Top Line Results of Trial Expected by Year-End
DENVER, July 21 /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 completion of enrollment of 187
patients in ARIES-2, one of the Company's two pivotal Phase 3 trials of
ambrisentan in patients with pulmonary arterial hypertension (PAH). The
Company expects to report top line results of the trial by the end of this
year. In addition, the Company expects to complete patient enrollment in
ARIES-1 in the fourth quarter of 2005 and report top line results
approximately six months thereafter.
"The completion of patient enrollment in ARIES-2 is an important milestone
for ambrisentan and Myogen," said J. William Freytag, President and Chief
Executive Officer of Myogen. "We are gratified by the support and confidence
of the patients and clinical investigators participating in the ARIES trials.
Based on the properties of the compound and the results of our Phase 2 trial,
we believe ambrisentan's efficacy and safety profile may position it as the
best-in-class among endothelin receptor antagonists. We are excited by the
progress of our ambrisentan clinical program and look forward to sharing the
results of the ARIES-2 trial later this year."
In January 2004, Myogen initiated two pivotal Phase 3 clinical trials,
ARIES-1 and ARIES-2, evaluating the safety and efficacy of ambrisentan in
patients with PAH. The ARIES trials are randomized, double-blind, placebo-
controlled trials of identical design except for the doses of ambrisentan and
the geographic locations of the investigative sites. Both trials are designed
to enroll 186 patients (62 patients per dose group). ARIES-1 evaluates doses
of 5.0 milligrams and 10.0 milligrams of ambrisentan administered orally once
per day and ARIES-2 evaluates doses of 2.5 milligrams and 5.0 milligrams of
ambrisentan administered orally once per day. The primary efficacy endpoint
is exercise capacity, measured as the mean change from baseline at 12 weeks in
the six-minute walk test compared to placebo. Secondary endpoints include
time to clinical worsening, World Health Organization (WHO) Functional Class
and Borg Dyspnea Index. ARIES-1 is enrolling patients primarily from North
America plus selected international sites, while ARIES-2 enrolled patients
primarily in Europe plus selected international sites.
In September 2003, Myogen reported results of a Phase 2 clinical trial of
ambrisentan in patients with PAH. Based on those results and results of the
associated extension study, Myogen believes ambrisentan's profile may position
it as the best-in-class endothelin receptor antagonist with demonstrated:
* Significant improvements in six-minute walk distance, Borg Dyspnea
Index and WHO Functional Class
* Durable efficacy with long-term use and a possible survival benefit
* Comparable efficacy in WHO Functional Class 2 and Class 3 patients
* Selectivity for the endothelin type-A receptor
* Dose flexibility
* True once-daily dosing
* No drug-drug interactions (no p450 induction or inhibition)
* Low incidence and severity of potential liver toxicity that does not
appear to be dose related
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 50,000 patients, predominantly women, in the United States.
About Ambrisentan
Ambrisentan is being developed as an 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.
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 renal disease, coronary artery disease,
hypertension and chronic heart failure. Therefore, the Company believes that
agents that block the detrimental effects of endothelin may provide
significant benefits in the treatment of these conditions.
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 statements relating to
ambrisentan clinical data and the completion and release of results of the
Company's ARIES clinical trials. 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 completion of the Company's clinical
trials, including the ARIES trials, 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. Delays in 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. 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 ARIES-1
and ARIES-2 clinical trials. Top line results of a clinical trial may not be
confirmed upon full analysis of the detailed results of the trial. If the
Company's product candidates, including ambrisentan, 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, or the Company may face post-approval
problems that require the withdrawal of its product from the market. 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.
Myogen's results may also be affected by competition from other pharmaceutical
and biotechnology companies, Myogen's ability to successfully develop and
market its current products, regulatory developments involving current and
future products and its effectiveness at managing its financial resources. 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. 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. All information in this press release is as of July 21,
2005. 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.
 back to top
Related links:
http://www.myogen.com
CONTACT:
Derek K. Cole, Director, Investor Relations
of Myogen, Inc., +1-303-464-3986, derek.cole@myogen.com
|
