NicOx Completes Patient Enrollment In Third Naproxcinod Pivotal Phase 3 Study

Main Category: Arthritis / Rheumatology
Also Included In: Bones / Orthopaedics;  Clinical Trials / Drug Trials
Article Date: 29 May 2008 - 0:00 PDT

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NicOx S.A. (Euronext Paris: COX) announced the completion of patient enrollment in the third pivotal phase 3 clinical trial for naproxcinod, in patients with osteoarthritis of the hip (the 303 study). 810 patients have been randomized in 120 clinical centers in North America and Europe in this study, which is the final phase 3 trial in NicOx' clinical plan for the regulatory filing of naproxcinod. The objective of this study is to assess naproxcinod's efficacy in relieving the signs and symptoms of osteoarthritis of the hip and provide additional safety data, including further information on naproxcinod's blood pressure profile in comparison to another anti-inflammatory medication. Results from this study are expected in Q4 2008 and NicOx projects the filing of a New Drug Application (NDA) in mid-2009.

NicOx is currently in the final stages of developing naproxcinod as an investigational drug for treating the signs and symptoms of osteoarthritis. Naproxcinod is the most advanced compound in a novel class of anti-inflammatory agents known as the Cyclooxygenase-Inhibiting Nitric Oxide Donators (CINODs). The 303 study follows the previous two pivotal phase 3 trials. Successful results were obtained in the 301 phase 3 study, in patients with osteoarthritis of the knee (see press release of October 27, 2006). These data demonstrated superior efficacy to placebo. Data collected suggested that naproxcinod could have no detrimental effect on blood pressure, in contrast to naproxen, a widely used non-steroidal anti-inflammatory drug (NSAID). NSAIDs are known to have the tendency to elevate blood pressure to an extent that may increase the rate of serious cardiovascular adverse events, such as heart attack and stroke.

The 302 study for naproxcinod in patients with osteoarthritis of the knee (see press release of April 3, 2007) is due to report results in Q3 2008.

Maarten Beekman, Vice President of Clinical Development at NicOx, commented: "The completion of patient enrollment in this pivotal phase 3 trial for naproxcinod is a further important step in our plan for the regulatory filing of the first CINOD in the US and Europe. The enrollment of 810 hip osteoarthritis patients in less than a year is a significant achievement, due to the lower availability of these patients for clinical studies and the strict protocol criteria necessary for this study. Medical literature from other anti-inflammatory agents shows that hip osteoarthritis studies have produced a lower rate of positive efficacy results than knee studies. Nevertheless, we believe the stringent criteria applied to the 303 study give us a good probability of achieving a positive result on the primary endpoint."

Trial design and endpoints of the 303 study

The 303 study is a 13-week, double-blind, placebo and naproxen controlled trial in patients with osteoarthritis of the hip. 810 patients have been randomized at 120 clinical centers in the United States, Canada and several European countries. Eligible patients had a diagnosis of primary osteoarthritis of the hip of at least three months in duration and were randomized to three arms: naproxcinod 750 mg bid, placebo bid and naproxen 500 mg bid.

Three co-primary endpoints are being used to compare the efficacy of naproxcinod to placebo, based on the mean change between baseline and week 13 in the following scores: the WOMAC(TM) pain subscale, the WOMAC(TM) function subscale and the subject's overall rating of disease status. These are the standard endpoints used to demonstrate the efficacy of drugs for treating the signs and symptoms of osteoarthritis and the same as those used in the 301 and 302 trials. The 303 study is powered to show statistical significance for the superiority of naproxcinod over placebo at 13 weeks on the three co-primary endpoints. In addition, other variables will be measured in order to assess the general safety and tolerability of naproxcinod.

As in the 301 and 302 studies, patients are undergoing standardized blood pressure measurements at each visit to the clinical center (Office Blood Pressure Measurements, OBPM - see NOTE). NicOx will conduct a predefined statistical analysis on the pooled OBPM data from the phase 3 studies and the results of this analysis are expected in Q4 2008.

NOTE: Office Blood Pressure Measurements (OBPM) are performed by a health care professional during a patient's visit to the clinical center using standard, calibrated equipment (i.e. a sphygmomanometer). OBPM measurements are being performed in the morning and the time between intake of study-drug and measurement of OBPM should be between 2 and 4 hours.

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).

NicOx S.A.
http://www.nicox.com