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NicOx Announces Second Naproxcinod Pivotal Phase 3 Study (302) Meets Efficacy Primary Endpoints and Supports Non-Detrimental Blood Pressure Effect
Date:9/15/2008

PARIS, September 15 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced successful top-line results from the second phase 3 study for naproxcinod in 1020 patients with osteoarthritis of the knee (the 302 study). Both doses of naproxcinod (750 mg and 375 mg bid) met the three co-primary efficacy endpoints at week-13 (p<0.001). The study also comfortably met the main secondary endpoint, demonstrating that naproxcinod 750 mg bid was statistically non-inferior to naproxen 500 mg bid on the WOMAC(TM) pain and function subscales at week-13 and 26. Naproxcinod is the first compound in the new Cyclooxygenase-Inhibiting Nitric Oxide-Donator (CINOD) class of anti-inflammatory agents, which NicOx is developing as a drug for the treatment of the signs and symptoms of osteoarthritis.

NicOx' phase 3 clinical program for naproxcinod consists of three pivotal trials (including the previously completed 301 study in osteoarthritis of the knee and the ongoing 303 study in osteoarthritis of the hip, in addition to the 302 study). Overall, the results of the 302 study support naproxcinod's non-detrimental effect on blood pressure and are consistent with those observed in the 301 study, with naproxcinod 750 mg bid showing a numerical reduction in systolic and diastolic blood pressure at week-13 and 26, compared to baseline and naproxen 500 mg bid. Existing non-steroidal anti-inflammatory agents (NSAIDs) such as ibuprofen and naproxen have the tendency to raise blood pressure, which is a side effect of particular concern in the osteoarthritis population.

A post hoc pooled analysis of the blood pressure data from the 301 and 302 studies showed a statistically significant reduction for naproxcinod 750 mg bid, compared to naproxen 500 mg bid, in terms of the mean change from baseline at week-13, of 2.3 mmHg (p=0.004) for systolic blood pressure and 1.1 mmHg (p=0.034) for diastolic blood pressure. In the planning of the phase 3 program, NicOx had fo
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4. NicOx Completes Patient Enrollment in Third Naproxcinod Pivotal Phase 3 Study
5. NicOx Announces Initiation of First Phase 1 Study of Investigational Nitric Oxide-Donating Agent in Hypertensive Patients by Merck & Co., Inc.
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