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NicOx Announces Blood Pressure Analysis From 301 Phase 3 Study for Naproxcinod at EULAR
Date:6/13/2008

acy end points, like the Modified Osteoarthritis Research Society International (OARSI) responder rate, a visual analog scale (VAS) of pain intensity during rest or walking and investigators' overall rating of disease status, treatment and response to therapy, also showed positive results.

Study design: 301 was a 13-week, double-blind, placebo and naproxen- controlled trial, in patients with osteoarthritis of the knee. 918 eligible patients were randomized on a 1:1:1:1 basis at 120 clinical sites in the United States to receive: naproxcinod 375 mg bid, naproxcinod 750 mg bid, naproxen 500 mg bid or placebo bid. Eligible patients were at least 40 years old, with a clinical diagnosis of primary osteoarthritis of the knee of at least 3 months duration, confirmed by radiographs, and diagnosed according to the ACR guidelines (patients must have qualified as ACR global functional status I, II or III). There were no statistically significant differences among the four treatment groups for any baseline variables, including hypertension medical history (approximately half of enrolled patients had a medical history of hypertension at baseline).

NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven biopharmaceutical company dedicated to the development and future commercialization of investigational drugs for unmet medical needs. NicOx is applying its proprietary nitric oxide-donating technology to develop an internal portfolio of New Chemical Entities (NCEs) in the therapeutic areas of inflammatory and cardio-metabolic disease.

Resources are focused on the development of naproxcinod, a proprietary NCE and the first compound in the Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents, which is in phase 3 clinical studies for the treatment of the signs and symptoms of osteoarthritis, with final phase 3 results anticipated in 2008.

Beyond naproxcinod, NicOx has a pipeline containing multiple nitric oxide-
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SOURCE NicOx S.A.
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