SOPHIA ANTIPOLIS, France, June 13 /PRNewswire-FirstCall/ --
NicOx S.A. (Euronext Paris: COX) today announced an additional analysis of the blood pressure data from the 301 phase 3 study, showing a statistically significant difference between naproxcinod and naproxen in terms of the mean change from baseline in systolic and diastolic blood pressure at week 13 (p<0.05 for 3 out of 4 comparisons). Commonly used Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as naproxen, have the tendency to raise blood pressure to an extent that may increase the rate of serious cardiovascular adverse events. The new results are being presented today at the 2008 European League Against Rheumatism (EULAR) Congress in Paris. 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.
Positive top-line efficacy results from the 301 study have been previously announced, showing that both doses of naproxcinod (750 mg and 375 mg bid) were superior to placebo on all three co-primary efficacy endpoints (p<0.001). Patients' blood pressure was also measured in the study, with a well defined standardized approach where investigators took office blood pressure measurements (OBPM) at each patient visit to the clinical site. The OBPM changes from baseline at week 13 were predefined safety endpoints of the study and the statistical analysis announced today was conducted on a post hoc basis.
Pascal Pfister MD, Chief Scientific Officer and Head of Research and Development at NicOx, said: "We are very pleased to be presenting these important data from our most advanced CINOD at EULAR. We believe the results of the post hoc statistical analysis on blood pressure are particularly encouraging, as the 301 study was not powered to show a significant difference between naproxcinod and naproxen on this safety endpoint. The fact that significance has been observed in a single trial supports our confidence that a clear statistical differentiation will be obtained between naproxcinod and naproxen in the predefined pooled analysis of the OBPM data."
Two remaining phase 3 trials for naproxcinod are currently ongoing (the 302 and 303 studies) and their results are anticipated in the second half of 2008. Naproxcinod's effect on blood pressure, in comparison to naproxen and placebo, will also be assessed by OBPM in these trials, allowing NicOx to perform a predefined statistical analysis on the pooled OBPM data. NicOx projects the filing of a New Drug Application (NDA) for naproxcinod in mid-2009.
Results of the blood pressure analysis
At week 13, naproxcinod showed mean changes from baseline in systolic blood pressure, compared to naproxen, of minus 2.89 mmHg (p<0.05) for the 750 mg bid dose and -1.82 mmHg (p=0.12) for the 375 mg bid dose. For diastolic blood pressure, in terms of mean changes from baseline compared to naproxen, naproxcinod 750 mg bid was -1.79 mmHg (p<0.05) and naproxcinod 375 mg bid was -1.55 mmHg (p<0.05). At the week 13 time point, more individual patients on naproxcinod showed a decrease in blood pressure compared to patients on placebo and naproxen.
Assessment of efficacy in the trial
The presentation contains additional information on the efficacy outcome measures of the study, going beyond the top-line results announced in 2006 (see press release of October 27, 2006). The detailed results for the two doses of naproxcinod, naproxen and placebo on the WOMAC(TM) pain subscale, WOMAC(TM) function subscale and patients' overall rating of disease status, at 2, 6 and 13 weeks are being displayed in graphical form. The three co-primary endpoints of the study assessed these scores at 13 weeks, in comparison to baseline. Sensitivity and subgroup analyses confirmed the positive result on these co-primary endpoints. Additional efficacy end points, like the Modified Osteoarthritis Research Society International (OARSI) responder rate, a visual analog scale (VAS) of pain intensity during rest or walking and investigators' overall rating of disease status, treatment and response to therapy, also showed positive results.
Study design: 301 was a 13-week, double-blind, placebo and naproxen- controlled trial, in patients with osteoarthritis of the knee. 918 eligible patients were randomized on a 1:1:1:1 basis at 120 clinical sites in the United States to receive: naproxcinod 375 mg bid, naproxcinod 750 mg bid, naproxen 500 mg bid or placebo bid. Eligible patients were at least 40 years old, with a clinical diagnosis of primary osteoarthritis of the knee of at least 3 months duration, confirmed by radiographs, and diagnosed according to the ACR guidelines (patients must have qualified as ACR global functional status I, II or III). There were no statistically significant differences among the four treatment groups for any baseline variables, including hypertension medical history (approximately half of enrolled patients had a medical history of hypertension at baseline).
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is 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).
|SOURCE NicOx S.A.|
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