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NicOx Initiates Two Large ABPM Studies for Naproxcinod in Hypertensive Patients with Osteoarthritis
Date:3/3/2008

rthritis patients and should add additional weight to the consistent data we are accumulating on naproxcinod's blood pressure profile."

The objectives of these new ABPM studies (see NOTE 2) are to provide important additional data on the 24-hour blood pressure profile of naproxcinod in chronically treated osteoarthritis patients, in comparison to commonly used Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These data should complement the promising results of a 2-week ABPM study for naproxcinod in healthy volunteers with hypertension (the 104 study), which were presented at the American Heart Association (AHA) in November 2007 (see press release of November 7, 2007). They will also complement the Office Blood Pressure Measurements (OBPMs) being collected in each of the pivotal phase 3 osteoarthritis studies (including the completed 301 study and the ongoing 302 and 303 studies -- for full details see the financial results press release issued today).

Design of the 111 and 112 ABPM studies

-- The 111 study is a 12-week, phase 1, double-blind, parallel group,

exploratory trial, where approximately 120 patients will be enrolled

at around 30 clinical sites in the United States. Patients will have a

minimum age of 40 and be diagnosed with controlled essential

hypertension and osteoarthritis, with at least one hip or knee

involved. After a one week screening period, patients will be

randomized to one of two groups, which will receive increasing doses

of either naproxcinod or naproxen at three week intervals. 24-hour

blood pressure monitoring will be conducted at baseline and at the end

of each three-week dose escalation, using an ABPM device (see NOTE 2).

-- The 112 study is a 16-week, phase 1, double-blind, parallel group,

exploratory trial, where approximately 300 patients will be recruited

at around 60 clinical sites in the
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SOURCE NicOx S.A.
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