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NicOx completes enrolment in second pivotal phase 3 study for naproxcinod and provides development update

17 Dec 2007 - NicOx S.A. announced it has successfully completed the enrolment of 1020 patients in the 302 pivotal phase 3 study for naproxcinod, in-line with projections. Naproxcinod is the Company's lead investigational drug product and the first compound in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class. The 302 study is designed to assess naproxcinod's efficacy for treating the signs and symptoms of osteoarthritis and provide additional blood pressure data, which is a key factor for differentiating naproxcinod from existing anti-inflammatory treatments. Efficacy results from this study are anticipated in the third quarter of 2008.
 
The 302 study represents the largest of the three pivotal phase 3 trials for naproxcinod (the 301, 302 and 303 studies). The 301 study is complete and results were recently presented at the 71st annual meeting of the American College of Rheumatology (ACR), which showed that naproxcinod met all three co-primary efficacy endpoints and demonstrated a similar effect on systolic blood pressure to placebo and a reduction compared to naproxen, a commonly used anti-inflammatory agent. The third and final study (303) is a 13-week trial in patients with osteoarthritis of the hip. Patient enrolment in this trial is well underway, following its initiation in June 2007. Current timelines are that the 303 study should complete enrolment in the second quarter of 2008, with results expected by the end of 2008. NicOx now anticipates the filing of a New Drug Application (NDA) for naproxcinod with the US Food and Drug Administration (FDA) in mid-2009.
 
"The 302 study is the largest and longest duration trial in our program for naproxcinod and our clinical team has proved its effectiveness in successfully recruiting the targeted number of patients in-line with projected timelines", said Pascal Pfister, Chief Scientific Officer of NicOx. "The 302 study will provide 13 and 26-week efficacy results and supportive safety data for the regulatory filing of naproxcinod, in addition to blood pressure data to aid its market differentiation. The completion of patient enrolment in the 303 study is now a top priority and together with the contract research organization for this trial, Covance Inc., we have taken the step of opening additional clinical centers in Europe to accelerate the recruitment in this study."