Results Of Inhaled Treprostinil Controlled Pilot Studies Reported In The Journal Of The American College Of Cardiology

Main Category: Cardiovascular / Cardiology
Also Included In: Hypertension;  Respiratory / Asthma;  Clinical Trials / Drug Trials
Article Date: 09 Feb 2007 - 0:00 PDT

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Lung Rx, Inc., a wholly owned subsidiary of United Therapeutics Corporation (Nasdaq: UTHR), announced publication in The Journal of The American College of Cardiology (JACC) of the results of the randomized, controlled pilot studies of Treprostinil Sodium for Inhalation, an investigational compound being developed by Lung Rx for the treatment of severe pulmonary arterial hypertension. Lung Rx also announced today that the name VIVETA has been submitted to the FDA as the proposed brand name for Treprostinil Sodium for Inhalation.

The JACC article concluded that dose increases of VIVETA across a ten-fold range were "effective and well-tolerated" and that the medicine "may offer a new strategy for the treatment of pulmonary arterial hypertension."

"I am honored to salute Drs. Rubin and Seeger, the co-chairs of the steering committee for these pioneering pilot studies," said Martine Rothblatt, Ph.D., Chairman and CEO of Lung Rx. "They have clearly moved pulmonary science forward by demonstrating the unique pulmonary selectivity of the VIVETA molecule."

The JACC publication, entitled "Favorable Effects of Inhaled Treprostinil in Severe Pulmonary Hypertension: Results From Randomized Controlled Pilot Studies," reports on the results of right heart catheterizations performed on 123 patients across three separate clinical trials. Right heart catheterizations are the gold standard for determining whether a medicine is reducing the life-threatening heart-lung pressures that are the hallmark of pulmonary arterial hypertension. The studies demonstrated, with a p-value < 0.0001, that VIVETA was more effective than a comparator molecule (iloprost) in producing a sustained reduction in pulmonary pressures. This means that there was a less than a one in ten thousand chance that these results were spurious. The authors observed that inhaled treprostinil "exerts sustained pulmonary vasodilation with excellent tolerability at relatively low doses and may be inhaled in a few breaths." (J Am Coll Cardiol 2006; 48:8, pp.1672-81).

Lung Rx is in the process of completing its confirmatory TRIUMPH-1 (TReprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension) study, a 12-week, double-blind, randomized, placebo-controlled study of VIVETA in NYHA Class III and IV patients with severe pulmonary arterial hypertension that is being conducted at centers in the United States and Europe.

Lung Rx, headquartered in Satellite Beach, Florida, is a wholly owned subsidiary of United Therapeutics Corporation focused on medicines that treat or are delivered via the lungs. 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.

United Therapeutics Corporation
http://www.unither.com/

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