Dose-defining Phase IIa trial of CXL-1020 initiated for treating patients with ADHF

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.

"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 database of safety information for CXL-1020. Further information on this trial can be found at www.clinicaltrials.gov at reference number NCT01096043.

Juan Aranda, M.D., Professor of Medicine, Director of Cardiac Transplantation at The University of Florida, Gainesville, who is an investigator in the Phase IIa study commented, "Based on Phase I/IIa clinical results with CXL-1020, we have reason to believe this cardiovascular drug will be an important new option in the treatment of patients with ADHF. This Phase IIa study will provide additional valuable insight into the potential benefits of CXL-1020 for these seriously ill patients."