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NicOx Provides an Update on the Phase 2a Study for NCX 1000,Conducted With Axcan

SOPHIA ANTIPOLIS, France, May 11, 2007 /PRNewswire-FirstCall/ -- NicOx S.A. (Eurolist: COX) today provided an update on the phase 2a study for NCX 1000, which is covered by its codevelopment agreement with Axcan Pharma Inc. A preliminary analysis of 11 patients from this proof-of-concept study in portal hypertension confirmed the safety profile of NCX 1000 but did not demonstrate the efficacy required to support the continuation of this clinical trial. As a consequence, Axcan and NicOx have agreed not to further pursue the development of NCX 1000 and to terminate the trial.

The trial was a phase 2a, double-blind, dose-escalating proof-of-concept study in which 11 patients with portal hypertension were enrolled in a single clinical center in Spain. Portal hypertension is abnormally raised blood pressure in the portal vein, which carries blood from the digestive system to the liver (see NOTE). Patients were randomized to receive either placebo or escalating doses of NCX 1000 (500mg, 1000mg and 2000mg as the first three doses during the first two days). This was followed by 2000mg (or the maximum tolerated dose) three times a day for the following 14 days.

The primary endpoint of the trial was defined as the comparison between patients' portal pressure in the fasting state on day 16 of treatment with the corresponding baseline values. A secondary endpoint was the same comparison following the consumption of a controlled meal and additional endpoints were based on the response rate (defined in terms of portal pressure reduction), the increase in liver blood flow, clinical safety, tolerability and pharmacokinet ics.

NCX 1000 showed good safety and tolerability, confirming the results observed in two previous phase 1 studies, and NicOx and Axcan will now proceed with further data analysis and full results will be disclosed at a later date.

Maarten Beekman, Vice President of Clinical Devel
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