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NicOx' Naproxcinod Phase 3 Results Presented at American College of Rheumatology
Date:11/12/2007

SOPHIA ANTIPOLIS, France, Nov. 12 /PRNewswire-FirstCall/ -- NicOx S.A. (Eurolist: COX) today announced that results from the first pivotal phase 3 trial for naproxcinod in patients with osteoarthritis of the knee (the 301 study) were presented on November 10, 2007 at the 71st annual meeting of the American College of Rheumatology (ACR), in Boston, Massachusetts (see NOTE). Naproxcinod is NicOx' lead investigational drug product and the first compound in the COX-Inhibiting Nitric Oxide Donator (CINOD) class. The presentation contained additional efficacy data to the top-line results announced in 2006 (see press release of October 27, 2006) which showed that naproxcinod met all three co-primary endpoints of the trial. The data showed that both doses of naproxcinod (750 mg and 375 mg bid) had superior efficacy to placebo at all time points (2, 6 and 13 weeks). This presentation also contained additional safety and tolerability information, including the gastro-intestinal adverse event rates and blood pressure measurements reported for each of the treatment groups.

Detailed clinical data from the 301 study were presented, including data for each of the three co-primary efficacy endpoints: WOMAC(TM) pain subscale, WOMAC(TM) function subscale and patients' overall rating of disease status. Each of the active treatments (naproxcinod 750 mg, naproxcinod 375 mg and naproxen 500 mg bid) were statistically significantly superior to placebo (p<=0.0002) at 2, 6 and 13 weeks. In addition, standard quality of life scores showed a functional improvement for both naproxcinod doses, as well as for the naproxen group.

At week 13, both doses of naproxcinod (750 mg and 375 mg bid) showed a slight decrease in systolic blood pressure in terms of the mean change from baseline compared to placebo (0.8 and 0.2 mmHg, respectively), while a 2 mmHg increase was observed for naproxen compared to placebo. Patients' blood pressure was measured by a health care professional using
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SOURCE NicOx S.A.
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