NicOx Announces U.S. Phase 2a Results for PF-03187207 and Gives an Update on Continuing NO-prostagland...(ension in one or both eyes.Patients were...),Health

Date:5/6/2008

ension, in one or both eyes. Patients were randomized to receive 28 days of treatment with either morning or evening doses of Xalatan(R) 0.005%, or various doses of PF-03187207 (five different doses of PF-03187207 were tested, some of which were tested with both morning or evening dosing arms). Patients' IOP was measured at 8am, 10am, 1pm and 4pm, at baseline and on days 7, 14, 21 and 28.

The primary objective of the study was to determine if any PF-03187207 dose was superior to Xalatan(R) 0.005% for the reduction of elevated diurnal IOP (mean over the day, based on the values obtained at 8am, 10am, 1pm and 4pm) and the primary endpoint compared the two treatments in terms of the change in mean IOP from baseline at day 28. On this primary endpoint, evening administration of the highest dose of PF-03187207 showed a 12% (approximately 1 mmHg) greater reduction in diurnal IOP than evening administration of Xalatan(R) 0.005%, although this difference did not reach statistical significance.

On a secondary endpoint of the study (IOP lowering from baseline at 4pm, as an average across all study visits), evening administration of PF-03187207 was statistically significantly better than evening dosing of Xalatan(R) 0.005% by 22%, which was approximately 1.4 mmHg in absolute terms (p<0.05). This difference occurred approximately 20 hours after study drug administration, suggesting a potential clinical advantage for PF-03187207.

Maarten Beekman, Vice President of Clinical Development at NicOx, commented: "The advantage of the highest dose of PF-03187207 over Xalatan(R) was consistent over all time points and all study visits, as well as with morning and evening dosing comparisons, giving us strong confidence in these results. Furthermore, the significant difference observed at the 4pm time point is particularly interesting, as it suggests nitric oxide donation from PF-03187207 delivers a more sustained IOP lowering effect compared to Xalatan(R). The additio
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SOURCE NicOx S.A. Copyright©2008 PR Newswire. All rights reserved

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