SOPHIA ANTIPOLIS, France, July 22 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced it has successfully completed the enrollment of 417 osteoarthritis (OA) patients with controlled hypertension in two clinical pharmacology studies in the United States, in line with previously announced timelines. These trials are designed to assess the blood pressure profile of naproxcinod, in comparison to ibuprofen and naproxen, using the Ambulatory Blood Pressure Monitoring (ABPM) technique. Results of both studies are expected in Q4 2008. Naproxcinod is NicOx' lead investigational drug and the first compound in the Cyclooxygenase-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 OA, 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 OA patients to control their chronic pain, inflammation and stiffness. However, these important products have the tendency to raise blood pressure, a side effect of particular concern in OA patients due to the high prevalence of hypertension and other cardiovascular risk factors in this elderly population.
The objectives of these phase 1 ABPM trials, known as the 111 and 112 studies, are to provide important additional data on the 24-hour blood pressure profile of naproxcinod in chronically treated OA patients with controlled hypertension, in comparison to commonly used NSAIDs. The 111 is a 12-week study, which has enrolled 118 patients at 30 clinical sites, who are receiving increasing doses of either naproxcinod or naproxen at three week intervals. The 112 study has enrolled 299 patients at 60 clinical sites, which have been randomized to five groups, receiving 13 weeks of treatment with: naproxcinod 375 mg bid (twice daily), naproxcinod 750 mg bid, naproxen 250 mg bid, naproxen 500 mg bid or ibuprofen 600 mg tid (three times daily).
The data from the 111 and 112 studies will complement the results of a 2-week ABPM study with naproxcinod compared to naproxen in hypertensive volunteers (the 104 study), which were presented at the American Heart Association (AHA) in November 2007. They will also complement the Office Blood Pressure Measurements (OBPMs) being collected in each of the pivotal phase 3 OA studies (including the completed 301 study and the ongoing 302 and 303 studies).
Maarten Beekman, Vice President of Clinical Development and Medical Affairs at NicOx commented: "We are very pleased to have fully enrolled these two clinical pharmacology studies and we look forward to their results in the fourth quarter of this year. We believe the timely achievement of this milestone is a testament to the strength of the clinical team we have assembled at NicOx and also reflects the interest of clinical centers and patients in 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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