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Back To Vidyya Link Between Harmful Complement Activation And Adverse Clinical Outcomes In Heart Failure Patients Published

Study Appears In The April Issue Of The American Heart Journal

Alexion Pharmaceuticals, Inc. today announced the publication of results from a collaborative project with scientists from Yale University School of Medicine in the American Heart Journal. The study describes that elevations in harmful complement activation in patients with congestive heart failure (CHF) are associated with worse clinical symptoms and a reduced rate of event-free survival over a period of six months. Alexion's C5 Complement Inhibitor humanized monoclonal antibody 5G1.1 specifically blocks the production of harmful complement components and may be useful in treatment of this patient population.

"The current study suggests that pathologic complement activation may contribute to worsening clinical status in patients with severe heart failure," stated John F. Setaro, M.D., Associate Professor of Medicine and Director of Cardiovascular Disease Prevention at Yale, and co-author of the study. "While current therapies for heart failure patients are directed at attempting to improve cardiac performance via improving control of blood pressure and fluid status, an increasing number of recent observations have suggested that chronic inflammation may contribute to the underlying clinical illness in patients with severe heart failure. These results raise the exciting possibility that control of inflammation via inhibition of the complement cascade may provide a new avenue of treatment for future focus in heart failure patients."

In the study, conducted in 36 patients with severe congestive heart failure, published by Dr. Setaro and his colleagues at Yale and Alexion, the clinical endpoint was the composite six-month incidence of death, admission to the hospital with worsening heart failure, or requirement for urgent heart transplantation. Additionally, complement levels were measured at initial presentation. In patients with higher complement levels, the six-month event-free survival rate of 44% was significantly (P<.05) lower than the six-month event-free survival rate of 83% in patients with lower complement levels. Additionally, in patients with higher complement levels the incidence of the most severe heart failure, as evidenced by NYHA Class IV symptoms in 67% of patients, was significantly (P<.04) greater than the 33% incidence of such severe heart failure in patients with lower complement levels.

"This collaborative discovery by Alexion and Yale scientists strengthens the likelihood that complement activation impacts upon the clinical course of heart failure," said Leonard Bell, M.D., President and Chief Executive Officer of Alexion. "These investigative clinical studies are an important part of our ongoing program to identify additional clinical areas where our novel anti-inflammatory drugs may provide significant therapeutic benefit to patients with severe and unmet medical needs."

According to the 2000 Heart and Stroke Statistical Update from the American Heart Association (AHA), there are approximately 4,600,000 Americans with CHF and the estimated 5-year survival rate for these patients is approximately 50%. The AHA further estimates that there are approximately one million hospital discharges annually for CHF and that approximately $22.5 billion are spent annually on the direct and indirect costs of treatment of CHF in the U.S.

Alexion's C5 Complement Inhibitors are designed to selectively block the production of inflammation-causing proteins in a process of the human immune system known as the complement cascade. Selective suppression of this immune response may provide a significant therapeutic advantage relative to existing therapies. Because of the generally beneficial effects of the components of the complement cascade prior to the fifth component (C5) and the greater inflammatory disease-promoting effects of the cleavage products of C5, the Company has identified C5 as a potentially effective anti-inflammatory drug target.


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Editor: Susan K. Boyer, RN
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