Ambrisentan ARIES-2 Data to Be Presented at ATS 2006 -- San Diego
02 3월 2006 - 10:00PM
Business Wire
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.
Myogen (NASDAQ:MYOG)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
Myogen (NASDAQ:MYOG)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024