COGENESYS TO INITIATE DEVELOPMENT OF CARDEVA FOR CHRONIC HEART FAILURE

CoGenesys announced that the FDA has completed its review of the company's investigational new drug application for Cardeva, a long-acting form of b-type natriuretic peptide (BNP), and that the company intends to begin clinical testing in the United States shortly, pending institutional review board approval.

Preclinical studies have demonstrated that Cardeva, a human serum albumin-BNP fusion protein, retains the pharmacological profile of BNP peptide but has a greatly extended half-life and long duration of action. The Phase I/II clinical trial of Cardeva will be a randomized, multicenter, double-blind, vehicle-controlled, ascending repeat-dose safety and tolerability trial in up to 80 stable subjects with Class II or III heart failure. Subjects will receive one or two doses of the drug.