November 14, 2005 02:00 ET

NicOx announces results of a phase 2 trial for NCX 4016 in PAOD

Sophia-Antipolis cedex -- (MARKET WIRE) -- November 14, 2005 -- November 14, 2005. Sophia Antipolis, France.

NicOx S.A. (Eurolist: NICOX) today announced that a phase 2 trial for NCX 4016 in Peripheral Arterial Obstructive Disease (PAOD) has not met its primary endpoint in terms of demonstrating a statistically significant advantage over placebo. The primary endpoint of the trial was the change in absolute treadmill walking distance after six months of treatment, versus placebo, compared to baseline. A statistically significant advantage was seen for NCX 4016 in a pre-defined sub-group of patients with type 2 diabetes. Full analysis of the data is ongoing, including an examination of pre-defined secondary end-points and safety and tolerability. NCX 4016 is a novel, proprietary, nitric oxide-donating derivative of acetylsalicylic acid, which NicOx is developing in a range of cardiovascular and related disorders.

Michele Garufi, Chairman and CEO of NicOx, commented: "We are disappointed with the top-line result of this trial but we will not be making any decisions on whether to continue the development of NCX 4016 in PAOD until all the data have been more completely analyzed. The results in diabetic patients merit further examination when taken together with other data in this clinical setting, including new results from an exploratory trial that will be presented later this week at the 2005 American Heart Association meeting."

Trial Design and Results

The trial was a randomized, double-blind, placebo-controlled study, which enrolled 442 patients at 34 clinical sites throughout Europe (see NOTE 1). The trial enrolled patients with Leriche-Fontaine stage II PAOD (showing symptoms of intermittent claudication, or leg pain during walking). Eligible patients were randomized to treatment with either NCX 4016 800 mg bid. or placebo for 6 months. All patients also received low-dose aspirin (100 mg od.). The primary objective of the study was to evaluate the clinical efficacy of NCX 4016 in PAOD and the primary endpoint was the change in maximal treadmill walking distance (absolute claudication distance) after six months, where NCX 4016 showed a non-significant advantage over placebo (p=0.276). Analysis of the data from a pre-defined patient sub-group with type 2 diabetes (approximately 30% of the study population) showed a statistically significant advantage for NCX 4016 compared to placebo in absolute walking distance (p=0.038). Promising data have previously been seen for NCX 4016 in type 2 diabetes patients (see NicOx press release of March 1, 2005, and presentations to be made at the American Heart Association on November 14 and 15, 2005). As was expected, a significant placebo effect was seen in the trial.

Normally, the first symptom of PAOD is intermittent claudication, a disabling pain on walking which can be relieved by rest. The disease is believed to be caused by atherosclerosis and dysfunction of the endothelium in the lower limbs, which decreases the ability of the arteries to adequately supply the increased demand for oxygen that occurs in the muscles during exercise. Progression of the disease can lead to ischemic pain during rest (i.e. due to a lack of oxygen), ulceration, gangrene and in some cases limb amputation.

Professor Paolo Gresele, Professor of Internal Medicine at the University of Perugia and Principal Investigator on the trial, commented: "The main goal of symptomatic treatment in stage II PAOD is to relieve the symptoms of intermittent claudication and improve walking capacity. These results are a disappointment for PAOD patients, as current therapies are associated with only modest efficacy and there is a clear need for more effective drugs. However, PAOD is known to be an extremely challenging area for clinical development, due to the high variability in the course of the disease and the marked placebo effect that is expected in any study."

NOTE 1: The trial enrolled male and female patients, aged 40-80, with Leriche-Fontaine stage II PAOD, who had been exhibiting symptoms of intermittent claudication for the last 6 months. Enrollment criteria included objective evidence confirming the clinical diagnosis of PAOD (i.e. an ankle/brachial index, the ratio of the blood pressure recorded at the ankle and the arm < 0.9), plus an absolute claudication distance < 500 m and an initial claudication distance > 50 m in a standardized treadmill test. Patients also needed to be clinically stable (i.e., demonstrate a change in absolute claudication distance not exceeding 25% in two treadmill tests during the 14-day run-in period).

NicOx S.A. is an emerging pharmaceutical company involved in the research and development of nitric oxide-donating drugs with superior efficacy and safety profiles in the inflammation, pain and cardiovascular therapeutic areas.

NicOx seeks to commercialize its products through partnerships and co-development agreements where it maintains future marketing rights for specialist products.

NicOx S.A. (Bloomberg: COX:FP, Reuters: NCOX.LN), headquartered in Sophia-Antipolis, France, 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 de reference.


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