SOPHIA ANTIPOLIS, France, May 23 /PRNewswire-FirstCall/ -- NicOx S.A. (Eurolist: NICOX) informs you that its partner, TOPIGEN Pharmaceuticals, Inc., issued a press release today (http://www.marketwire.com/mw/release_html_b1?release_id=130749 ) announcing the initiation of its phase 2 development program for TPI-1020 (formerly NCX 1020) in respiratory disorders. TOPIGEN aims to develop TPI-1020 as a treatment for chronic obstructive pulmonary disease (COPD), which could be more effective than conventional corticosteroids. TPI-1020 is a novel, inhaled, nitric oxide (NO)-donating derivative of budesonide, for which TOPIGEN licensed North American rights and an option on worldwide rights from NicOx in 2005 (see press release of October 27, 2005).
The first phase 2 clinical trial initiated by TOPIGEN has the primary objective of assessing the general safety, tolerability and pharmacodynamic activity of inhaled TPI-1020 in smokers with asthma and is expected to be followed by a subsequent trial in COPD. This first trial announced today in asthmatic smokers is a 21-day, multi-center, randomized, double-blind study, which will evaluate repeated and ascending doses of either TPI-1020 or budesonide in two treatment groups of 15 subjects per group. Secondary objectives will assess preliminary efficacy measurements.
Damian Marron, Vice President of Corporate Development at NicOx commented: “We are very pleased to have entrusted the development of TPI-1020 to TOPIGEN, who have a strong expertise in the respiratory area and are clearly resolved to execute on the aggressive clinical plan they have designed. This progress validates NicOx’ continued strategy of signing research and development partnerships on its NO-donating compounds in non-core therapeutic areas.”
COPD is characterized by persistent airflow limitation of the lungs and represents the fourth leading cause of death in the United States. TPI-1020 has been shown to be more effective than budesonide at blocking the recruitment of inflammatory cells (neutrophils) in rodent models of airway inflammation and pulmonary disease. Neutrophils are immune cells that play a central role in the pathology and exacerbations of COPD.
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 inflammatory and cardio-metabolic diseases. Resources are focused on two lead compounds, 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.
CONTACTS: NicOx: Karl Hanks, Manager of Corporate Relations and Market Analysis, Tel +33 (0)497 15 22 03, hanks@nicox.com, http://www.nicox.com Investors in the United States - Burns McClellan: Lisa Burns, lburns@burnsmc.com / Laura Siino, lsiino@burnsmc.com, Tel +1 212 213 0006 Financial Dynamics: Jonathan Birt, Tel +1 212 850 56 34, jbirt@fd-us.com / Julia Phillips, Tel +44 (0)20 7831 3113, julia.phillips@fd.com
NicOx S.A.
CONTACT: NicOx: Karl Hanks, Manager of Corporate Relations and MarketAnalysis, +33-(0)497-15-22-03, hanks@nicox.com; Investors in the UnitedStates - Burns McClellan: Lisa Burns, lburns@burnsmc.com, or Laura Siino,lsiino@burnsmc.com, +1-212-213-0006; Financial Dynamics: Jonathan Birt,+1-212-850-5634, jbirt@fd-us.com, or Julia Phillips, Tel+44-(0)20-7831-3113, julia.phillips@fd.com
Web site: http://www.nicox.com/
