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NicOx' Naproxcinod Shows Robust Blood Pressure Results in Phase 3 Pooled Analysis
Date:12/17/2008

SOPHIA ANTIPOLIS, France, December 17 /PRNewswire-FirstCall/ -- NicOx S.A. (NYSE Euronext Paris: COX) today announced positive results of a pre-specified pooled analysis of 2,734 patients with osteoarthritis (OA) from the 301, 302 and 303 pivotal phase 3 studies for naproxcinod. Both doses of naproxcinod showed a significant reduction in systolic and diastolic blood pressure (SBP and DBP) compared to naproxen 500 mg bid over the whole 13 week period (p<0.001 for naproxcinod 750 mg bid and p<0.05 for naproxcinod 375 mg bid). Naproxcinod is the first compound in a novel class of anti-inflammatory agents known as Cyclooxygenase-Inhibiting Nitric Oxide Donators (CINODs).

A significantly lower proportion of patients on naproxcinod experienced an increase in SBP of 5 mmHg or more, compared to naproxen

Over the whole 13 week period the proportion of patients whose SBP increased by 5 mmHg or more was higher for naproxen 500 mg bid, as compared to naproxcinod 750 mg bid (p<0.001), naproxcinod 375 mg bid (p=0.013) and placebo (p<0.001).

Both naproxcinod doses showed a similar blood pressure profile to placebo, in contrast to naproxen which raised SBP (p<0.001)

There is a clear unmet medical need for a novel anti-inflammatory agent with no detrimental impact on blood pressure. COX-2 inhibitors and traditional non-steroidal anti-inflammatory drugs (NSAIDs), such as naproxen, are widely used for the symptomatic treatment of OA but can lead to the onset of new episodes of high blood pressure or worsening of pre-existing hypertension. Both doses of naproxcinod (375 and 750 mg bid) were similar to placebo, as indicated by one-sided 95% confidence intervals (CIs). In contrast, naproxen 500 mg bid raised SBP compared to placebo (p<0.001).

Garret FitzGerald, MD, Professor of Medicine and Pharmacology at the University of Pennsylvania School of Medicine, commented:
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SOURCE NicOx
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