NicOx presents new preclinical data for NCX 6560
September 19, 2011. Sophia Antipolis, France. www.nicox.com
NicOx S.A. (NYSE Euronext Paris: COX) today announced that new preclinical results obtained with NCX 6560 were presented at the European Muscle Conference in Berlin, the annual meeting of the European Society for Muscle Research. NCX 6560 is an innovative nitric oxide (NO)-donating atorvastatin which has previously completed a successful phase 1b study, including a preliminary evaluation of its cholesterol-lowering effect in subjects with high LDL (Low Density Lipoprotein)-cholesterol. NicOx is currently evaluating select cardiovascular indications for NCX 6560 where NO donation may bring the greatest therapeutic benefits.
Statins are commonly used for lowering abnormally raised cholesterol but are associated with side effects, including skeletal muscle adverse events such as pain and weakness. Observational studies estimate that 10 to 15% of statin users experience muscle-related adverse events, known as statin-induced myopathy, which may lead them to discontinue the treatment. This is a significant problem for patients at high risk of cardiovascular events who need to maintain efficacious lipid-lowering therapy.
The study presented at the European Muscle Conference assessed the effects of atorvastatin, a reference statin, and NCX 6560 on muscle function in a preclinical model. In this model, atorvastatin affected muscle function and induced muscle fiber atrophy. NCX 6560, at a dose producing the same plasma level of atorvastatin, did not show these adverse effects, which suggests that NO may have a beneficial effect in preventing statin-induced myopathy. The abstract has been published in the Journal of Muscle Research and Cell Motility.
 Abd TT, Jacobson TA, Statin-induced myopathy: a review and update. Expert Opin. Drug Saf. 2011, 10(3):373-87.
 D'Antona G, Mascarto A, Monopoli A, Miglietta D, Ongini E, Bottinelli R, Nitric oxide preserves from atorvastatin-induced skeletal muscle damage in mice. J Muscle Res Cell Motil. 2011, in press.
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a pharmaceutical company focused on the research, development and future commercialization of drug candidates. NicOx is applying its proprietary nitric oxide-donating R&D platform to develop an internal portfolio of New Molecular Entities (NMEs) for the potential treatment of inflammatory, cardio-metabolic and ophthalmological diseases.
The Company's pipeline includes several nitric oxide-donating NMEs, which are in development internally and with partners, who include Merck (known as MSD outside the United States and Canada), Bausch + Lomb, and Ferrer.
NicOx S.A. is headquartered in France and is listed on Euronext Paris (Compartment B: Mid Caps).
This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated in the forward-looking statements.
Risks factors which are likely to have a material effect on NicOx's business are presented in the 4th chapter of the « Document de référence, rapport financier annuel et rapport de gestion 2010 » filed with the French Autorité des Marchés Financiers (AMF) on February 25, 2011 and available on NicOx's website (www.nicox.com) and on the AMF's website (www.amf-france.org).
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Posted: September 2011