NicOx SA (Euronext Paris: COX) today announced the initiation of U.S. clinical pharmacology studies two important, which will assess the blood pressure profile of naproxcinod compared with that of ibuprofen and naproxen with the Use of Ambulatory Blood Pressure Monitoring (ABPM). In total, nearly 420 patients with osteoarthritis and controlled hypertension will be recruited in two separate studies of 12 and 16 weeks each. The results of these studies are expected in the fourth quarter of 2008. Naproxcinod is the compound in NicOx ‘lead investigational and the first class of anti-inflammatory COX inhibitors Nitric Oxide (CINOD), is currently in Phase 3 clinical development for the treatment of signs and symptoms of osteoarthritis with the two previous Phase 3 trials scheduled for the second half of 2008…

Anti-Inflammatory Drugs Non-steroidal drugs (NSAIDs) such as ibuprofen and naproxen, are commonly used to control chronic pain, inflammation and stiffness in patients with osteoarthritis and have significantly improved the quality of life of millions of people. However, these important products tend to increase blood pressure point to increase the rate of serious cardiovascular events (see NOTE 1).

The objectives of these new ABPM studies (see NOTE 2) are to provide important complementary data regarding the blood pressure profile over 24 hours of naproxcinod in patients on chronic osteoarthritis, compared with anti-inflammatory agents No -steroidal (NSAID) commonly used. This data should complement the promising results of a study conducted naproxcinod ABPM for two weeks in healthy volunteers with hypertension (Study 104), which were presented at the American Heart Association ‘(AHA) in November 2007 ( see press release dated November 7, 2007). This data will also be added to the blood pressure measurements in the office (Office Blood Pressure Measurements and OBPM) that are currently collected in each of the pivotal phase 3 OA (including the completed 301 study and the studies 302 and 303 in progress – for details, see the press release relating to financial results released today).



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