NicOx Completes Enrollment In Second Pivotal Phase 3 Study For Naproxcinod And Provides Development Update

NicOx S.A.
(Eurolist: COX) announced it has successfully completed the
enrollment of 1020 patients in the 302 pivotal phase 3 study for
naproxcinod, in-line with projections. Naproxcinod is the Company's lead
investigational drug product and the first compound in the COX-Inhibiting
Nitric Oxide-Donating (CINOD) class. The 302 study is designed to assess
naproxcinod's efficacy for treating the signs and symptoms of
osteoarthritis and provide additional blood pressure data, which is a key
factor for differentiating naproxcinod from existing anti-inflammatory
treatments. Efficacy results from this study are anticipated in the third
quarter of 2008.


The 302 study represents the largest of the three pivotal phase 3
trials for naproxcinod (the 301, 302 and 303 studies). The 301 study is
complete and results were recently presented at the 71st annual meeting of
the American College of Rheumatology (ACR), which showed that naproxcinod
met all three co-primary efficacy endpoints and demonstrated a similar
effect on systolic blood pressure to placebo and a reduction compared to
naproxen, a commonly used anti-inflammatory agent. The third and final
study (303) is a 13-week trial in patients with osteoarthritis of the hip.
Patient enrollment in this trial is well underway, following its initiation
in June 2007. Current timelines are that the 303 study should complete
enrollment in the second quarter of 2008, with results expected by the end
of 2008. NicOx now anticipates the filing of a New Drug Application (NDA)
for naproxcinod with the US Food and Drug Administration (FDA) in mid-2009.




"The 302 study is the largest and longest duration trial in our program
for naproxcinod and our clinical team has proved its effectiveness in
successfully recruiting the targeted number of patients in-line with
projected timelines," said Pascal Pfister, Chief Scientific Officer of
NicOx. "The 302 study will provide 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 efficacy
of naproxcinod and naproxen at 26 weeks. The general safety and
tolerability of naproxcinod are assessed until week-52 and the trial has a
1-week post-treatment safety period.



Patients' blood pressure is being assessed during each visit to the
treatment center, using controlled Office Blood Pressure Measurements
(OBPM). The blood pressure effect of naproxcinod will be assessed in the
overall population and a sub-group of hypertensive subjects. Various
secondary endpoints will compare the different treatments in terms of the
mean change from baseline in systolic and diastolic blood pressure, at a
range of time points. Additional secondary endpoints will assess the
appearance of new hypertension or worsening of pre-existing hypertension.



NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven
biopharmaceutical company dedicated to the development of nitric
oxide-donating drugs to meet unmet medical needs. NicOx is targeting the
therapeutic areas of inflammation and cardio-metabolic disease. Resources
are focused on two lead compounds, naproxcinod (formerly HCT 3012); in
phase 3 development for the treatment of signs and symptoms of
osteoarthritis, and NCX 4016, in phase 2 for type 2 diabetes.



NicOx has strategic partnerships with some of the world's leading
pharmaceutical companies, including Pfizer Inc and Merck & Co., Inc.



NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a
public company listed on the Eurolist of Euronext(TM) Paris (segment: Next
Economy).



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 SA 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
(amf-france) or on NicOx S.A.'s website
(nicox).


NicOx S.A.

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