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NicOx' Naproxcinod ABPM Data Presented at American Heart Association
Date:11/7/2007

hieve statistical significance for DBP (p=0.007).

Blood pressure data were collected in the first phase 3 trial for naproxcinod (the 301 study) using Office Blood Pressure Measurements (OBPM) up to 13 weeks (see NOTE 2). The top-line results of this trial revealed a sustained reduction in blood pressure for naproxcinod, compared to baseline and naproxen. Additional results from this phase 3 trial are due to be presented on November 10, 2007, at the 71st annual meeting of the American College of Rheumatology.

"This ABPM trial was the first clinical study focusing specifically on naproxcinod's 24-hour blood pressure profile and its results reveal a clear difference compared to naproxen, which is one of the best-known cardiovascular NSAIDs," said Raymond Townsend, Professor of Medicine at the University of Pennsylvania, Philadelphia, who advised NicOx on the ABPM study. "The medical community recognizes the importance of blood pressure control in reducing the rate of serious cardiovascular events in elderly patients. These data add to the promising blood pressure results obtained by OBPM in the first 13-week phase 3 study and, if supported by the results of the ongoing 302 and 303 phase 3 studies, should contribute to naproxcinod becoming a valuable alternative to selective and non-selective NSAIDs for treating the signs and symptoms of osteoarthritis."

The presentation showed naproxcinod was well tolerated during the study. The number of subjects with at least one treatment related adverse event was low and evenly spread between naproxcinod and naproxen. There were no adverse events suggesting clinically significant hypotensive effects in either group.

Details of study design and ABPM monitoring

The trial was an 8-week, double-blind, randomized, cross-over study in which 131 male and female healthy volunteers were enrolled at 15 US clinical sites to receive either naproxcinod 750 mg bid, followed by naproxen 500 mg bid for 2 weeks, or the
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SOURCE NicOx S.A.
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