Navigation Links
NicOx Provides an Update on the Phase 2a Study for NCX 1000,Conducted With Axcan

SOPHIA ANTIPOLIS, France, May 11, 2007 /PRNewswire-FirstCall/ -- NicOx S.A. (Eurolist: COX) today provided an update on the phase 2a study for NCX 1000, which is covered by its codevelopment 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 pharmacokinet ics.

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 Devel opment 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 Euronext(TM) 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.

CONTACTS: http://www.nicox.com

NicOx: Karl Hanks - Manager of Corporate Relations and Market Analysis - Tel +33 (0) 4 97 24 53 42 - hanks@nicox.com

Investors in the United States - Burns McClellan: Lisa Burns - , Laura Siino - - Tel +1 212 213 0006 lburns@burnsmc.com lsiino@burnsmc.com

Media - FD: Jonathan Birt - Tel +1 212 850 56 34 - jbirt@fd-us.com

CONTACT: Karl Hanks, Manager of Corporate Relations and Market Analysis,of NicOx, +33 (0) 4 97 24 53 42, ; or Investors in theUnited States: Lisa Burns, , or Laura Siino,, both of Burns McClellan, +1-212-213-0006; or Media:Jonathan Birt of FD, +1-212-850-5634, hanks@nicox.com lburns@burnsmc.com lsiino@burnsmc.com jbirt@fd-us.com

Web site: http://www.nicox.com//

Ticker Symbol: (:NICXF),(NASDAQ-NMS:AXCA),(Toronto:AXP.)

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Largest Cervical Cancer Vaccine Efficacy Trial Shows Cervarix Provides Excellent Protection Against Lesions Caused by Most Common Cancer-Causing Virus Types
2. XTL Provides Update on Phase I Clinical Trial of XTL-2125
3. Cervarix, the GSK Cervical Cancer Candidate Vaccine, Provides Sustained Immune Response in 100 Percent of Women up to 55 Years of Age
4. Daytrana (methylphenidate transdermal system) Provides Significant Effectiveness in ADHD Symptom Relief in Both Boys and Girls
5. DURECT Provides an Update to the Memryte Program Under Development by Voyager Pharmaceutical Corp
6. Indivumed Study Provides Sound Scientific Basis for a Predictive Drug Test- Platform
7. Rigel Provides Clinical Update of R788 Phase 2 Trials in ITP, Rheumatoid Arthritis and Lymphoma
8. New Analysis of Data from WHI Provides Reassurance With Respect to Coronary Heart Disease For Newly Menopausal Women Considering Hormone Therapy
9. Cell Genesys Provides Final Median Survival Data From Second Phase 2 Trial of GVAX Immunotherapy for Prostate Cancer
10. Novavax Vaccine Provides Robust Immune Response, Pre-Clinical Data Show
11. NeoPharm Provides Update on LE-SN38 Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/7/2016)... India , December 7, 2016 According to ... (Services, Software), Delivery Mode, Product Type (Integrated, Standalone), Model (Knowledge-Based), Type (Therapeutic, ... MarketsandMarkets, The CDSS Market is expected to reach USD 1,519.2 Million by ... Continue Reading ... ...
(Date:12/7/2016)... , Dec. 7,2016  Based on ... delivery industry, Frost & Sullivan recognizes Nemaura ... & Sullivan Award for Enabling Technology Leadership. ... the loopholes in traditional drug delivery technologies, ... liquid microneedle-based drug delivery technologies, Memspatch and ...
(Date:12/7/2016)... Inc. (NASDAQ: IONS ), the leader in antisense therapeutics, ... BMO Capital Markets Prescriptions for Success Healthcare Conference on Wednesday, December ... A live webcast of the presentation will be available on the ... be available within 48 hours and will be archived for a ... , , ...
Breaking Medicine Technology:
(Date:12/7/2016)... ... , ... “The Road To Restoration”: an informative and enlightening book for ... week showing of hands. “The Road To Restoration” is the creation of published author, ... the brass ring that you could reach out for, and grab, on the old ...
(Date:12/7/2016)... ... ... “Walking With God: Inspirational Lessons from My Life's Journey”: a sometimes serious, ... God's direction in their lives. “Walking With God: Inspirational Lessons from My Life's Journey” ... , Sanford says, “I enjoy sharing the true stories in my book ...
(Date:12/7/2016)... ... (PRWEB) December 07, 2016 , ... Angioma Alliance ( ... cavernous angiomas, was awarded a grant from the Julian Grace Foundation to increase ... has more people with cavernous angioma than anywhere in the world. Most share ...
(Date:12/7/2016)... ... 07, 2016 , ... Dr. Greg Leyer, the Chief Scientific ... Washington DC workshop on November 2nd. The conference was an opportunity for both ... supplement regulations. , Dr. Leyer spoke about two main topics at the ...
(Date:12/7/2016)... ... 2016 , ... "Hacking into my medical record wouldn’t be hard for my ... begins "Margaret in Berlin," Book Twelve in the Margaret of Greenwich ® Young ... These novels narrate the lives of a poor teenager and her wealthy friends in ...
Breaking Medicine News(10 mins):