Cardioxyl Pharmaceuticals Announces Positive Results from First Clinical Study of its Lead Therapy, CXL-1020, in Heart Failure Patients
Company Also Secures an Additional $15 Million in Funding
CHAPEL HILL, N.C., Aug. 2 /PRNewswire/ -- Cardioxyl Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel therapeutic agents for the treatment of cardiovascular disease, today announced that it has achieved positive safety and tolerability results in the first clinical study of its lead drug candidate, CXL-1020, for the treatment of patients with acute decompensated heart failure (ADHF). Each year in the United States, more than one million patients are hospitalized with acute heart failure.
Cardioxyl's Phase I/IIa placebo-controlled, double-blind,
dose-escalation study was conducted at seven sites in the United
States with affiliated heart failure specialty centers or academic
medical centers. The Phase I/IIa study enrolled 28 subjects with
chronic stable heart failure and involved 67 exposures of a
sustained intravenous infusion across four cohorts. In the trial,
CXL-1020 demonstrated an acceptable safety profile, an attractive
pharmacokinetic profile, and was well tolerated by patients. The
drug led to no serious adverse events, with patients tolerating
doses up to 10 ug/kg/min. In addition, CXL-1020 clearly
demonstrated statistically significant hemodynamic activity in
patients with relevant underlying disease. More information on the
trial results will be presented at upcoming scientific
meetings.
"Cardioxyl is making significant clinical progress in the
development of CXL-1020, an important treatment for patients with
ADHF," said Chris Kroeger, M.D., President and Chief Executive
Officer. "Results from our recently completed Phase I/IIa dose
escalation study demonstrate that the drug has a very attractive
safety profile and an important impact on cardiac and vascular
function. We also believe that CXL-1020 is the only product in
development that provides the ideal balance of blood vessel
dilation combined with direct enhancement of cardiac diastolic and
systolic function."
Dr. Garrie J. Haas, M.D., FACC, Section Director of Heart
Failure/Transplant, and Medical Director of the Cardiovascular
Clinical Research Organization, Professor of Medicine in the
Division of Cardiovascular Medicine at The Ohio State University
Medical Center and an investigator in the Cardioxyl Phase I/IIa
trial stated, "There is currently a significant clinical need in
the United States for a safe and effective therapy to treat the
large population of hospitalized patients with heart failure. With
its unique mechanism of action as compared to the limited options
available on the market today, CXL-1020, if successful, will
provide a novel and very useful new therapy for the treatment of
these often severely ill patients."
Cardioxyl Raises an Additional $15 Million in Funding
Cardioxyl also announced today that it has raised $15 million in
funding from existing investors Aurora Funds and New Enterprise
Associates (NEA).
Said Dr. Kroeger, "With this additional funding, Cardioxyl is well
capitalized to execute on a Phase IIa trial for CXL-1020 and to
continue development of our promising research portfolio. We are
pleased to have the continued enthusiastic support of Aurora and
NEA."
About CXL-1020
Cardioxyl has developed a nitroxyl chemistry platform technology
that serves as the foundation for the company's drug discovery
efforts. In research published by Cardioxyl's scientific founders
from Johns Hopkins University, nitroxyl was shown to have positive
vasodilatory and direct myocardial effects. CXL-1020, a proprietary
nitroxyl donor, is Cardioxyl's lead compound for the intravenous
treatment of acute decompensated heart failure (ADHF). In
pre-clinical models of heart failure, CXL-1020 improves
cardiovascular performance by enhancing the contractility
(inotropy) and relaxation (lusitropy) of the failing heart and
dilating the peripheral vasculature (vasodilation), without
increasing heart rate or myocardial oxygen consumption. Cardioxyl
completed a Phase I/IIa safety and dose-escalation study of
CXL-1020 in stable chronic heart failure subjects and will soon
initiate a Phase IIa trial. 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) & 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. (1) Well over $39 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 two to
six percent and six-month readmission rates as high as 30 to 60
percent. Episodes of ADHF are marked by a severe reduction of
cardiac function that typically results in fluid accumulation in
the lungs (pulmonary edema) and consequent severe shortness of
breath. There were 1.1 million hospitalizations for acute heart
failure in the U.S. in 2006. Among patients hospitalized with ADHF,
the 30-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. (2,3)
Despite the severity of the condition, the treatment options
available for patients with ADHF remain limited. Current first-line
treatments target the removal of excess fluid (diuresis) and
preload and afterload reduction (vasodilation). In order to improve
the hemodynamic profile of the heart and increase cardiac
contractility, a physician may also administer an intravenous
inotropic agent such as dobutamine (beta-adrenergic agonist) or
milrinone (PDE3-inhibitor). Administration of dobutamine or
milrinone often requires very close monitoring in the hospital's
cardiac or intensive care unit setting due to the life-threatening
safety risks associated with these drugs, including
ventricular/atrial arrhythmias, hypotension, sudden cardiac death,
and other potential adverse long term outcomes.
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
HNO (nitroxyl) technology. The company's core HNO platform has
generated several preclinical 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 Aurora Funds and New
Enterprise Associates.
(1) Heart Disease and Stroke Statistics 2009 Update. A Report From
the American Heart Association Statistics Committee and Stroke
Statistics Subcommittee. Circulation. 2009; 119:e1-e161
(2) Gheorghiade, M. Reassessing treatment of acute heart failure
syndromes: the ADHERE Registry. Eur Heart J Suppl. 2005 7:
B13-B19
(3) Jong, P et al. Prognosis and Determinants of Survival in
Patients Newly Hospitalized for Heart Failure. Arch Int Med, 2002;
162:1689-1694
Source: Cardioxyl Pharmaceuticals, Inc.
CONTACT: Jamie Lacey-Moreira, +1-410-299-3310,
jamielacey@presscommpr.com, for Cardioxyl Pharmaceuticals
Web Site: http://www.cardioxyl.com/
Posted: August 2010
