SOURCE Cardioxyl Pharmaceuticals, Inc.
Cardioxyl now evaluating clinical safety and tolerability of improved second-generation HNO prodrug targeting acute decompensated heart failure
CHAPEL HILL, N.C., Feb. 25, 2014 /PRNewswire/ -- Cardioxyl Pharmaceuticals, Inc. announced today that the first cohort of patients has been dosed in a Phase I clinical trial of CXL-1427, a novel nitroxyl (HNO) prodrug optimized for clinical development as a potential treatment for acute decompensated heart failure (ADHF). The primary objective of the Phase 1 clinical trial is to evaluate the safety and tolerability of continuous intravenous infusions of CXL-1427 for up to 48-hours in healthy volunteers.
"We have demonstrated a very attractive preclinical profile for CXL-1427, with pharmacodynamic results comparable to our first-generation nitroxyl prodrug," said ShiYin Foo, M.D., Ph.D., Cardioxyl Pharmaceuticals' Chief Medical Officer. "We are excited to advance this second-generation nitroxyl prodrug into the clinic and believe that CXL-1427 has the potential to be an important new therapy for patients with ADHF."
This Phase I trial of CXL-1427, which is set to be conducted over the first half of 2014, is a randomized, double-blind, placebo-controlled ascending dose evaluation of CXL-1427 in healthy volunteers. The study will enroll up to a total of 110 subjects and will evaluate the safety and pharmacokinetics of 24- and 48-hour infusions of CXL-1427.
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. Despite the prevalence and severity of the condition, the treatment options available for patients with ADHF remain limited.
Pending successful completion of this Phase 1 trial, Cardioxyl anticipates initiating subsequent trials of CXL-1427 in patients with acute decompensated heart failure.
CXL-1427 is a novel, improved second-generation prodrug that breaks down chemically to produce nitroxyl (HNO) and an inactive byproduct following intravenous administration. In extensive pre-clinical testing and in a Phase IIa human proof of concept study with Cardioxyl's first-generation prodrug, HNO has been shown to produce a unique and very attractive hemodynamic profile. The novel combination of effects produced by Cardioxyl's HNO prodrugs distinguishes them from other therapies used in the treatment of congestive heart failure and provides a strong rationale for continuing the development of this important new class of drugs.
About Cardioxyl Pharmaceuticals
Cardioxyl Pharmaceuticals is 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. Cardioxyl is a privately held company financed by life science venture investors, including New Enterprise Associates, OrbiMed, Aurora Funds and Osage University Partners.
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