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NicOx begins third final-phase naproxcinod trial

Fri Jun 29, 2007

NicOx has begun a third final-stage clinical study testing its experimental anti-inflammatory drug naproxcinod in patients with osteoarthritis of the hip, the French biotechnology company said on Friday. NicOx expected the results of this study and an earlier one on patients with osteoarthritis in the knee by mid-2008. NicOx plans to submit naproxcinod for U.S. and European Union marketing approval in the first quarter of 2009.

The company's shares rose as much as 3.2 percent and were up 1 percent at 18.25 euros by 1036 GMT.

About 800 patients at around 100 clinical centres in North America and Europe are expected to take part in the trial that will compare naproxcinod with placebo.

The trial aims to show naproxcinod can relieve the signs and symptoms of osteoarthritis of the hip and to provide additional safety data, mainly confirming it has no detrimental effect on blood pressure compared to current treatments.

Current anti-inflammatory treatments -- non steroidal anti-inflammatory drug (NSAIDs) -- have been linked to higher blood pressure which could lead to heart attacks and strokes.

"NicOx believes that naproxcinod has the potential to become the drug of choice for treating osteoarthritis, based on its unique profile that shows no detrimental effects on blood pressure and a good gastrointestinal tolerability," it said in a statement.

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