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Cardioxyl Pharmaceuticals Initiates Dose-Defining Phase IIa Study of Its Lead Candidate, CXL-1020, in Heart Failure Patients
Date:8/26/2010

CHAPEL HILL, N.C., Aug. 26 /PRNewswire/ -- Cardioxyl Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing therapeutic agents for the treatment of cardiovascular disease, today announced that it has initiated a dose-defining Phase IIa trial of its lead drug candidate, CXL-1020, for the treatment of patients with acute decompensated heart failure (ADHF). ADHF is the leading diagnosis for patients at the time of discharge from U.S. hospitals and the most common cause of hospitalization for patients over 65 years of age.(i)

"Following the significant clinical results from our recently completed Phase I/IIa dose escalation study demonstrating CXL-1020's attractive hemodynamic and safety profile, we are excited to continue to evaluate this important new therapy for patients with ADHF," said Chris Kroeger, M.D., Cardioxyl Pharmaceuticals President and Chief Executive Officer. "We believe that CXL-1020 is the only cardiovascular product in development that provides the ideal balance of blood vessel dilation combined with direct enhancement of cardiac diastolic and systolic function."

Cardioxyl's placebo-controlled, multi-center Phase IIa study is designed to further define a suitable clinical dosage for CXL-1020, and is being conducted at up to 20 U.S. and international clinical sites. This three-cohort study will enroll 54 to 66 cardiac patients with decompensated heart failure.  Hemodynamic parameters are being evaluated during intravenous infusion of CXL-1020 at several dose levels. Investigators will assess hemodynamics utilizing invasive and non-invasive techniques including both echocardiography and direct Swan-Ganz catheter-based measures of heart pressures and function.  The primary efficacy endpoints for this study include an evaluation of dose-related hemodynamic effects. The study will also expand the d
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SOURCE Cardioxyl Pharmaceuticals, Inc.
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