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NicOx Completes Patient Enrollment in Third Naproxcinod Pivotal Phase 3 Study
Date:5/28/2008

SOPHIA ANTIPOLIS, France, May 28 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced the completion of patient enrollment in the third pivotal phase 3 clinical trial for naproxcinod, in patients with osteoarthritis of the hip (the 303 study). 810 patients have been randomized in 120 clinical centers in North America and Europe in this study, which is the final phase 3 trial in NicOx' clinical plan for the regulatory filing of naproxcinod. The objective of this study is to assess naproxcinod's efficacy in relieving the signs and symptoms of osteoarthritis of the hip and provide additional safety data, including further information on naproxcinod's blood pressure profile in comparison to another anti-inflammatory medication. Results from this study are expected in Q4 2008 and NicOx projects the filing of a New Drug Application (NDA) in mid-2009.

NicOx is currently in the final stages of developing naproxcinod as an investigational drug for treating the signs and symptoms of osteoarthritis. Naproxcinod is the most advanced compound in a novel class of anti-inflammatory agents known as the Cyclooxygenase-Inhibiting Nitric Oxide Donators (CINODs). The 303 study follows the previous two pivotal phase 3 trials. Successful results were obtained in the 301 phase 3 study, in patients with osteoarthritis of the knee (see press release of October 27, 2006). These data demonstrated superior efficacy to placebo. Data collected suggested that naproxcinod could have no detrimental effect on blood pressure, in contrast to naproxen, a widely used non-steroidal anti-inflammatory drug (NSAID). NSAIDs are known to have the tendency to elevate blood pressure to an extent that may increase the rate of serious cardiovascular adverse events, such as heart attack and stroke.

The 302 study for naproxcinod in patients with osteoarthritis of the knee (see press release of April 3, 2007) is due to report results in Q3 2008.

Maarten Beekman, Vice
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SOURCE NicOx S.A.
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