RNAPc2 in ACS, Results of ANTHEM-TIMI 32. June 22, 2007

Novel Anti-thrombin Data Published
June 22, 2007 By Sabina A. Murphy, M.P.H. [mailto:smurphy@perfuse.org]

Boston MA, USA: The ANTHEM–TIMI-32 study of the novel anti-thrombin, recombinant NAPc2, an inhibitor of the tissue factor/factor VIIa complex, showed promise in reducing ischemia with higher doses of the drug compared with placebo, but did not eliminate the need for heparin in the setting of PCI for non-ST elevation ACS. The trial was published this week in the Journal of the American College of Cardiology.

The study was a randomized trial of rNAPc2 compared with placebo in 255 patients with non-ST elevation ACS undergoing an early invasive strategy with angiography. In the second phase of the trial, all patients received high-dose rNAPc2 with or without UFH to determine if thrombin inhibition with rNAPc2 would be sufficient to eliminate the need for heparin.

There was no excess bleeding with rNAPc2 until the highest dose group, which had all 4 of the major bleeds in the trial. The primary endpoint of major or minor bleeding occurred in 3.7% of the rNAPc2 group and 2.5% of the placebo group (p=NS). Ischemia on continuous ECG monitoring was improved in the higher dose rNAPc2 groups compared with placebo.

In the open-label portion of the study in which all patients received rNAPc2 and patients were randomized to no heparin or half-dose UFH, thrombotic bailout occurred more often in the no heparin group (19% vs. 0%; p = 0.051). Intracoronary thrombus formed during PCI in 4 of the 5 cases of thrombotic bailout.

The trial was funded by Nuvelo, Inc.