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Interim Analysis of Top-Line Data From Phase II/III Study Shows Favorable Efficacy & Safety for Corthera's Relaxin in Acute Heart Failure
Date:11/10/2008

SAN MATEO‚ Calif.‚ Nov. 10 /PRNewswire/ -- Corthera Inc. today announced that an interim analysis of top-line data from Pre-RELAX-AHF, the Phase II portion of a Phase II/III multicenter, randomized, double-blind, international study, showed favorable efficacy and safety for relaxin, the company's investigational drug for treatment of acute heart failure.

The interim Phase II results were presented by John R. Teerlink, M.D., Professor of Medicine, University of California San Francisco, in a satellite symposium at the American Heart Association's (AHA) Scientific Sessions 2008 in New Orleans. The data from the first 209 patients enrolled in the trial demonstrated beneficial trends in acute heart failure (AHF) signs, symptoms and outcomes with no evidence of renal toxicity. Relaxin appeared safe and well-tolerated over a wide dose range.

"The data indicate that relaxin is a very promising treatment for AHF," said Teerlink, co-principal investigator of the study. "Compared to placebo, relaxin's effect on the important endpoint of relieving dyspnea, breathlessness, was apparent within 6 hours after start of treatment. These initial effects lasted up to 14 days after treatment, something not previously seen with other therapies for AHF. Relaxin's safety profile in the study's patient population was benign during and following drug treatment, while blood pressure effects were predictable and manageable. There were also encouraging trends in other in-hospital endpoints, including weight-loss due to diuresis, incidence of worsening heart failure and length of hospital stay. The consistency of these improvements across multiple measures of outcomes is very encouraging."

Corthera's Pre-RELAX-AHF/RELAX-AHF study is a Phase II/III, multicenter, randomized, double-blind, placebo-controlled, parallel-group, international trial designed to evaluate the efficacy and safety of relaxin for the treatment of AHF. In the Phase II Pre-RELAX-AHF study, the obje
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SOURCE Corthera Inc.
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