SOPHIA ANTIPOLIS, France, July 24 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced the top-line results from the 52-week open label safety extension that was conducted following the completion of the 301 phase 3 study for naproxcinod. The results revealed no unexpected safety findings and efficacy was maintained for the one-year duration of the study, as measured by the patients' global assessment scale. In addition, the results showed that the patients' mean blood pressure was stable for 52 weeks following the completion of the 301 study, suggesting that naproxcinod does not increase blood pressure over time. Naproxcinod is NicOx' lead investigational drug and the first compound in the Cyclooxygenase-Inhibiting Nitric Oxide Donator (CINOD) class, which NicOx is developing for the treatment of the signs and symptoms of osteoarthritis.
The 301 safety extension study was conducted in 92 clinical centers in the United States and enrolled the first 500 eligible patients with osteoarthritis of the knee who successfully completed the 301 phase 3 study for naproxcinod (see press releases of June 13, 2008 and November 12, 2007). NicOx expects to announce the top-line efficacy results from the ongoing 302 and 303 pivotal phase 3 studies for naproxcinod in the second half of 2008, ahead of a projected New Drug Application (NDA) in mid-2009.
Pascal Pfister MD, Chief Scientific Officer and Head of Research and Development at NicOx, said: "The data from this open label trial form an important part of our long term safety database for naproxcinod. We are happy with the good overall safety we have observed in this study and look forward to gaining further 52 week data from the 302 study, which includes an active control arm."
The 302 study is being conducted in patients with osteoarthritis of the knee and efficacy is being measured at 13 weeks by the same three co-primary endpoints as in the 301 and 303 studies. In addition, the 302 trial is designed to generate one-year safety data for both doses of naproxcinod, with naproxen 500 mg bid as an active comparator arm.
Design and top-line results of the 301 extension study
The patient population characteristics in the safety extension were similar to the 301 phase 3 trial and were representative of the general osteoarthritis population. Patients who received placebo or naproxen 500 mg bid, during the 13-week active treatment period of the 301 phase 3 study, were randomized to receive either naproxcinod 750 mg or 375 mg bid for a further 52 weeks in the safety extension study. The patients who received naproxcinod 750 mg or 375 mg bid for 13 weeks continued with this same dosing regimen for an additional 52 weeks. The measurements taken at week-13 in the 301 study were used as the baseline for the 301 extension study.
The primary objective of the 301 extension study was to assess the long term safety of naproxcinod, with a particular focus on blood pressure. The results revealed no unexpected safety findings and showed a good overall long term safety for both doses of naproxcinod. Standardized controlled office blood pressure measurements (OBPM) were performed at each patient visit to the clinical site in both the 301 phase 3 study and the 301 safety extension. In the 301 study, naproxcinod showed a sustained reduction in systolic and diastolic blood pressure from baseline, at all time points including at 13 weeks. The data from the safety extension shows that overall the mean systolic and diastolic blood pressures at week 52 were similar compared to the mean values measured in patients starting the extension study, suggesting that both naproxcinod 750 mg and 375 mg bid do not increase blood pressure over time.
A secondary objective of the study was to assess efficacy, as measured by the patient global assessment scale, which revealed that efficacy was maintained until 52 weeks for both doses of naproxcinod.
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) a product-driven biopharmaceutical company dedicated to the development and future commercialization of investigational drugs for unmet medical needs. NicOx is applying its proprietary nitric oxide-donating technology to develop an internal portfolio of New Chemical Entities (NCEs) in the therapeutic areas of inflammatory and cardio-metabolic disease.
Resources are focused on the development of naproxcinod, a proprietary NCE and the first compound in the Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents, which is in phase 3 clinical studies for the treatment of the signs and symptoms of osteoarthritis, with final phase 3 results anticipated in 2008.
Beyond naproxcinod, NicOx has a pipeline containing multiple nitric oxide-donating NCEs, which are in development internally and with partners, including Pfizer Inc and Merck & Co., Inc., for the treatment of prevalent and underserved diseases, such as atherosclerosis, hypertension, glaucoma and Chronic Obstructive Pulmonary Disease (COPD).
NicOx S.A. is headquartered in France and is listed on the Euronext Paris Stock Exchange (Compartment B: Mid Caps).
This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated in the forward-looking statements.
For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of NicOx S.A. to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Document de Reference filed with the AMF, which is available on the AMF website ( http://www.amf-france.org) or on NicOx S.A.'s website (http://www.nicox.com).
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