Cardioxyl Pharmaceuticals' Data Presented at American College of Cardiology (ACC) Annual Scientific Sessions
Data on Nitroxyl Donors and CXL-1020 Presented at Symposium on Emerging Therapies in Acute Decompensated Heart Failure (ADHF)
Atlanta, GA and Chapel Hill, NC– April 1, 2010 – Cardioxyl Pharmaceuticals, Inc., a clinical stage pharmaceutical company developing therapeutic agents for the treatment of acute decompensated heart failure (ADHF) and other cardiovascular diseases, announced the presentation on Monday, March 15th of a comprehensive review of the pharmacological effects of nitroxyl (HNO) in the treatment of ADHF. The presentation was part of the ACC’s “Emerging Therapies for the Treatment of Acute Decompensated Heart Failure Symposium.”
Dr. William Abraham, Professor of Internal Medicine and Director of the Division of Cardiovascular Medicine at the Ohio State University Medical Center delivered a state-of-the-art update on the use of nitroxyl donors in the treatment of ADHF in a session entitled, “Nitroxyl Donors: A New Generation of Inodilators.” Dr. Abraham presented preclinical data outlining the cellular mechanism of action of nitroxyl donors, as well as their effects in animal models of heart failure. The presentation highlighted the potential of nitroxyl donors, and specifically CXL-1020, as novel agents which alter cardiac contraction and relaxation by unique pharmacological mechanisms. Dr. Abraham’s presentation outlined how nitroxyl donors are both mechanistically and physiologically distinct from all previous inodilator therapies utilized in the treatment of this syndrome, which currently accounts for more hospitalizations in the USA for patients over age 65 years than any other diagnosis.
Chris Kroeger, MD, President and Chief Executive Officer of Cardioxyl Pharmaceuticals, commented, “These data, combined with the results of prior studies, confirmed the effects of CXL-1020 in pre-clinical models of heart failure and provided a firm foundation to support the advancement of CXL-1020 into the clinic. Cardioxyl is currently conducting a Phase I/IIa dose-ranging study in patients with chronic stable heart failure to evaluate the safety and tolerability of CXL-1020, as well as the effects of this agent on non-invasive hemodynamic parameters and pharmacokinetics.”
“We are gratified that the scientific and medical community continues to express significant interest in the potential of CXL-1020, and nitroxyl in general, as a potentially useful therapy for the treatment of ADHF,” commented Doug Cowart, PharmD., EVP of Clinical Development and Regulatory Affairs of Cardioxyl Pharmaceuticals. Dr. Abraham added, “The ongoing and planned clinical studies will continue to clarify the role of this promising new class of therapeutics in acute decompensated heart failure.”
During the presentation at the ACC, Dr. Abraham highlighted previous research demonstrating that nitroxyl has been shown to have positive cardiovascular effects that may benefit patients with ADHF. CXL-1020, a proprietary nitroxyl donor, is Cardioxyl’s lead compound for the intravenous treatment of acute decompensated heart failure (ADHF). CXL-1020 is a pro-drug that breaks down under physiological conditions and liberates nitroxyl (HNO). Cardioxyl is now completing a Phase I/IIa safety and dose-escalation study of CXL-1020 in stable chronic heart failure subjects and will soon initiate a new study in patients who are hospitalized with severe heart failure. Based on all pre-clinical studies to date, CXL-1020 is anticipated to improve the symptoms, hemodynamics and clinical status of patients with ADHF.
About Acute Decompensated Heart Failure (ADHF) and Current Treatment Options
ADHF is the leading diagnosis at the time of discharge from U.S. hospitals and the most common cause of hospitalization for patients over 65 years of age. Well over $37 billion was spent in the U.S. in 2009 for the medical care of heart failure patients. ADHF is a deadly condition, with in-hospital mortality rates of 2-6 percent and six month readmission rates as high as 30-60 percent. Episodes of ADHF are marked by a severe reduction of cardiac function that typically results in fluid accumulation in the lungs and consequent severe shortness of breath and worsening renal function due to poor perfusion of the kidneys. There were 1.1 million hospitalizations for acute heart failure in the U.S. in 2006. Among patients hospitalized with ADHF, the thirty day mortality rate is approximately 11 percent and the one year mortality rate is 34 percent. These poor outcomes indicate the clear need for better therapies to treat this patient population.
Previous therapies have focused on pharmacologic mechanisms that have not changed significantly over the last several decades.
About Cardioxyl Pharmaceuticals
Cardioxyl Pharmaceuticals is a clinical-stage pharmaceutical company focused on the discovery and development of new classes of safe and effective therapeutic agents for the treatment of cardiovascular disease. Cardioxyl has developed industry-leading expertise in the chemistry, biology and clinical applications of nitroxyl (HNO) technology. The company's core HNO platform has generated several pre-clinical and clinical candidates, including the company's lead compound, CXL-1020, currently in clinical development for ADHF. Cardioxyl is a privately held company financed by life science venture investors, including the Aurora Funds and New Enterprise Associates.
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