Cubist initiates dosing in Phase II blood loss therapy study

Conserv-1 is a Phase II trial evaluating the safety, efficacy and clinical outcomes of various doses of ecallantide for the reduction of blood loss volume during on-pump cardiothoracic surgery. The trial is expected to enroll more than 300 patients undergoing on-pump cardiothoracic surgery.

According to Cubist, ecallantide is a potent inhibitor of plasma kallikrein, and Conserv-1 will evaluate the effects of plasma kallikrein inhibition in patients on cardiopulmonary bypass during cardiothoracic surgery.

Santosh Vetticaden, chief medical officer of Cubist, said: “This trial represents an important event in the continued evaluation of ecallantide for the reduction of blood loss during on-pump cardiothoracic surgery, an area of significant unmet medical need and marked by the absence of any approved therapeutic options in the US. We anticipate that the results of this trial will provide meaningful insights into the optimal design of subsequent Phase III trials.”