Financial Results for Full Year 2007: NicOx Significantly Advances Clinica... (rogress in the pivotal phase 3 program f...)

Financial Results for Full Year 2007: NicOx Significantly Advances Clinical Programs

Date:3/3/2008

rogress in the pivotal phase 3 program for naproxcinod

NicOx is developing naproxcinod in phase 3 clinical studies, which are designed to demonstrate that it is safe, well tolerated and effective for treating the signs and symptoms of osteoarthritis, in addition to having no detrimental effect on blood pressure, in contrast to existing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

The phase 3 efficacy program consists of 3 pivotal studies, which are being conducted for regulatory submissions in the U.S. and Europe:

-- The 301 study was conducted in patients with osteoarthritis of the knee

and has provided successful efficacy and blood pressure results which

were presented at the American College of Rheumatology (ACR) in

November 2007. A 52-week open-label safety extension of this study has

now been completed and data are currently being analyzed

-- The 302 study started enrolling patients with osteoarthritis of the

knee in the U.S. in April 2007 and the enrollment of 1020 patients was

successfully completed in December 2007. 26-week efficacy and safety

results are anticipated in the third quarter of 2008

-- The 303 study was initiated in June 2007 in the U.S. and Europe, in

patients with osteoarthritis of the hip. This study is expected to

complete enrollment in the second quarter of 2008 and 13-week efficacy

and safety results are anticipated in 4Q'08

As in the 301 study, patients in the ongoing 302 and 303 studies are undergoing controlled, standardized Office Blood Pressure Measurements (OBPM) at each visit to the treatment center. Following the completion of the phase 3 program, NicOx plans to perform a predefined statistical analysis on the pooled OBPM data from the phase 3 studies, which should be complete in the fourth quarter of 2008. NicOx projects the submission of a New Drug Application (NDA) for naproxcinod to the U
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Financial Results for Full Year 2007: NicOx Significantly Advances Clinica...(rogress in the pivotal phase 3 program f...),Health