SOPHIA ANTIPOLIS, France, July 24 /EMWNews/ -- NicOx S.A.

(Euronext Paris: COX) today announced the top-line results from the 52-week

open label safety extension that was conducted following the completion of

the 301 phase 3 study for naproxcinod. The results revealed no unexpected

safety findings and efficacy was maintained for the one-year duration of

the study, as measured by the patients' global assessment scale. In

addition, the results showed that the patients' mean blood pressure was

stable for 52 weeks following the completion of the 301 study, suggesting

that naproxcinod does not increase blood pressure over time. Naproxcinod is

NicOx' lead investigational drug and the first compound in the

Cyclooxygenase-Inhibiting Nitric Oxide Donator (CINOD) class, which NicOx

is developing for the treatment of the signs and symptoms of

osteoarthritis.



    The 301 safety extension study was conducted in 92 clinical centers in

the United States and enrolled the first 500 eligible patients with

osteoarthritis of the knee who successfully completed the 301 phase 3 study

for naproxcinod (see press releases of June 13, 2008 and November 12,

2007). NicOx expects to announce the top-line efficacy results from the

ongoing 302 and 303 pivotal phase 3 studies for naproxcinod in the second

half of 2008, ahead of a projected New Drug Application (NDA) in mid-2009.



    Pascal Pfister MD, Chief Scientific Officer and Head of Research and

Development at NicOx, said: "The data from this open label trial form an

important part of our long term safety database for naproxcinod. We are

happy with the good overall safety we have observed in this study and look

forward to gaining further 52 week data from the 302 study, which includes

an active control arm."



    The 302 study is being conducted in patients with osteoarthritis of the

knee and efficacy is being measured at 13 weeks by the same three

co-primary endpoints as in the 301 and 303 studies. In addition, the 302

trial is designed to generate one-year safety data for both doses of

naproxcinod, with naproxen 500 mg bid as an active comparator arm.



    Design and top-line results of the 301 extension study



    The patient population characteristics in the safety extension were

similar to the 301 phase 3 trial and were representative of the general

osteoarthritis population. Patients who received placebo or naproxen 500 mg

bid, during the 13-week active treatment period of the 301 phase 3 study,

were randomized to receive either naproxcinod 750 mg or 375 mg bid for a

further 52 weeks in the safety extension study. The patients who received

naproxcinod 750 mg or 375 mg bid for 13 weeks continued with this same

dosing regimen for an additional 52 weeks. The measurements taken at

week-13 in the 301 study were used as the baseline for the 301 extension

study.



    The primary objective of the 301 extension study was to assess the long

term safety of naproxcinod, with a particular focus on blood pressure. The

results revealed no unexpected safety findings and showed a good overall

long term safety for both doses of naproxcinod. Standardized controlled

office blood pressure measurements (OBPM) were performed at each patient

visit to the clinical site in both the 301 phase 3 study and the 301 safety

extension. In the 301 study, naproxcinod showed a sustained reduction in

systolic and diastolic blood pressure from baseline, at all time points

including at 13 weeks. The data from the safety extension shows that

overall the mean systolic and diastolic blood pressures at week 52 were

similar compared to the mean values measured in patients starting the

extension study, suggesting that both naproxcinod 750 mg and 375 mg bid do

not increase blood pressure over time.



    A secondary objective of the study was to assess efficacy, as measured

by the patient global assessment scale, which revealed that efficacy was

maintained until 52 weeks for both doses of naproxcinod.



    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 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-donating NCEs, which are in development internally and with partners,

including Pfizer Inc and Merck & Co., Inc., for the treatment of prevalent

and underserved diseases, such as atherosclerosis, hypertension, glaucoma

and Chronic Obstructive Pulmonary Disease (COPD).



    NicOx S.A. is headquartered in France and is listed on the Euronext

Paris Stock Exchange (Compartment B: Mid Caps).



    This press release contains certain forward-looking statements.

Although the Company believes its expectations are based on reasonable

assumptions, these forward-looking statements are subject to numerous risks

and uncertainties, which could cause actual results to differ materially

from those anticipated in the forward-looking statements.



    For a discussion of risks and uncertainties which could cause actual

results, financial condition, performance or achievements of NicOx S.A. to

differ from those contained in the forward-looking statements, please refer

to the Risk Factors ("Facteurs de Risque") section of the Document de

Reference filed with the AMF, which is available on the AMF website (

http://www.amf-france.org) or on NicOx S.A.'s website

(http://www.nicox.com).



    http://www.nicox.com