FDAnews
www.fdanews.com/articles/78819-ularitide-study-highlighted-at-european-society-of-cardiology-congress

ULARITIDE STUDY HIGHLIGHTED AT EUROPEAN SOCIETY OF CARDIOLOGY CONGRESS

September 6, 2005

Protein Design Labs has announced positive data from a Phase II clinical study of ularitide -- the synthetic version of a natriuretic peptide produced in the kidney known as urodilatin -- as a potential treatment for patients with acute decompensated heart failure. The data from the trial were presented at the annual European Society of Cardiology Congress, which took place September 3-7 in Stockholm, Sweden.

The SIRIUS II trial was a randomized, double-blind, placebo-controlled clinical trial conducted at 19 centers across Europe. A total of 221 patients were randomized equally to receive ularitide 7.5-, 15-, or 30-mg/kg/min given intravenously as a 24-hour infusion, or placebo. The two primary endpoints in the study were change in dyspnea (shortness of breath) score and change in pulmonary capillary wedge pressure, a measurement of lung vessel pressure, at six hours.