NicOx SA (Euronext Paris: COX) announced today that it completes successfully and in accordance with time limits ads to recruit 417 patients presenting with osteoarthritis and controlled hypertension in two clinical pharmacology studies conducted in the United States. These clinical trials have been developed for evaluating the arterial pressure profile of naproxcinod, compared to that of ibuprofen and naproxen, using Ambulatory Blood Pressure Monitoring (ABP). The results of these studies are expected in the fourth quarter of 2008. Naproxcinod is made to the study NicOx ‘lead and made the first class of anti-inflammatory Cyclooxygenase Inhibitors Nitric Oxide (CINOD). Naproxcinod is currently in Phase 3 clinical development for the treatment of signs and symptoms of osteoarthritis and the results of two recent studies of phase 3 trials are expected in the second half of 2008…

The anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen, are commonly used by osteoarthritis patients to control chronic pain, inflammation and stiffness. However, these products tend to increase blood pressure, an undesirable effect particularly important in patients with osteoarthritis, because of the high prevalence of hypertension and other cardiovascular risk factors among the elderly population.

The objectives of these studies DAFA Phase 1, studies 111 and 112 are designed to provide important additional data on the profile of blood pressure over 24 hours of naproxcinod in chronically treated osteoarthritis patients and for subjects with controlled hypertension, compared with NSAIDs commonly used. The 111 is a study of 12 weeks clinical trial in which 118 patients were recruited in 30 clinical sites to receive increasing doses of either naproxcinod or naproxen at three week intervals. In the study 112, 299 patients were recruited in 60 clinical sites. These patients were randomized to one of five treatment groups to receive for 13 weeks of naproxcinod 375 mg bid (two times a day), naproxcinod 750 mg bid, naproxen 250 mg bid, naproxen 500 mg bid or ibuprofen 600 mg tid (three times a day).



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