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NicOx Announces Top-Line Results From Naproxcinod 52-Week 301 Safety Extension
Date:7/24/2008

SOPHIA ANTIPOLIS, France, July 24 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced the top-line results from the 52-week open label safety extension that was conducted following the completion of the 301 phase 3 study for naproxcinod. The results revealed no unexpected safety findings and efficacy was maintained for the one-year duration of the study, as measured by the patients' global assessment scale. In addition, the results showed that the patients' mean blood pressure was stable for 52 weeks following the completion of the 301 study, suggesting that naproxcinod does not increase blood pressure over time. 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.

The 301 safety extension study was conducted in 92 clinical centers in the United States and enrolled the first 500 eligible patients with osteoarthritis of the knee who successfully completed the 301 phase 3 study for naproxcinod (see press releases of June 13, 2008 and November 12, 2007). NicOx expects to announce the top-line efficacy results from the ongoing 302 and 303 pivotal phase 3 studies for naproxcinod in the second half of 2008, ahead of a projected New Drug Application (NDA) in mid-2009.

Pascal Pfister MD, Chief Scientific Officer and Head of Research and Development at NicOx, said: "The data from this open label trial form an important part of our long term safety database for naproxcinod. We are happy with the good overall safety we have observed in this study and look forward to gaining further 52 week data from the 302 study, which includes an active control arm."

The 302 study is being conducted in patients with osteoarthritis of the knee and efficacy is being measured at 13 weeks by the same three co-primary endpoints as in the 301 and 303 studies. In addition, th
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