Trials of Enoximone in Chronic Heart Failure Expected to be Completed
by Year-End
DENVER, May 20 /PRNewswire-FirstCall/ -- Myogen, Inc. (Nasdaq: MYOG), a
biopharmaceutical company focused on the discovery, development and
commercialization of small molecule therapeutics for the treatment of
cardiovascular disorders, today announced the completion of enrollment of
1,800 patients in ESSENTIAL I & II, the Company's two pivotal Phase III trials
of enoximone capsules in patients with advanced chronic heart failure. The
Company expects to complete the treatment phase of both trials before the end
of this year.
"The completion of patient enrollment in the ESSENTIAL trials is an
important milestone for Myogen," said J. William Freytag, President and Chief
Executive Officer of Myogen. "We are pleased at the level of physician and
patient interest in enoximone capsules that enabled us to enroll two
multi-national cardiovascular trials of this size in just over two years."
ESSENTIAL I & II are randomized, double-blind, placebo-controlled trials
of approximately 900 patients each, being conducted in North and South America
(ESSENTIAL I) and in Western and Eastern Europe (ESSENTIAL II). ESSENTIAL
I & II are identical trials differing only in the geographic location of the
study sites. Over 200 centers are taking part in these trials. Patient
enrollment for both trials began in the first half of 2002. The Company
expects that, on average, patients will receive treatment for at least 12
months. The trials will continue until there have been a total of 956 primary
endpoint events (cardiovascular hospitalization or all-cause mortality). The
Company expects that the specified number of events will have occurred by the
end of this year.
The ESSENTIAL trials are designed to evaluate the safety and efficacy of
low-dose enoximone capsules in patients with NYHA Class III and IV chronic
heart failure. Patients were randomized in a 1:1 ratio to receive either 25
mg of enoximone or placebo, administered three times a day (t.i.d.). In the
absence of contraindications after two weeks of treatment, all subjects
weighing greater than 50 kg received 50 mg of enoximone or placebo t.i.d.
Contraindications to study drug dose increase include significant hypotension,
arrythmias, or abnormal creatinine, potassium or bilirubin values beyond those
established in the exclusion criteria.
The ESSENTIAL trials have three primary endpoints: 1) time from
randomization to cardiovascular hospitalization or all-cause mortality, 2)
submaximal exercise capacity (six-minute walk distance), and 3) patient global
assessment. A cardiovascular hospitalization is defined as an admission due
to heart failure, myocardial infarction, myocardial ischemia, cerebral
vascular accident, atrial or ventricular dysrhythmias or symptomatic heart
block.
All cause mortality is also a secondary endpoint in the trials and the
major safety endpoint.
About Chronic Heart Failure
Chronic heart failure generally occurs in patients with a long history of
uncontrolled high blood pressure or in patients that have suffered a heart
attack or some other heart-damaging event. It is estimated that half of all
patients with this disorder die within five years of diagnosis. CHF is one of
the largest health problems in the developed world, with annual direct and
indirect healthcare costs in the United States alone exceeding $24 billion.
In the United States, approximately five million patients are afflicted with
chronic heart failure, with an additional 550,000 new cases reported each
year. CHF therapeutics are a $14 billion market that is expected to grow to
more than $22 billion in 2008.
As patients enter the advanced stages of chronic heart failure, Classes
III and IV, their cardiac function deteriorates, leading to an accumulation of
fluid in the lungs, referred to as pulmonary congestion. Eventually,
pulmonary congestion and the resulting breathlessness and fatigue reach a
critical point referred to as acute decompensated heart failure. At this
point the patient must be hospitalized and treated with powerful i.v.
diuretics, vasodilators and positive inotropes such as dobutamine, milrinone
or Perfan I.V., all of which serve to increase the efficiency of the
circulatory system, providing symptomatic relief. After stabilization and
discharge from the hospital, patients often decompensate again within months
and must be readmitted to the hospital for another round of i.v. treatment.
As their disease progresses, the frequency of decompensation and
hospitalization increases until patients must be maintained on continuous or
intermittent treatment with these i.v. agents.
About Enoximone
Enoximone is a small organic molecule that exhibits highly selective
inhibition of type-III phosphodiesterase, or PDE-III, an enzyme that is
present in the heart and plays an important regulatory role in cardiac
function. PDE-III inhibitors block the action of this enzyme, increasing the
force of contraction of the heart and increasing the rate of relaxation,
thereby increasing cardiac output. Compounds that increase the force of
contraction of the heart, like enoximone, are referred to as positive
inotropes. Enoximone also causes vasodilation, an increase in the diameter of
blood vessels, through its effects on smooth muscle cells that surround blood
vessels, which results in lower pressure against which the heart must pump.
Positive inotropy and vasodilation can both be therapeutically useful in the
treatment of heart failure.
About Myogen
Myogen is a biopharmaceutical company focused on the discovery,
development and commercialization of small molecule therapeutics for the
treatment of cardiovascular disorders. Myogen currently markets one product
in Europe for the treatment of acute decompensated heart failure and has three
product candidates in late-stage clinical development: enoximone capsules for
the treatment of chronic heart failure, ambrisentan for the treatment of
pulmonary arterial hypertension and darusentan for the treatment of resistant
hypertension. The Company also conducts a target and drug discovery research
program focused on the development of disease-modifying drugs for the
treatment of chronic heart failure and related cardiovascular disorders.
Please visit Myogen's website at http://www.myogen.com.
Safe Harbor Statement
This press release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed in this release
and others that can be found in the "Risk Factors" section of Myogen's Form
10-K for the year ended December 31, 2003 and in Myogen's periodic reports on
Form 10-Q and Form 8-K. Myogen is providing this information as of the date
of this release and does not undertake any obligation to update any
forward-looking statements contained in this document as a result of new
information, future events or otherwise.
The Company cautions investors not to place undue reliance on the forward-
looking statements contained in this press release. No forward-looking
statement can be guaranteed and actual events and results may differ
materially from those projected. The Company's results may be affected by its
effectiveness at managing its financial resources, its ability to successfully
develop and market current and new products, difficulties or delays in its
clinical trials, difficulties or delays in manufacturing its products, and
regulatory developments involving current and future products. Delays in
clinical trials, whether caused by adverse events, patient enrollment rates,
regulatory issues or other factors, could adversely affect the Company's
financial position and prospects. Results from earlier clinical trials are
not necessarily predictive of future clinical results. Trials that are
designed to continue until a pre-specified number of events have occurred are
subject to delays stemming from patient withdrawal and from lower than
expected event rates. If the Company is unable to raise additional capital
when required or on acceptable terms, it may have to significantly delay,
scale back or discontinue one or more of its drug development or discovery
research programs. Myogen is at an early stage of development and may not ever
have any products that generate significant revenue.
SOURCE Myogen, Inc.
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Related links:
http://www.myogen.com
CONTACT:
Derek K. Cole, Director, Investor Relations,
+1-303-464-3986, derek.cole@myogen.com, or Joseph L. Turner,
Chief Financial Officer, +1-303-464-5222, joe.turner@myogen.com,
both of Myogen, Inc.
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