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NicOx Completes Enrollment in Second Pivotal Phase 3 Study for Naproxcinod and Provides Development Update
Date:12/14/2007

rovide 13 and 26-week efficacy results and supportive safety data for the regulatory filing of naproxcinod, in addition to blood pressure data to aid its market differentiation. The completion of patient enrollment in the 303 study is now a top priority and together with the contract research organization for this trial, Covance Inc., we have taken the step of opening additional clinical centers in Europe to accelerate the recruitment in this study."

302 study design

The 302 study for naproxcinod was initiated in April, 2007 and is being conducted by Premier Research Group plc. This study is a 53-week, randomized, double-blind, efficacy and safety trial in which 1020 patients with osteoarthritis of the knee have been enrolled at 150 clinical sites throughout the United States. Patients have been randomized to one of the following treatment groups: naproxcinod 375 mg bid (52 weeks), naproxcinod 750 mg bid (52 weeks), naproxen 500 mg bid (52 weeks) and placebo bid during the first 13 weeks. After 13 weeks, the placebo treated patients are being randomized to either naproxcinod 375 mg bid or naproxcinod 750 mg bid for the remainder of the trial (39 weeks). Patients have primary osteoarthritis of the knee of at least 3 months duration. The trial has recruited both hypertensive and non-hypertensive patients, although patients with uncontrolled hypertension have been excluded.

The two doses of naproxcinod (750 mg and 375 mg bid) will be compared to placebo on three co-primary efficacy endpoints, based on the mean change between baseline and week-13 in the following scores: the WOMAC(TM) pain subscale, the WOMAC(TM) function subscale and subject's overall rating of disease status. These are the standard endpoints used to demonstrate the efficacy of drugs for treating the signs and symptoms of osteoarthritis and are the same as those used in the other two pivotal phase 3 studies for naproxcinod. A secondary endpoint of the trial is to compare the effica
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SOURCE NicOx S.A.
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