Myogen Initiates Open-Label Phase 3 Clinical Trial of Ambrisentan in Patients with Pulmonary Hypertension
September 07 2006 - 8:00AM
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 the initiation of ARIES-3 (AMB-323), a Phase 3 long-term,
open-label safety and efficacy study of ambrisentan in a broad
population of patients with pulmonary hypertension (PH). The
primary objective of this study is to evaluate the effect of
ambrisentan on exercise capacity in a broad population of patients
with PH. The primary endpoint of the trial is the change from
baseline in six-minute walk distance (6MWD) at week 24. Secondary
endpoints include: clinical worsening of pulmonary hypertension,
change from baseline in World Health Organization (WHO) functional
class, SF-36(R) health survey and the Borg dyspnea index.
Ambrisentan has demonstrated a statistically significant
improvement in 6MWD in prior clinical trials in patients with
pulmonary arterial hypertension (PAH), including a Phase 2 trial
and two Phase 3, placebo-controlled, multi-center trials. The
results from these prior trials form the foundation of the
ambrisentan New Drug Application (NDA), which is expected to be
submitted to the U.S. Food and Drug Administration (FDA) in the
fourth quarter of 2006. The ARIES-3 trial is evaluating ambrisentan
in pulmonary hypertension, one of several additional indications
beyond PAH in which ambrisentan may have utility. Myogen does not
anticipate including data from the ARIES-3 trial in the original
ambrisentan NDA submission. "This study will evaluate the safety
and efficacy of ambrisentan in both a broader pulmonary
hypertension patient population and in traditional PAH patients,"
said Dr. Michael J. Gerber, Senior Vice President, Clinical
Development and Regulatory Affairs. "The efficacy and safety of
ambrisentan observed in the traditional PAH population, and the
need for effective therapy in pulmonary hypertension associated
with other causes, merits evaluation of ambrisentan in these
non-traditional groups." ARIES-3 will enroll up to 200 patients in
PH subgroups, including: PH associated with interstitial lung
disease (ILD); PH due to chronic thromboembolic disease or sickle
cell disease; PH associated with chronic obstructive pulmonary
disease (COPD); PAH associated with congenital heart defects; and
PAH associated with HIV infection. The trial will also enroll
patients with PAH receiving prostacyclin or sildenafil therapy at
baseline, and patients who previously discontinued either bosentan,
sitaxsentan, or both, due to liver function test abnormalities.
About Pulmonary Hypertension (PH) Pulmonary hypertension is a
highly debilitating disease 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 PH 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. PH is categorized into
five subgroups: PAH, PH with left-heart disease, PH associated with
lung diseases and/or hypoxemia, PH due to chronic thrombotic and/or
embolic disease and miscellaneous forms of PH. About Ambrisentan
Ambrisentan is an investigational drug being developed as a once
daily oral therapy for patients with PAH and has been granted
orphan drug designation for the treatment of PAH in both the United
States and European Union. GlaxoSmithKline licensed commercial
rights for ambrisentan outside of the United States. Ambrisentan is
a non-sulfonamide, propanoic acid-class, type-A selective
endothelin receptor antagonist. Endothelin is a small peptide
hormone that plays a critical role in the control of blood flow and
cell growth. Elevated endothelin blood levels are associated with
several cardiovascular disease conditions, including PAH, chronic
renal disease, coronary artery disease, hypertension and chronic
heart failure. Myogen believes that agents that block the
detrimental effects of endothelin may provide significant benefits
in the treatment of these conditions. About Myogen Myogen has two
product candidates in late-stage clinical development: ambrisentan
for the treatment of patients with pulmonary arterial hypertension
(PAH) and darusentan for the treatment of patients with resistant
hypertension. Myogen and GlaxoSmithKline have entered into a global
PAH collaboration in which Myogen has marketing and distribution
rights to GlaxoSmithKline's Flolan(R) (epoprostenol sodium) for
Injection in the United States and GlaxoSmithKline has licensed
ambrisentan from Myogen for all territories outside of the United
States, where Myogen retains exclusive rights. Myogen 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 statements relating
to ambrisentan clinical data, the enrollment and completion of the
Company's ARIES-3 clinical trials and expected timing of submission
of the ambrisentan NDA. 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. Among other things, the projected enrollment of the
Company's clinical trials, including the ARIES-3 trial, and the
timing of the release of results of clinical trials may be affected
by difficulties or delays, including difficulties or delays in
patient enrollment, patient treatment, data collection and data
analysis. The results of Myogen's prior clinical trials of its
product candidates, including ambrisentan, do not necessarily
predict the results of future clinical trials. Preliminary results
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. 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, 2005, and Myogen's periodic reports
on Form 10-Q and Form 8-K. Myogen does not undertake any obligation
to update any forward-looking statements contained in the
anticipated presentation 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 or the presentation. No forward-looking statement can
be guaranteed and actual events and results may differ materially
from those projected.
Myogen (NASDAQ:MYOG)
Historical Stock Chart
From Aug 2024 to Sep 2024
Myogen (NASDAQ:MYOG)
Historical Stock Chart
From Sep 2023 to Sep 2024