SOPHIA ANTIPOLIS, FRANCE--(Marketwire - May 28, 2008) - 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.
