DENVER, Feb. 6 /PRNewswire/ -- Myogen, Inc., a Colorado-based
biopharmaceutical company dedicated to discovering, developing and
commercializing drugs for the treatment of heart failure and related
cardiovascular complications, announced today that it commenced patient
enrollment in its pivotal Phase III clinical trial of low dose oral enoximone
in patients with advanced heart failure. This study is referred to as
"ESSENTIAL". Myogen plans to conduct ESSENTIAL in approximately 240 sites in
North and South America and Western and Eastern Europe. The Phase III
program, if successful, is expected to be sufficient to support regulatory
registration of enoximone on a worldwide basis.
In this randomized, placebo-controlled multi-center trial, it is expected
that approximately 1400 patients suffering from NYHA Class III & IV chronic
heart failure will be treated with either placebo or oral enoximone (25 or
50 mg t.i.d.) for at least 52 weeks. The Phase III trial will assess the
safety and efficacy of oral enoximone in reducing the incidence of death or
cardiovascular hospitalizations, improving patient well-being, and increasing
exercise capacity.
"The commencement of ESSENTIAL is an important development and corporate
milestone for Myogen," stated J. William Freytag, President and Chief
Executive Officer of Myogen. "In addition, we have reached the halfway point
in the EMOTE trial, our first Phase III trial of low dose oral enoximone.
EMOTE is a randomized, placebo-controlled trial of 200 patients suffering from
ultra-advanced heart failure, and is designed to assess the safety and
efficacy of oral enoximone in reducing patients' dependency on intravenous
inotropes as well as the incidence of death or cardiovascular
hospitalizations."
"There are few therapies available today for the palliation of advanced
heart failure. If enoximone proves to be safe and effective it will be one of
the more important new therapies available for these patients," stated Michael
Bristow, MD, PhD, Chief of Cardiology at the University of Colorado Health
Sciences Center in Denver, and Myogen Chief Science and Medical Officer.
Chronic heart failure (CHF) is a debilitating condition that occurs as the
heart becomes progressively less able to pump an adequate supply of blood
throughout the body. CHF has many causes, generally beginning in patients
with a life-long history of high blood pressure or after a patient has
suffered a major heart attack or some other heart-damaging event. CHF itself
may lead to other complicating factors such as pulmonary hypertension, edema,
pulmonary edema, liver dysfunction and kidney failure. CHF is one of the
largest health problems in the developed world, with costs in the United
States alone exceeding $30 billion annually. In the United States,
approximately five million patients are afflicted with CHF, with an additional
550,000 new cases reported each year. It is estimated that half of all CHF
patients die within five years of diagnosis.
Myogen is a privately held biopharmaceutical company engaged in the
discovery and development of drugs for the treatment of heart failure and
related cardiovascular conditions. The company's strategy aims to leverage
its research and clinical expertise in heart muscle disease toward the
development of a portfolio of novel cardiovascular therapeutics. The company
is currently evaluating two drugs in human clinical studies: enoximone, a
positive inotropic agent that increases the force of contraction of the heart,
and ambrisentan, a member of a new class of drugs referred to as endothelin
receptor antagonists, which the Company intends to develop for the treatment
of chronic heart failure, chronic renal failure, and pulmonary arterial
hypertension. Myogen sells Perfan(R)I.V., the intravenous form of enoximone,
in Europe. In addition, Myogen's research efforts have identified several
novel therapeutic targets involved in heart failure for which the company has
begun drug discovery efforts. Myogen occupies 30,000 square feet of
laboratory and office space in the Denver, Colorado area and currently has
approximately 40 employees. Please visit our website at http://www.myogen.com .
SOURCE Myogen, Inc.
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Related links:
http://www.myogen.com
CONTACT:
J. William Freytag, Ph.D., President & CEO,
+1-303-464-5221, or Joseph L. Turner, Chief Financial Officer,
+1-303-464-5222, both of Myogen, Inc.
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