June 22, 2006 01:06 ET

NicOx announces patient enrolment ongoing in NCX 1000 phase 2 study

Sophia Antipolis Cedex -- (MARKET WIRE) -- June 22, 2006 -- June 22, 2006. Sophia Antipolis, France.

NicOx S.A. (Eurolist: NICOX) today announced that patient enrolment is ongoing in a phase 2a trial aimed at assessing the efficacy of NCX 1000 in portal hypertension, through the measurement of portal pressure. The selected clinical center, which had been actively identifying potential patients for a number of months, has now completed all administrative procedures and was able to effectively randomize the first patient. This phase 2a study is a randomized, double blind, dose escalating study, which will enroll patients with portal hypertension who will receive escalating doses of NCX 1000 or placebo.

NCX 1000 is a patented, nitric oxide-donating derivative of ursodeoxycholic acid (UDCA), which is being developed for the treatment of portal hypertension and other complications of chronic liver disease under a co-development and license agreement between NicOx and Axcan Pharma Inc.

Maarten Beekman, Vice President Clinical Development at NicOx, commented: "Portal hypertension is an extremely serious complication of chronic liver disease. A third of patients are estimated to suffer from esophageal bleeding and the mortality per bleeding episode can be as high as 50%. The joint NicOx-Axcan team has been working very hard to achieve all regulatory and other approvals necessary for this important trial, which aims to provide a treatment for this inadequately served disease. We are impressed by the enthusiasm of the selected clinical center and are looking forward to the outcome of this study."

Study design

This trial is a double-blind, dose escalating study with a placebo group, which will enroll patients with portal hypertension (abnormally raised blood pressure in the portal vein that brings blood from the digestive system to the liver). Patients will be randomized to receive either placebo or escalating doses of NCX 1000 (500mg, 1000mg and 2000mg as the first three doses during the first two days). This will be followed by 2000mg (or the maximum tolerated dose) three times a day for the following 14 days. The primary endpoint of the trial will compare the patients' portal pressure in the fasting state on day 16 of treatment with the corresponding baseline values. A secondary endpoint will make the same comparison following the consumption of a controlled meal and additional endpoints will follow the response rate (defined in terms of portal pressure reduction), the increase in liver blood flow, clinical safety, tolerability and pharmacokinetics.

Portal hypertension is the most common manifestation of chronic liver disease and is responsible for the majority of the morbidity and mortality related to this disorder. The condition is caused by increased resistance to blood flow through the liver due to structural and blood flow changes. Consequently, blood is forced to return to the heart using other vessels, which are not adapted to high pressure and therefore rupture, causing life threatening bleeding. Deficient nitric oxide signaling is believed to be involved in the constriction of small blood vessels in the liver which contributes to portal hypertension and preclinical studies have demonstrated that NCX 1000 can potentially counteract abnormally raised pressure in the portal vein. Two phase 1 studies have been conducted to evaluate the pharmacokinetics and tolerability of NCX 1000 in man and both trials showed good tolerability and safety.

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 osteoarthritis, and NCX 4016, in phase 2 for Peripheral Arterial Obstructive Disease (PAOD). 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 de reference.


NicOx: Karl Hanks - Manager of Corporate Relations and Market Analysis - Tel +33 (0)497 15 22 03 - -

Investors in the United States - Burns McClellan: Lisa Burns - / Laura Siino - - Tel +1 212 213 0006

Financial Dynamics: Jonathan Birt - Tel +1 212 850 56 34 - / Julia Phillips - Tel +44 (0)20 7831 3113 -

NicOx S.A.,

2455 route des Dolines, Espace Gaïa II, BP313, 06906 Sophia Antipolis cedex, France. Tel. +33 (0)4 9238 7020 - Fax +33 (0)4 9238 7030

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