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

office blood pressure measurements (OBPM) with standard equipment (i.e. a mercury sphygmomanometer or aneroid device) during each study visit.

Both doses of naproxcinod were shown to be safe and well tolerated, with 46.7% and 40.8% of patients experiencing at least one adverse event at 750 mg and 375 mg bid, respectively. In the naproxen and placebo bid groups, 56.4% and 38.7% of patients experienced at least one adverse event, respectively. In terms of gastro-intestinal adverse events, the naproxcinod 750 mg and 375 mg bid treatment groups reported event rates of 17.0% and 12.9%, respectively and the naproxen and placebo bid groups reported event rates of 23.6% and 12.2%, respectively. The number of serious adverse events was low and evenly spread among the treatment groups.

"I am very pleased to be presenting these phase 3 data for naproxcinod at the ACR meeting, which is considered to be one of the leading events for the scientific and medical community in rheumatology," declared Thomas J. Schnitzer, MD, PhD, Professor of Medicine at Northwestern University Feinberg School of Medicine, Principal Investigator on the 301 study. "Naproxcinod exerts its therapeutic effect through the well-described inhibition of the cyclo-oxygenase system and a sustained donation of nitric oxide. In this clinical setting, nitric oxide may exert a protective effect in the gastro-intestinal tract and play a homeostatic role in blood pressure control. These phase 3 results suggest that naproxcinod may offer a promising clinical and pharmacological profile for the treatment of the signs and symptoms of osteoarthritis. These findings will need to be confirmed by the ongoing 302 and 303 studies."

Details of the 301 study design and patient characteristics

A total of 918 patients were randomized at 120 clinical sites in the United States to receive either naproxcinod 375 mg bid, naproxcinod 750 mg bid, naproxen 500 mg bid or placebo bid for 13 weeks. Eligible patien
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SOURCE NicOx S.A.
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