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NicOx Initiates Second Phase 3 Study to Confirm Naproxcinod's Efficacy and Improved Blood Pressure Profile
France, April 3 /PRNewswire
NicOx S.A. (Eurolist: COX) today announced that it has initiated the second pivotal phase 3 trial for naproxcinod in patients with osteoarthritis of the knee (the 302 study). The trial is expected to enroll approximately 1020 patients at around 120 clinical centers in the United States. The objective of the study is to confirm naproxcinod's efficacy and provide additional blood pressure data, a key factor to differentiate naproxcinod from existing treatments. Efficacy results are expected in mid-2008.
Michele Garufi, Chairman and CEO of NicOx, declared: "The initiation of this second pivotal phase 3 trial is in line with our development plan for naproxcinod, which foresees the filing of a New Drug Application in the US during the first quarter of 2009. Based upon the recent positive results from the first phase 3 trial and from the ABPM trial, we at NicOx continue to dedicate our resources to proving that naproxcinod is an innovative and unique drug for the treatment of the signs and symptoms of osteoarthritis. Naproxcinod represents the driving force for NicOx' transformation into an integrated pharmaceutical company."
Naproxcinod is the first compound in the COX-Inhibiting Nitric Oxide- Donating (CINOD) class, which NicOx aims to develop as the drug-of-choice for treating the signs and symptoms of osteoarthritis. The initiation of 302 follows the successful results obtained for naproxcinod in previous phase 2 and phase 3 trials (see press releases of October 27, 2006, and December 20, 2005), which showed superior efficacy to placebo and no detrimental effect on blood pressure, when compared to existing non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs represent an established symptomatic treatment for the millions of patients who suffer from osteoarthritis. However, these widely used products are associated with worrying side effects, including the tendency to raise blood pressure to an extent that may increase the rate of cardiovascular adverse events.
Design and endpoints of the 302 study
The 302 study is a 53-week, randomized, double-blind, efficacy and safety trial in patients with osteoarthritis of the knee. Eligible patients will be randomized to one of the following treatment groups: naproxcinod 375 mg bid (52 weeks), naproxcinod 750 mg bid (52 weeks), naproxen 500 mg bid (52 weeks) and placebo bid during the first 13 weeks. After 13 weeks, the placebo treated patients will be randomized to either naproxcinod 375 mg bid or naproxcinod 750 mg bid for the remainder of the trial (39 weeks).
Eligible patients should have primary osteoarthritis of the knee of at least 3 months duration. The trial will recruit both hypertensive and non- hypertensive patients, although patients with uncontrolled hypertension will be excluded.
The two doses of naproxcinod will be compared to placebo on three co- primary efficacy endpoints, 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 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 are the same as those used in the 301 study.
A secondary endpoint of the trial will compare the efficacy of naproxcinod and naproxen at 26 weeks. The general safety and tolerability of naproxcinod will be assessed until week-52 and the trial will have a 1-week post-treatment safety period.
Blood pressure monitoring and endpoints
As in the 301 study, patients' blood pressure will be assessed during each visit to the treatment center, using controlled Office Blood Pressure Measurements (OBPM - see NOTE). The blood pressure effect of naproxcinod will be assessed in two groups of patients: the overall population and a sub-group of hypertensive subjects. Various blood pressure endpoints will compare the different treatments in terms of the mean change from baseline in systolic and diastolic blood pressure, at a range of time points. Additional blood pressure endpoints will assess the appearance of new hypertension or worsening of pre- existing hypertension.
NicOx plans to initiate a third phase 3 trial (the 303 study) in the first half of 2007, which will assess naproxcinod's efficacy and safety in patients with osteoarthritis of the hip. In addition, the Company will conduct a predefined statistical analysis on the pooled OBPM data from the three phase 3 studies (301, 302 and 303).
Staffan Stromberg, Vice President of Drug Development at NicOx and Project Team Leader for naproxcinod, added: "Based on phase 2 and 3 data, we are very confident about the safety and efficacy profile of naproxcinod. This second phase 3 study will provide additional safety and efficacy data for regulatory filing, as well as giving us the opportunity to statistically test naproxcinod's improved blood pressure profile, by pooling its data with the other phase 3 trials. Reducing the cardiovascular risk of NSAID users is very important and we believe that the potentially improved blood pressure profile of naproxcinod will be a key differentiating factor in the anti-inflammatory drug market."
NOTE: Office Blood Pressure Measurements (OBPM) are made by a health care professional during a patient's visit to the treatment center using standard equipment (i.e. a sphygmomanometer). OBPM will be performed in the morning and the time between intake of study-drug and measurement of OBPM should be between 2 and 4 hours. Systolic blood pressure is the maximum pressure in the arteries when the heart is contracting, while diastolic pressure is the lowest pressure between heart beats.
NicOx (Bloomberg : COX : FP, Reuters : NCOX.PA) is a product-driven biopharmaceutical company dedicated to the development of nitric oxide- donating drugs to meet unmet medical needs. NicOx is targeting the therapeutic areas of pain and inflammation and cardio-metabolic disease. Resources are focused on two lead compounds, naproxcinod (formerly HCT 3012); in phase 3 development for the treatment of signs and symptoms of osteoarthritis, and NCX 4016, in phase 2 for type 2 diabetes.
NicOx has strategic partnerships with some of the world's leading pharmaceutical companies, including Pfizer Inc and Merck & Co., Inc.
NicOx S.A. is headquartered in Sophia-Antipolis, France, and is listed on the Eurolist of Euronext(TM) Paris (segment: Next Economy).
The elements included in this communication may contain forward-looking statements subject to certain risks and uncertainties. Actual results of the company may differ materially from those indicated in the forward-looking statements because of different risks factors described in the company's document de reference.
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