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NicOx Completes Enrollment of Two Ambulatory Blood Pressure Measurement (ABPM) Studies for Naproxcinod in Hypertensive OA Patients
Date:7/22/2008

SOPHIA ANTIPOLIS, France, July 22 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced it has successfully completed the enrollment of 417 osteoarthritis (OA) patients with controlled hypertension in two clinical pharmacology studies in the United States, in line with previously announced timelines. These trials are designed to assess the blood pressure profile of naproxcinod, in comparison to ibuprofen and naproxen, using the Ambulatory Blood Pressure Monitoring (ABPM) technique. Results of both studies are expected in Q4 2008. Naproxcinod is NicOx' lead investigational drug and the first compound in the Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents, which is currently in phase 3 clinical development for the treatment of the signs and symptoms of OA, with results of the last two phase 3 studies anticipated in the second half of 2008.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen and naproxen, are commonly used by OA patients to control their chronic pain, inflammation and stiffness. However, these important products have the tendency to raise blood pressure, a side effect of particular concern in OA patients due to the high prevalence of hypertension and other cardiovascular risk factors in this elderly population.

The objectives of these phase 1 ABPM trials, known as the 111 and 112 studies, are to provide important additional data on the 24-hour blood pressure profile of naproxcinod in chronically treated OA patients with controlled hypertension, in comparison to commonly used NSAIDs. The 111 is a 12-week study, which has enrolled 118 patients at 30 clinical sites, who are receiving increasing doses of either naproxcinod or naproxen at three week intervals. The 112 study has enrolled 299 patients at 60 clinical sites, which have been randomized to five groups, receiving 13 weeks of treatment with: naproxcinod 375 mg bid (twice daily), naproxcinod 750 mg bid,
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