NicOx SA (Euronext Paris: COX) today announced it has finalized the recruitment of patients in the third clinical study pivotal phase 3 naproxcinod, conducted in patients with osteoarthritis of the hip (the study 303). In this study, 810 patients were randomized in 120 clinical centers in North America and Europe. This is the last study phase 3 clinical program for the regulatory NicOx naproxcinod. The objective of this study is to evaluate the efficacy of naproxcinod to relieve the signs and symptoms of osteoarthritis of the hip and provide additional data about the security of employment, including more information on profile blood pressure naproxcinod compared to that of another anti-inflammatory. The results of this study are expected in the fourth quarter of 2008 and NicOx expects to file the submission of a New Drug Application (NDA) in mid-2009…

NicOx is currently conducting the final stages of development as consisting of naproxcinod to study for the treatment of signs and symptoms of osteoarthritis. Naproxcinod is composed of the most advanced of a new class of anti-inflammatory known as Cyclooxygenase Inhibitors of Nitric Oxide (CINOD). The 303 study follows two studies pivotal Phase 3 precedent. Positive results obtained in the 301 phase 3 study conducted in patients with osteoarthritis of the knee (see press release of October 27, 2006), have demonstrated a superior efficacy compared to placebo. The data collected suggest that naproxcinod could have no adverse effect on blood pressure, in contrast to naproxen, a nonsteroidal anti-inflammatory drugs (NSAIDs) widely used. NSAIDs are known to have a tendency to increase blood pressure point to increase the rate of serious cardiovascular events, such as heart attack and cerebral.



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