Cubist Initiates Phase 2 Trials in Europe for Therapy to Reduce Blood Loss during Surgery in High Risk Patients
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Cubist Pharmaceuticals, Inc. has announced that it has begun dosing in the CONSERV™-2 clinical trial with ecallantide. CONSERV-2, being conducted in Europe, is a Phase 2 trial that will investigate ecallantide’s effect on surgical blood loss volume in cardiac surgery patients who are on cardiopulmonary bypass and are at a high risk of bleeding. The trial is expected to enroll 300 subjects.
Ecallantide is a potent inhibitor of plasma kallikrein, and CONSERV-2 will evaluate the effects of plasma kallikrein inhibition in the trial population. Surgical environments, such as those involving the trial population, are associated with the activation of plasma kallikrein and subsequent activation of coagulation, fibrinolytic, and inflammatory cascades, which likely contribute to blood loss and blood transfusion requirements in the perioperative setting.
“The dosing of patients in the CONSERV-2 trial represents another important milestone in the continued evaluation of ecallantide for the reduction of blood loss during on-pump cardiac surgery, an area of significant unmet medical need. We remain on track for a mid-2010 end-of-phase 2 meeting with the FDA, and we anticipate that the results of this trial and the ongoing CONSERV-1 trial will provide meaningful insights into the optimal design of subsequent Phase 3 trials,” said Santosh Vetticaden, PhD, MD, Senior Vice President, Clinical Development and Chief Medical Officer.
“This represents another important milestone for our growing pipeline of novel acute care therapeutics” said Steve Gilman, PhD, Chief Scientific Officer and Senior Vice President, Discovery and Nonclinical Development.
In April 2008, Cubist announced an exclusive North American and European license and collaboration agreement with Dyax Corp. for the development and commercialization of the intravenous formulation of ecallantide for surgical indications. The first indication being sought by Cubist for ecallantide is the reduction of blood loss during on-pump cardiac surgery.
Ecallantide is a potent inhibitor of plasma kallikrein, and CONSERV-2 will evaluate the effects of plasma kallikrein inhibition in the trial population. Surgical environments, such as those involving the trial population, are associated with the activation of plasma kallikrein and subsequent activation of coagulation, fibrinolytic, and inflammatory cascades, which likely contribute to blood loss and blood transfusion requirements in the perioperative setting.
“The dosing of patients in the CONSERV-2 trial represents another important milestone in the continued evaluation of ecallantide for the reduction of blood loss during on-pump cardiac surgery, an area of significant unmet medical need. We remain on track for a mid-2010 end-of-phase 2 meeting with the FDA, and we anticipate that the results of this trial and the ongoing CONSERV-1 trial will provide meaningful insights into the optimal design of subsequent Phase 3 trials,” said Santosh Vetticaden, PhD, MD, Senior Vice President, Clinical Development and Chief Medical Officer.
“This represents another important milestone for our growing pipeline of novel acute care therapeutics” said Steve Gilman, PhD, Chief Scientific Officer and Senior Vice President, Discovery and Nonclinical Development.
In April 2008, Cubist announced an exclusive North American and European license and collaboration agreement with Dyax Corp. for the development and commercialization of the intravenous formulation of ecallantide for surgical indications. The first indication being sought by Cubist for ecallantide is the reduction of blood loss during on-pump cardiac surgery.
