the administered dose of rNAPc2. An increase in minor bleeding was observed in only the highest dose group. The biochemical F1+2 data obtained from blood tests demonstrated that a single subcutaneous injection of rNAPc2 produced a prolonged, statistically significant and sustained suppression of thrombin generation for the duration of the 36-hour observation period. Furthermore, while the generation of thrombin decreased from pre-treatment levels in all treatment groups, there was a significant rebound above baseline levels only in the placebo group. ``Several lines of evidence presented in the scientific literature have shown a correlation between the formation of thrombin and a higher incidence of thrombotic complications in unstable angina patients,'' said Dr. Vlasuk. ``Our Phase IIa data show that treatment with rNAPc2 in combination with standard therapy resulted in a prolonged suppression of thrombin formation versus standard therapy alone. We believe this result suggests that rNAPc2 may prove to be effective in suppressing clot formation in patients with unstable angina and that rNAPc2 warrants clinical study in that patient population.'' The rNAPc2 protein was originally derived from 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). Including this 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 for the prevention of deep vein thrombosis. The Phase II results demonstrated that rNAPc2 appears to reduce the risk of developing deep vein thrombosis and related complications, by over 50% compared to the current standard therapy for patients undergoing total knee replacement surgery without compromising safety.<< snip Cheers, Tuck