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This multi-center, double-blind, placebo-controlled, ascending dose-escalation study, known as ANTHEM (Anticoagulation with NAPc2 To Help Eliminate Mace)/TIMI 32, was conducted with the TIMI Study Group led by Eugene Braunwald, M.
NASDAQ:CVAS) presented results of preclinical studies on NAPc2 Wednesday at the 69th Scientific Sessions of the American Heart Association in New Orleans.
After licensing the molecule from Dendreon Corporation in February 2004, Nuvelo took steps to reinitiate the study also referred to as ANTHEM (Anticoagulation with NAPc2 To Help Eliminate Mace)/TIMI 32.
for the manufacture of clinical supplies of NAPc2 in preparation for human trials, expected to begin in early 1997.
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.
Based on these findings, and on a significant body of unpublished data, Corvas has selected a lead candidate, NAPc2, for development as a potential antithrombotic drug for the treatment of major acute cardiovascular diseases such as deep vein thrombosis, pulmonary embolism, unstable angina and heart attack.
One of these anticoagulant proteins, NAPc2, was found to block an early step in the complex cascade of biochemical events that results in the formation of blood clots (thrombosis).
In addition, there is the risk that the Phase II clinical trials or any future trials undertaken will not be successful or that NIF, NAPc2, PAI antagonists, uPA inhibitors or other drug candidates in its pipeline may never become marketable products and that the Company's strategic alliances with Pfizer and Schering-Plough will not be successful.
Operating expenses increased primarily due to clinical development expenses associated with the NAPc2 and NAP5 programs.
While today's news is disappointing, Corvas is pleased to continue our strong relationship with Schering-Plough with two other programs and we remain excited about our other drugs in the clinic including our proprietary anti-coagulant NAPc2 scheduled to enter Phase II later this year and NIF (neutrophil inhibitory factor) being developed by Pfizer Inc.
on its proprietary parenteral anticoagulant, NAPc2.
Its proprietary NAPc2 anticoagulant drug candidate is scheduled to enter Phase II clinical trials in 1998.
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