SOPHIA ANTIPOLIS, France, Aug. 3 /PRNewswire-FirstCall/ -- NicOx S.A. (Eurolist: NICOX) today announced that it has successfully completed subject enrolment in the ambulatory blood pressure monitoring (ABPM) trial for naproxcinod (HCT 3012). The randomization of 120 volunteer subjects with stable essential hypertension at 16 clinical centers in the United States was initiated in May this year and has been completed ahead of schedule. Results are anticipated in the fourth quarter of 2006. Naproxcinod is a novel, proprietary, first in class COX-inhibiting nitric oxide-donator (CINOD), which is currently in phase 3 clinical development for the treatment of the signs and symptoms of osteoarthritis.
Non steroidal anti-inflammatory drugs (NSAIDs) represent the only established symptomatic treatment for the millions of patients who suffer from osteoarthritis worldwide. However, NSAIDs are known to raise blood pressure and antagonize the blood pressure lowering effect of antihypertensive medications to an extent that may contribute to an increased incidence of cardiovascular events. NicOx aims to develop naproxcinod as the drug-of-choice for the treatment of osteoarthritis, especially in those patients with co-existing hypertension, based on nitric oxide’s ability to improve blood pressure control.
“This trial in hypertensive subjects is an important element of our plan to demonstrate a differentiated blood pressure profile for naproxcinod compared to existing anti-inflammatory agents, as it will help us to characterize naproxcinod’s behavior in subjects with existing high blood pressure,” commented Staffan Stromberg, Vice President of Drug Development at NicOx. “Beyond this, we see naproxcinod being an important treatment option for the whole osteoarthritis population, due to the propensity of NSAIDs to also trigger the onset of high blood pressure in patients with no previous history of hypertension and the high cardiovascular risk that applies generally to the elderly osteoarthritis population.”
The ABPM study employs an automatic mobile device to record blood pressure at regular intervals over 24 hours and has enrolled only otherwise healthy, hypertensive subjects. These subjects do not have osteoarthritis but are between the age of 50 and 75 so as to be representative of the osteoarthritis population. The trial has a double-blind, randomized, cross-over design, and subjects have been randomized to either one of two groups: approximately 60 are being treated with 750 mg of naproxcinod, twice-daily, for 14-days, followed by 500 mg of naproxen, twice-daily, for 14 days and around a further 60 subjects are receiving the compounds in the opposite order. Blood pressure measurements are being collected using the ABPM device.
The primary endpoint of the trial is the mean change from baseline for each active treatment period in the average 24 hour systolic blood pressure (SBP) recorded during a 24 hour ABPM. A number of secondary endpoints will follow a variety of additional blood pressure parameters, including diastolic blood pressure (DBP) and blood pressure values recorded during the day and night. The trial will also evaluate the general safety and tolerability of naproxcinod, compared to naproxen.
Maarten Beekman, Vice President of Clinical Development at NicOx commented: “It can be challenging to meet enrolment timelines in clinical trials using 24-hour ambulatory blood pressure monitoring in volunteer subjects, due to the burden that it may bring to the subjects, for example potential sleep disruption. We believe the early completion of enrolment reflects the interest of clinical centers in naproxcinod and is a testament to the strength of the clinical team we have assembled at NicOx and our efficient collaboration with PRA International.”
This ABPM trial is expected to provide important complementary blood pressure data to those being collected in the ongoing phase 3 study in osteoarthritis patients, both hypertensive and normotensive, which also completed enrolment ahead of schedule in May 2006. The phase 3 program is designed to demonstrate that naproxcinod is safe and effective for treating the signs and symptoms of osteoarthritis, in addition to collecting standardized and well-controlled cuff-measurements to demonstrate that naproxcinod has no detrimental effect on blood pressure.
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 (HCT 3012), in phase 3 development for the treatment 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 and Co., Inc.
NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a public company listed on the Eurolist of Euronext 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 of reference.
NicOx S.A.
CONTACT: Karl Hanks, Manager of Corporate Relations and Market Analysis ofNicOx, +33(0)497-15-22-03, hanks@nicox.com; or Investors in the UnitedStates: Lisa Burns, lburns@burnsmc.com, or Laura Siino, lsiino@burnsmc.com,both of Burns McClellan, +1-212-213-0006; or Jonathan Birt,+1-212-850-5634, jbirt@fd-us.com, or Julia Phillips, +44(0)20-7831-3113,julia.phillips@fd.com, both of Financial Dynamics, all for NicOx
Web site: http://www.nicox.com/
