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NicOx Announces Blood Pressure Analysis From 301 Phase 3 Study for Naproxcinod at EULAR
Date:6/13/2008

SOPHIA ANTIPOLIS, France, June 13 /PRNewswire-FirstCall/ --

NicOx S.A. (Euronext Paris: COX) today announced an additional analysis of the blood pressure data from the 301 phase 3 study, showing a statistically significant difference between naproxcinod and naproxen in terms of the mean change from baseline in systolic and diastolic blood pressure at week 13 (p<0.05 for 3 out of 4 comparisons). Commonly used Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as naproxen, have the tendency to raise blood pressure to an extent that may increase the rate of serious cardiovascular adverse events. The new results are being presented today at the 2008 European League Against Rheumatism (EULAR) Congress in Paris. Naproxcinod is NicOx' lead investigational drug and the first compound in the Cyclooxygenase-Inhibiting Nitric Oxide Donator (CINOD) class, which NicOx is developing for the treatment of the signs and symptoms of osteoarthritis.

Positive top-line efficacy results from the 301 study have been previously announced, showing that both doses of naproxcinod (750 mg and 375 mg bid) were superior to placebo on all three co-primary efficacy endpoints (p<0.001). Patients' blood pressure was also measured in the study, with a well defined standardized approach where investigators took office blood pressure measurements (OBPM) at each patient visit to the clinical site. The OBPM changes from baseline at week 13 were predefined safety endpoints of the study and the statistical analysis announced today was conducted on a post hoc basis.

Pascal Pfister MD, Chief Scientific Officer and Head of Research and Development at NicOx, said: "We are very pleased to be presenting these important data from our most advanced CINOD at EULAR. We believe the results of the post hoc statistical analysis on blood pressure are particularly encouraging, as the 301 study was not powered to show a significant difference between naproxcinod and naproxen on this safety en
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SOURCE NicOx S.A.
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