SILVER SPRING, Md., June 12 /PRNewswire-FirstCall/ -- Lung Rx, Inc., a wholly-owned subsidiary of United Therapeutics Corporation , today announced the FDA response to a protocol amendment request for its ongoing TRIUMPH (TReprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension) study.
The FDA has agreed with Lung Rx to allow the inclusion of NYHA Class III and IV patients with pulmonary arterial hypertension (PAH) receiving stable doses of Revatio(R) (sildenafil citrate) monotherapy into the study. The TRIUMPH study was previously limited to NYHA Class III and IV patients with PAH receiving stable doses of Tracleer(R) (bosentan) monotherapy.
The FDA has also agreed to an increase in the size of the study from 150 to 200 evaluable patients, and to permit an interim analysis after 150 patients have completed the study. 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. "We hope that the inclusion of Revatio patients in the TRIUMPH study will accelerate enrollment into TRIUMPH, and we're delighted with the opportunity to study inhaled treprostinil on a broader class of patients," said Robert Roscigno, Ph.D., President and Chief Operating Officer of Lung Rx.
TRIUMPH is a 12-week, multi-center, double-blind, randomized, placebo- controlled study of inhaled treprostinil in NYHA Class III and IV patients with severe PAH.
Lung Rx is also pleased to announce the appointment of Eugene Sullivan, M.D. as Chief Medical Officer. Dr. Sullivan is trained in Internal Medicine and Pulmonary/Critical Care Medicine and has spent the past seven years at the FDA in the Division of Pulmonary and Allergy Products, having served for the past two years as Deputy Director. He trained at the University of Colorado Health Sciences Center in Denver, and also was on staff in the Division of Pulmonary and Critical Care Medicine at the Cleveland Clinic. "Dr. Sullivan brings valuable experience to Lung Rx and will be a key contributor to the TRIUMPH study and our other programs," said Dr. Roscigno.
United Therapeutics is a biotechnology company focused on the development and commercialization of unique products for patients with chronic and life- threatening cardiovascular, cancer and infectious diseases.
In addition to historical information, this press release contains forward-looking statements about expectations and intentions regarding the effect of the inclusion of Revatio patients on accelerating enrollment in the TRIUMPH study that are based on United Therapeutics' current beliefs and expectations as to future outcomes. These expectations are subject to risks and uncertainties such as those described in United Therapeutics' periodic reports filed with the Securities and Exchange Commission which may cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in United Therapeutics' periodic reports and documents filed with the Securities and Exchange Commission, including the company's most recent Form 10-K and Form 10-Q. United Therapeutics is providing this information as of June 12, 2006 and undertakes no obligation to publicly update or revise the information contained in this press release whether as a result of new information, future events or any other reason.
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