Ecallantide: Development discontinued
Cubist discontinued development of ecallantide after reviewing top-line data from the CONSERV-1 and CONSERV-2 Phase II trials. In the double-blind, U.S. CONSERV-1 trial in 249 patients undergoing coronary artery bypass graft (CABG) surgery while on cardiopulmonary bypass (CPB), approximate doses of 5, 25 and 75 mg IV ecallantide showed no improvement in blood loss as measured by the need for transfusion of blood and blood products vs. placebo. The double-blind, European CONSERV-2 trial evaluated IV ecallantide in 218 patients undergoing cardiac surgery while on CPB for procedures including repeat sternotomy, CABG plus valve replacement and more than 1 valve replacement. Data from CONSERV-2 showed that an approximate dose of 75 mg IV ecallantide showed no treatment benefit and led to a significantly higher rate of mortality compared to the tranexamic acid control arm. ...