Ecallantide for the prevention of bleeding in cardio-thoracic surgery:
Unmet Medical Need:
Cubist estimates that more than 650,000 patients annually undergo on-pump cardiothoracic surgery (CTS), which includes coronary artery bypass grafting (CABG) and heart valve replacement or repair procedures, in order to correct myocardial ischemia or diseased valves that cannot be treated with less invasive procedures. When a patient's blood comes into contact with the artificial surface of the cardiopulmonary bypass (CPB) machine and tubing, serious complications can result, including the systemic inflammatory response syndrome (SIRS), a whole body inflammatory state that compromises heart and lung function in already fragile patients. Blood loss also occurs as a result of this major surgery and can be exacerbated by SIRS. Aprotinin, an agent previously approved and marketed for the reduction of blood loss during on-pump surgery, was withdrawn from the market in 2008, creating a large unmet medical need.
Key Scientific/Clinical Data:
In a proof of concept study of ecallantide for the reduction of blood loss in CTS conducted by Dyax Corp, from whom Cubist obtained the rights to develop and commercialize ecallantide in North America and Europe for surgical indications in April, 2008, the magnitude of the treatment benefit, approximately a 50% reduction in transfusion volume compared with placebo, was consistent with the effects of aprotinin. In clinical trials to date, ecallantide has been well tolerated in healthy subjects and in patients undergoing CTS.
Cubist’s goal is to bring ecallantide rapidly to market as a therapy to reduce bleeding in CTS. To achieve this goal, Cubist plans to advance ecallantide as quickly as possible to a Phase 3 randomized controlled clinical trial. Cubist currently is developing the protocol for a definitive dose ranging study that the company expects will represent the completion of Phase 2 development.
Upcoming Milestones: Cubist plans to initiate a Phase 2 dose-ranging study year-end 2008.
Monday, September 8, 2008
Posted by firstname.lastname@example.org (hemostat guy) at 5:32 PM
Wyeth Pharmaceuticals, a division of Wyeth, announced that product shipments have begun for XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free, a new recombinant factor VIII product for both the control and prevention of bleeding episodes and surgical prophylaxis in patients with hemophilia A, a rare, inherited blood-clotting disorder.Shipments of the Company's current recombinant factor VIII product, ReFacto Antihemophilic Factor (Recombinant) in the United States will be discontinued as of May 31, 2009.