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Results and Additional Analyses From Study Show That Corthera's Relaxin for Acute Heart Failure is the Strongest Predictor of Improved Longer-Term Outcomes Following Hospital Discharge When Compared to Other Variables
Date:6/1/2009

revention of heart failure worsening during hospitalization, shortening of in-hospital stay and improved longer-term outcomes following discharge when compared to placebo.

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 objective was proof-of-concept and dose and endpoint selection. Patients selected for the study presented to the hospital with dyspnea due to AHF and with normal or elevated blood pressure. In the Phase III RELAX-AHF study, the objective is to confirm safety and efficacy. The Pre-RELAX-AHF/RELAX-AHF study was designed and conducted in collaboration with Momentum Research, headed by Dr. Gad Cotter, a noted heart failure expert.

Patients in the Pre-RELAX-AHF study were randomly assigned to receive intravenous relaxin at doses of 10, 30, 100, or 250 mcg/kg/day or placebo for two days. The study indicated that the 30-mcg/kg dose of relaxin (relaxin-30) was the most effective. More patients, approximately 40%, reported moderate or marked improvements in dyspnea at six, 12 and 24 hours when treated with relaxin-30, as compared to 23% of patients assigned to placebo (p=0.04). Relief remained significantly greater at day 14. Researchers also noted trends with relaxin toward greater weight loss, less need for intravenous diuretics, and less worsening of heart failure in the hospital. When all of the doses of relaxin were compared with placebo, hospital stay was one to two days shorter. Relaxin had a good safety profile in the study.

Following 60 days, 3% of patients in the relaxin-30 group had been rehospitalized for heart failure and no patients died of cardiovascular causes, as compared to 17% in the placebo group (p=0.06), a greater than 80% reduction. After an average follow-up of four
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SOURCE Corthera Inc.
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