Source: Marketwire
Friday, July 03, 2009
HUNT VALLEY, MD--(Marketwire - July 01, 2009) - Cardioxyl Pharmaceuticals, Inc., a clinical
stage pharmaceutical company developing therapeutic agents for the
treatment of cardiovascular disease, today announced the initiation of a
Phase I/IIa dose-escalation study of lead drug candidate, CXL-1020, for the
treatment of acute decompensated heart failure (ADHF). The study has
already begun enrollment, and the first patient was dosed in June 2009.
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The Phase I/IIa dose-escalation study will evaluate the safety and
tolerability of CXL-1020 and specific effects on non-invasive hemodynamic
parameters in patients with chronic stable heart failure. The study will
also evaluate the pharmacokinetics of CXL-1020.
Chris Kroeger, MD, President and Chief Executive Officer of Cardioxyl
Pharmaceuticals, commented, "There is significant clinical need for a safe
and effective therapy to treat acute decompensated heart failure patients
that would enhance both diastolic and systolic function, while
concomitantly reducing vascular resistance." Kroeger continued, "CXL-1020
is a novel, first-in-class, small molecule nitroxyl (HNO) donor therapeutic
drug candidate. Our initial studies in patients with stable heart failure
are anticipated to provide a window through which we hope to better
understand the potential utility of this novel agent in acute decompensated
heart failure."
Wilson S. Colucci, MD of the Boston University Medical Center
Cardiovascular Center and Steering Committee Chair commented, "In
preclinical trials, CXL-1020 has exhibited a very attractive suite of
physiologic effects in canine models of heart failure. We look forward to
evaluating the safety and tolerability, as well as the hemodynamic effects
of CXL-1020 in this dose-escalation study."
About CXL-1020 Phase I/IIa Study
The study is a multi-center trial that will be conducted in up to 6 sites
in the U.S. with affiliated heart failure specialty centers or academic
medical centers. The Phase I/IIa study will enroll up to 4 cohorts and 36
subjects with chronic stable heart failure, who will receive escalating
doses of a sustained intravenous infusion. The primary endpoints for this
study are the evaluation of the safety and tolerability of CXL-1020.
About Nitroxyl (HNO)
Cardioxyl has developed a nitroxyl chemistry platform technology that
serves as the foundation for the company's drug discovery efforts. The
work of Cardioxyl's scientific founders at Johns Hopkins University and
colleagues elucidated the cardiovascular effects of nitroxyl in 2003, and
Cardioxyl has since developed a formidable intellectual property portfolio
and industry leading nitroxyl chemistry, pharmacology, manufacturing and
formulation expertise. Cardioxyl's lead program is focused on the
development of proprietary nitroxyl donors for the treatment of acute
decompensated heart failure (ADHF).
About Congestive Heart Failure (CHF)
Congestive heart failure is the inability of the heart to pump enough blood
to supply the metabolic demands of the body. Heart failure may result
either from the heart's inability to effectively contract (systolic heart
failure), or from the heart's inability to relax and fill with blood
(diastolic heart failure). There are more than 5.7 million people in the
U.S. and more than 22 million people world-wide with congestive heart
failure (CHF), with over 650,000 new CHF diagnoses each year in the U.S.
The prognosis for patients with CHF remains poor, with a
5-year mortality rate of 50 percent following diagnosis. The expected
economic impact of the medical care for CHF is substantial, with over $37
billion spent in the U.S. in 2009 for the medical care of heart failure
patients.
About Acute Decompensated Heart Failure (ADHF)
ADHF is an acute exacerbation of congestive heart failure and 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. 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 diminution of cardiac function that typically result 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 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.
Current Treatments for ADHF
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 nitroxyl (HNO) 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, including the Aurora Funds and
New Enterprise Associates.
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Jong, P et al. Prognosis and Determinants of Survival in Patients Newly
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