SOPHIA ANTIPOLIS, France, October 22 /PRNewswire-FirstCall/ -- NicOx
S.A. (Euronext Paris: COX) today reported financial results for the nine
months ended September 30, 2008.
Key highlights of the third quarter of 2008:
- Positive top-line results from the 302 study for naproxcinod. The study
met all three co-primary efficacy endpoints at week-13 (p<0.001) and
naproxcinod 750 mg bid comfortably met the main secondary endpoint of
non-inferiority to naproxen 500 mg bid at week-13 and 26. Blood
pressure data from the 302 study also supported naproxcinod's non-
detrimental effect on blood pressure.
- Good overall long term safety demonstrated for both doses of
naproxcinod in the 301 extension study, with no unexpected safety
findings. In addition, the patients' mean blood pressure remained
stable for the 52 weeks following the completion of the 301 study,
suggesting that naproxcinod does not increase blood pressure over time.
- Exclusive agreement signed with Capsugel, the leading
producer of two-piece capsules, for the commercial manufacture of
naproxcinod capsules. Capsugel will be responsible for the formulation
and encapsulation of naproxcinod API.
- Enrollment of 417 osteoarthritis patients with controlled
hypertension successfully completed in two Ambulatory Blood Pressure
Monitoring (ABPM) trials, the 111 and 112 studies. These trials are
designed to assess the 24-hour blood pressure profile of naproxcinod,
in comparison to ibuprofen and naproxen.
- PF-03187207 demonstrated an improvement over Xalatan(R) 0.005% in a
Japanese phase 2 study in glaucoma, although the primary endpoint
at day 28 was not met. NicOx is currently discussing the rights to
PF-03187207 with Pfizer to allow its potential continued development
and commercialization, following Pfi
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