Myogen (NASDAQ:MYOG)
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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 that an abstract describing the effects of ambrisentan
in patients with pulmonary arterial hypertension (PAH) has been
selected for presentation at ATS 2006 -- San Diego, the annual
International Conference of the American Thoracic Society to be held
May 19-24, 2006 at the San Diego Convention Center in San Diego,
California.
The abstract highlights efficacy and safety results from ARIES-2,
the Phase 3 trial of ambrisentan in 192 patients with PAH. The data
demonstrate that ambrisentan improved exercise capacity, delayed
clinical worsening and improved symptoms in patients with PAH.
Ambrisentan was well tolerated and was not associated with any
clinically significant serum aminotransferase abnormalities.
Horst Olschewski, M.D., will present "Ambrisentan Improves
Exercise Capacity and Time to Clinical Worsening in Patients with
Pulmonary Arterial Hypertension: Results of the ARIES-2 Study." This
abstract has been selected for an oral presentation at a Mini
Symposium Session, C85, "Clinical Management and Therapy of Pulmonary
Hypertension," Tuesday, May 23, 2006, between 1:30 p.m. and 4:15 p.m.
(Pacific). Dr. Olschewski is Professor of Medicine, Division of
Pulmonology, Medical University Graz, Austria and a principal
investigator for ARIES-2.
Myogen reported the top line results of the trial in December
2005. The primary efficacy endpoint of the ARIES-2 trial was the
placebo-corrected mean change in six-minute walk distance (6MWD) at
week 12 compared to baseline. Results of the trial demonstrated that
with once-daily dosing, 5 mg of ambrisentan improved the
placebo-corrected mean 6MWD by 59.4 meters (p=0.0002) and 2.5 mg of
ambrisentan improved the placebo-corrected mean 6MWD by 32.3 meters
(p=0.0219). For the placebo group, the mean 6MWD at week 12 decreased
from baseline by 10.1 meters. Improvements in time to clinical
worsening compared to placebo were observed for both the 5 mg dose
group (p=0.0076) and the 2.5 mg dose group (p=0.0048).
The trial safety results demonstrated ambrisentan was generally
well tolerated. The most frequent adverse event was headache, which
occurred in 12.7% of patients in the 5 mg dose group and 7.8% in the
2.5 mg dose group, compared to 6.2% in the placebo group. No patients
treated with ambrisentan developed serum aminotransferase
concentrations greater than three-times the upper limit of the normal
range, compared to one patient in the placebo group. Ambrisentan had
no apparent effect on the activity or dosage of warfarin-type
anticoagulants commonly prescribed for patients with PAH.
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 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 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 www.myogen.com.
Safe Harbor Statement
This press release contains forward-looking statements that
involve significant risks and uncertainties, including summary
statements relating to the results of the Company's ARIES-2 clinical
trial. Actual results could differ materially from those projected and
the Company cautions investors not to place undue reliance on the
forward-looking statements contained in this release.
Results from clinical trials, including the Company's ARIES-2
trial, are not necessarily predictive of future clinical results. Top
line results may not be confirmed upon full analysis of the detailed
results of a trial and additional information relating to the safety,
efficacy or tolerability of the Company's product candidates,
including ambrisentan, may be discovered upon further analysis of
trial data and upon review and analysis of additional trial data,
including data from the Company's ARIES-1 clinical trial. 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 not be able to market them. Even if the Company's
product candidates meet safety and efficacy endpoints, regulatory
authorities may not approve them, the Company may not be able to
successfully market them, or the Company may face post-approval
problems that require the withdrawal of its product from the market.
The Company's results may be affected by its effectiveness at managing
its financial resources, its ability to successfully develop and
market its product candidates, its ability to obtain and enforce
patent protection for its products, competition from other
biotechnology and pharmaceutical companies, difficulties or delays in
manufacturing its products, and regulatory developments involving
current and future products. Delays in initiating or conducting
clinical trials, whether caused by competition, adverse events,
patient enrollment rates, regulatory issues or other factors, could
adversely affect the Company's financial position and prospects. 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 reports on Form
10-Q and Form 8-K. It is Myogen's policy to only update or reconfirm
its public guidance by issuing a press release or filing a periodic or
current report with the Securities and Exchange Commission. All
information in this press release is as of March 2, 2006. 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.