SOPHIA ANTIPOLIS, France, March 3 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced the initiation of two large clinical pharmacology studies in the United States, which will assess the blood pressure profile of naproxcinod in comparison to ibuprofen and naproxen, using the Ambulatory Blood Pressure Monitoring (ABPM) technique. These separate studies, 12 and 16 weeks in duration, will together recruit a total of around 420 osteoarthritis patients with controlled hypertension and results are projected in Q4 2008. Naproxcinod is NicOx' lead investigational drug and the first compound in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents, which is currently in phase 3 clinical development for the treatment of the signs and symptoms of osteoarthritis, with results of the last two phase 3 studies anticipated in the second half of 2008.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen and naproxen, are commonly used by osteoarthritis patients to control their chronic pain, inflammation and stiffness and significantly improve quality of life for millions of people. However, these important products have the tendency to raise blood pressure to an extent that may increase the rate of serious cardiovascular adverse events (see NOTE 1).
Pascal Pfister MD, Chief Scientific Officer and Head of Research and
Development at NicOx, said: "Our development program for naproxcinod aims
to address the safety concerns surrounding anti-inflammatory agents and
blood pressure, which represents a serious medical issue. Previous studies
using the ABPM technique and Office Blood Pressure Measurements have
suggested that naproxcinod may have an improved blood pressure profile
compared to existing anti-inflammatory drugs, which would greatly
facilitate its future adoption by physicians and patients. These two new
studies will provide important data in a relevant population of chronically
|SOURCE NicOx S.A.|
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