Phase 2 Trial Results of Ambrisentan in Pulmonary Arterial Hypertension
Published in the Journal of the American College of Cardiology (JACC)
DENVER, Aug. 11 /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 publication of the results from
a Phase 2 trial of ambrisentan in patients with pulmonary arterial
hypertension (PAH) in this month's issue of the Journal of the American
College of Cardiology. In addition, this month's issue of Future Cardiology
contains a review article describing the potential of ambrisentan as a new
treatment for patients with PAH.
Dr. Nazzareno Galie, Professor of Cardiology at the University of Bologna,
Bologna, Italy, as the lead author on behalf of the Ambrisentan PAH Study
Group, published "Ambrisentan Therapy for Pulmonary Arterial Hypertension"
(J Am Coll Cardiology 2005;46:529-535). In this manuscript, Dr. Galie
describes the efficacy and safety results of four doses of ambrisentan, an
oral endothelin type A receptor-selective antagonist (ERA), in patients with
PAH. After 12 weeks of treatment, ambrisentan increased 6-minute walk
distance by +36.1 meters (p< 0.0001) with similar and statistically
significant increases for each dose group (range, +33.9 to +38.1 meters).
Improvements were also observed in the Borg dyspnea index, WHO functional
class, subject global assessment, mean pulmonary arterial pressure (-5.2 mmHg,
p<0.0001), and cardiac index (+0.331/min/m-squared, p<0.0008). Adverse events
were mild and unrelated to dose, including the incidence of elevated serum
aminotransferase concentrations >3 times the upper limit of normal (3.1%).
The publication concludes that ambrisentan appears to improve exercise
capacity, symptoms and hemodynamics in patients with WHO class II to III PAH
and that ambrisentan may have a very favorable efficacy-to-safety ratio in
patients with PAH, including a low incidence and severity of serum
aminotransferase abnormalities which does not appear to be dose-dependent.
Dr. Lewis Rubin, Professor of Medicine, Pulmonary Vascular Center,
University of California, San Diego, published a review article titled
"Ambrisentan for Pulmonary Arterial Hypertension" in Future Cardiology
(Future Cardiol 2005 1(4), 1-8). The publication reviews endothelin receptor
antagonists as an important class of agents in the treatment of PAH and
ambrisentan as an oral, once-daily, endothelin type A receptor-selective,
propanoic acid class ERA in Phase 3 clinical development for the treatment of
PAH. The article also reviews the absence of relevant interactions between
ambrisentan and cytochrome P450 isoenzymes (metabolism, induction or
inhibition) that might alter the activity of P450-metabolized drugs. The
publication summarizes potential benefits of ambrisentan including, oral,
once-daily dosing, ET(A)-receptor selectivity and the decreased risks of liver
toxicity and adverse drug-drug interactions compared with other ERAs.
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 two
product candidates in late-stage clinical development: ambrisentan for the
treatment of patients with pulmonary arterial hypertension and darusentan for
the treatment of patients with resistant hypertension. The Company, in
collaboration with Novartis, 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 the statements relating to the
Company's ambrisentan clinical data. Actual results could differ materially
from those projected and Myogen cautions investors not to place undue reliance
on the forward-looking statements contained in this release.
The results of Myogen's prior clinical trials of its product candidates,
including ambrisentan, do not necessarily predict the results of later-stage
clinical trials, including the results of the Company's current ARIES-1 &
ARIES-2 clinical trials. Results of the Company's current and former
ambrisentan clinical trials may not be confirmed upon full analysis of the
detailed results of a trial. There can be no assurance that Myogen's product
candidates, including ambrisentan, have better safety profiles than competing
products, including a lower incidence of liver toxicity or liver toxicity that
is not dose dependent. Among other things, Myogen's results may be affected
by competition from other pharmaceutical and biotechnology companies, Myogen's
ability to successfully develop and market its current products, difficulties
or delays in its clinical trials, regulatory developments involving current
and future products and its effectiveness at managing its financial resources.
If the Company's product candidates, including ambrisentan and darusentan, do
not meet the safety or efficacy endpoints in clinical evaluations, they will
not receive regulatory approval and the Company will not be able to market
them. Even if Myogen's product candidates meet safety and efficacy endpoints,
regulatory authorities may not approve them, or the Company may face
post-approval problems that require the withdrawal of its products from the
market. 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.
Additional risks and uncertainties relating to the company and its
business can be found in the "Risk Factors" section of Myogen's Form 10-K for
the year ended December 31, 2004 and Myogen's periodic reports on Form
10-Q and Form 8-K. It is Myogen's policy to only update or confirm its public
guidance by issuing a press release or filing a periodic or current report
with the Securities and Exchange Commission. The Company generally plans to
provide guidance as part of its annual and quarterly earnings releases but
reserves the right to provide guidance at different intervals or to revise its
practice in future periods. Myogen undertakes no duty or obligation to update
any forward-looking statements contained in this release as a result of new
information, future events or changes in the Company's expectations. The
Company also disclaims any duty to comment upon or correct information that
may be contained in reports published by the investment community.
SOURCE Myogen, Inc.
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Related links:
http://www.myogen.com
CONTACT:
Derek K. Cole, Director, Investor Relations
of Myogen, Inc., +1-303-464-3986, derek.cole@myogen.com
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