Lung Rx to expand Triumph study

By Elaine Rigoli

Tampa, Fla., June 12 - Lung Rx, Inc., a wholly owned subsidiary of United Therapeutics Corp., said the Food and Drug Administration has agreed to allow the inclusion of NYHA class 3 and 4 patients with pulmonary arterial hypertension (PAH) receiving stable doses of Revatio (sildenafil citrate) monotherapy into the Triumph study.

The study was previously limited to NYHA class 3 and 4 patients with PAH receiving stable doses of Tracleer (bosentan) monotherapy.

The FDA has also agreed to an increase in the size of the study to 200 evaluable patients from 150 patients, and to permit an interim analysis after 150 patients have completed the study, according to a news release.

The amendment also proposed an interim analysis of data upon completion of 100 patients, but the FDA advised Lung Rx to forego this analysis because, even if statistical significance were achieved for the primary endpoint, 100 patients may be insufficient to adequately explore secondary efficacy endpoints, the release said.

Lung Rx also said Monday that that company has appointed Eugene Sullivan as chief medical officer.

Located in Silver Spring, Md., United Therapeutics is a biotechnology company focused on the development of products for patients with chronic and life-threatening cardiovascular, cancer and infectious diseases.

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