Press Release: NicOx Provides Update on Phase 2a Study for NCX 1000 Conducted With Axcan Pharma; Companies Scrap drug
NicOx Provides Update on Phase 2a Study for NCX 1000 Conducted With Axcan Pharma; Companies Scrap drug; NicOx Shares Fall SOPHIA ANTIPOLIS, FRANCE -- May 11, 2007 NicOx S.A. today provided an update on the phase 2a study for NCX 1000, which is covered by its co-development agreement with Axcan Pharma Inc. A preliminary analysis of 11 patients from this proof-of-concept study in portal hypertension confirmed the safety profile of NCX 1000 but did not demonstrate the efficacy required to support the continuation of this clinical trial. As a consequence, Axcan and NicOx have agreed not to further pursue the development of NCX 1000 and to terminate the trial. The trial was a phase 2a, double-blind, dose-escalating proof-of- concept study in which 11 patients with portal hypertension were enrolled in a single clinical center in Spain. Portal hypertension is abnormally raised blood pressure in the portal vein, which carries blood from the digestive system to the liver (see NOTE). Patients were 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 was followed by 2000mg (or the maximum tolerated dose) three times a day for the following 14 days. The primary endpoint of the trial was defined as the comparison between patients' portal pressure in the fasting state on day 16 of treatment with the corresponding baseline values. A secondary endpoint was the same comparison following the consumption of a controlled meal and additional endpoints were based on the response rate (defined in terms of portal pressure reduction), the increase in liver blood flow, clinical safety, tolerability and pharmacokinetics. NCX 1000 showed good safety and tolerability, confirming the results observed in two previous phase 1 studies, and NicOx and Axcan will now proceed with further data analysis and full results will be disclosed at a later date. Maarten Beekman, Vice President of Clinical Development at NicOx, commented: "This ambitious project, jointly conducted by Axcan and NicOx aimed to develop an efficacious treatment for portal hypertension, a life threatening complication of chronic liver disease. This indication represents a major therapeutic challenge as the processes of the disease are not well understood and there are currently no treatments available. Unfortunately, NCX 1000 did not demonstrate the efficacy required to justify further development, although we are pleased that the safety and tolerability of the product were good." NOTE: 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. 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 the 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 and Co., Inc. NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a public company listed on the Eurolist of EuronextTM 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.