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NicOx Announces Favorable Blood Pressure Data for Naproxcinod in a Large ABPM Study
Date:11/4/2008

0.011) in favor of naproxcinod.

Michele Garufi, Chairman and CEO of NicOx, commented: "These excellent results are an important addition to the consistent data we are accumulating on naproxcinod's potentially non-detrimental blood pressure profile and its clear differentiation from naproxen. We are confident that naproxcinod's potential will be confirmed by the further clinical results expected in the coming months."

The three doses of naproxcinod showed good general safety and tolerability. In the naproxcinod arm 32 patients (54.2%) experienced one or more adverse events, compared to 38 patients (64.4%) in the naproxen arm. There were no serious adverse events in the naproxcinod arm.

Additional note on study design: The 111 study was a 12-week pharmacodynamic ABPM trial (with 9 weeks of active treatment), with a double-blind, parallel group design, in which 118 OA patients with controlled hypertension were enrolled at 30 clinical sites in the United States. Eligible patients were 40 years and older and had been suffering from osteoarthritis for at least three months, with at least one hip or knee involved. In addition to OA, all patients were diagnosed with controlled essential hypertension (i.e. SBP <140 mmHg and DBP <90 mmHg) and were treated with stable doses of up to two different classes of antihypertensive agents. Patients with uncontrolled hypertension were excluded.

NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) 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
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1. NicOx Announces Second Naproxcinod Pivotal Phase 3 Study (302) Meets Efficacy Primary Endpoints and Supports Non-Detrimental Blood Pressure Effect
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4. NicOx Announces Blood Pressure Analysis From 301 Phase 3 Study for Naproxcinod at EULAR
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