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Biogen Idec, Cardiokine Begin Phase III CHF Trial

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Biogen Idec and Cardiokine, Inc. initiated a Phase III study of lixivaptan for congestive heart failure patients who suffer from hyponatremia, which is an electrolyte disturbance marked by low sodium levels in the blood. The trial will compare treatment with lixivaptan to placebo in approximately 650 patients in the U.S. and Europe.
   
Lixivaptan is an oral vasopressin V2 receptor antagonist that works by causing a decrease in renal water reabsorption (an increase in urine volume) and a decrease in urine osmolality. Previous studies showed patients treated with lixivaptan had improved serum sodium concentrations, decreases in body weight, and increases in urine volume. The safety profile supports continued development.
   
THE BALANCE (Treatment of HyponatrEmia BAsed on LixivAptan in NYHA Class III/IV Cardiac Patient Evaluation) study is a multi-center, randomized, placebo controlled, double-blind study of lixivaptan. The primary endpoint of the study is to evaluate the safety and effectiveness of lixivaptan, when compared to placebo, in increasing serum sodium from baseline in heart failure patients with hyponatremia. Hyponatremia is common in patients who have been hospitalized with worsening heart failure.
   
Under the terms of the collaboration, the two companies plan to jointly develop the drug. Biogen Idec will be responsible for global commercialization and Cardiokine will have an option for co-promotion in the U.S.

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