ICOS-Texas initiate pivotal trial for sitaxsentan

ICOS-Texas Biotechnology, a partnership formed by ICOS and TexasBiotechnology, is recruiting 180 patients for a pivotal Phase II/III STRIDE (Sitaxsentan To Relieve ImpaireD Exercise in pulmonary hypertension) trial to demonstrate the safety and efficacy of sitaxsentan, an oral endothelin A receptor antagonist, as a once-daily treatment for pulmonary arterial hypertension. The primary endpoint is change in exercise capacity over the 12-week study period, and the trial will also evaluate changes in six-minute walk distance, cardiopulmonary hemodynamics and quality of life as secondary endpoints. ICOS-Texas' drug will face competition from others in the same class, including Actelion and Genentech's Tracleer (bosentan) which has recently shown positive results in Phase III clinical trials for the same indication (Marketletter May 7).