DENVER, Jan. 8 /PRNewswire-FirstCall/ -- Myogen, Inc. (Nasdaq: MYOG)
announced today that it has begun patient enrollment in the pivotal phase III
clinical trials of ambrisentan for the treatment of pulmonary arterial
hypertension ("PAH"). The trials, ARIES I & II, follow successful completion
in September 2003 of a phase II dose-ranging trial, which demonstrated a
statistically significant and clinically meaningful increase in the primary
efficacy endpoint (exercise capacity measured by six-minute walk test
distance) in all four ambrisentan dose groups tested.
"This is a comprehensive trial design that will evaluate the safety and
efficacy of ambrisentan in treating PAH patients," stated J. William Freytag,
President and CEO of Myogen. "The rapidity with which ARIES I & II began
enrolling patients is encouraging given some of the challenges we face
regarding competing trials and the availability of existing medications. We
hope that we can maintain this early momentum throughout the remainder of the
studies."
Study Design
ARIES I & II are randomized, double-blind, placebo-controlled trials of
ambrisentan in patients with PAH. The trials are identical except for the
doses of ambrisentan and the geographic locations of the investigative sites.
The study design anticipates enrolling 186 patients (62 patients per dose
group) for each trial. ARIES I will evaluate ambrisentan doses of 5.0 mg and
10.0 mg administered orally once-a-day for 12 weeks to patients in the United
States and Canada. ARIES II will evaluate ambrisentan doses of 2.5 mg and
5.0 mg administered orally once-a-day for 12 weeks to patients in Europe and
South America. The primary efficacy endpoint is exercise capacity, measured
as the change from baseline in the six-minute walk test distance compared to
placebo. Secondary endpoints include Borg Dyspnea Index, WHO Functional Class
and a Quality of Life Assessment.
About Pulmonary Arterial Hypertension
PAH is a highly debilitating disease of the lungs characterized by severe
constriction of the blood vessels in the lungs leading to very high pulmonary
arterial pressures. These high pressures make it difficult for the heart to
pump blood through the lungs to be oxygenated. Patients with PAH suffer from
extreme shortness of breath as the heart struggles to pump against these high
pressures causing such patients to ultimately die of heart failure. PAH can
occur with no known underlying cause, or it can occur secondary to diseases
like scleroderma (an autoimmune disease of the connective tissues), cirrhosis
of the liver, congenital heart defects and HIV infection. PAH afflicts
approximately 40,000 patients, predominantly women, in the United States.
About Ambrisentan
Ambrisentan is a type-A selective endothelin receptor antagonist and
potent inhibitor of endothelin-induced vasoconstriction. Endothelin is a
small peptide hormone that is believed to play a critical role in the control
of blood flow and cell growth. Elevated endothelin blood levels are
associated with several cardiovascular disease conditions, including pulmonary
arterial hypertension, chronic kidney disease, hypertension, chronic heart
failure, stroke and reclosure of coronary arteries after balloon angioplasty
or stent implantation. Therefore, many scientists believe that agents that
block the detrimental effects of endothelin will provide significant benefits
in the treatment of these conditions. Ambrisentan is selective for the ET(A)
receptor versus the ET(B) receptor and demonstrates high potency, high
bioavailability, a half-life that may be suitable for once-a-day dosing, no
observed drug-drug interaction and, in the recent phase II study, a low
incidence of potential liver toxicity as assessed by liver function tests.
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 is
developing three product candidates for three distinct cardiovascular
indications. 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 our 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
Prospectus filed on October 30, 2003 and in our Form 10-Q filed on December 4,
2003. 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. Results from earlier clinical trials are not
necessarily predictive of future clinical results, and there can be no
assurance that these trials, if completed, will be successful in demonstrating
safety and efficacy. 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. If the
Company's product candidates do not meet safety or efficacy endpoints in
clinical evaluations, they will not receive regulatory approval and the
Company will be unable to market them. Consequently, there can be no
assurance that any particular product candidate will be successful and become
a commercial product. Endothelin receptor antagonists, including ambrisentan,
have demonstrated toxicity in animals. 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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