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NicOx Announces Favorable Blood Pressure Data for Naproxcinod in a Large ABPM Study
Date:11/4/2008

SOPHIA ANTIPOLIS, France, November 4 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced positive top-line results from a 118 patient Ambulatory Blood Pressure Monitoring (ABPM) trial (the 111 study), which compared the 24-hour blood pressure profile of escalating doses of naproxcinod and naproxen in osteoarthritis (OA) patients with controlled hypertension. The primary ABPM parameter was the mean 24-hour ambulatory systolic blood pressure (SBP) measured by ABPM over the whole study period and naproxcinod showed a statistically significant decrease in SBP of 3.8 mmHg (p=0.011) compared to naproxen. Furthermore, in contrast to naproxen, naproxcinod reduced the mean 24-hour SBP and diastolic blood pressure (DBP) from baseline at every dose comparison. Good safety and tolerability were shown by all naproxcinod doses. NicOx plans to provide further details of the results at a leading cardiology conference in 2009.

Naproxcinod is the first investigational drug in the new Cyclooxygenase-Inhibiting Nitric Oxide-Donator (CINOD) class of anti-inflammatory agents, which is nearing the end of phase 3 clinical development for the treatment of the signs and symptoms of osteoarthritis, with the submission of a New Drug Application (NDA) with the US Food and Drug Administration (FDA) projected for mid-2009. NicOx expects to have the results of a second large ABPM study in patients with hypertension and OA (112) before the end of 2008, in addition to the results of the remaining pivotal phase 3 trial in hip OA (303).

COX-2 inhibitors and traditional non-steroidal anti-inflammatory drugs (NSAIDs), such as naproxen and ibuprofen, are widely used as symptomatic treatments for OA. However, they can cause new episodes of high blood pressure and destabilize previously controlled hypertensive patients, which is a particular concern in the OA population where approximately 50% of patients are estimated to be hypertensive.

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