MYOGEN COMPLETES ENROLLMENT FOR PHASE 3 ARIES-2 TRIAL.
"The completion of patient enrollment in ARIES-2 is an important milestone for ambrisentan and Myogen," said J. William Freytag, president and CEO 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.
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.
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.
For more information, visit http://www.myogen.com or call 303/464-3986.
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|Date:||Sep 1, 2005|
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