naproxcinodTreatment for Duchenne Muscular Dystrophy
Nicox to re-focus Naproxcinod on Duchenne Muscular Dystrophy
Sophia Antipolis, France - February 14, 2014 -- Nicox S.A. (NYSE Euronext Paris: COX) today announced its decision to re-focus naproxcinod development efforts. Nicox has granted an undisclosed financial partner the right to enter into a period of exclusive evaluation to assess the potential development of naproxcinod and of next generation nitric oxide (NO)-donors outside the ophthalmology area. The evaluation will be entirely funded by this partner and will be focused initially on Duchenne muscular dystrophy (DMD). Nicox has granted the undisclosed partner the exclusive right, should the results of the evaluation be satisfactory to the partner, to invest at the end of the evaluation period in naproxcinod and next generation NO-donors outside ophthalmology through an independent structure. Nicox will not pursue any other development activities or discussions with third parties related to naproxcinod.
Naproxcinod is a CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory candidate. In October 2013, the European Commission granted Orphan Drug Designation for naproxcinod for the treatment of DMD. DMD is the most common and serious form of muscular dystrophy, a group of inherited diseases that cause muscle weakness and muscle loss. Promising preclinical results obtained with naproxcinod in models of muscular dystrophy were presented at the Muscular Dystrophy Association Scientific Conference in Washington, DC, in April 2013, and at the International Congress of the World Muscle Society in Asilomar, CA in October 2013, and have been published in Human Molecular Genetics in early 20141.
1 Long-term treatment with naproxcinod significantly improves skeletal and cardiac disease phenotype in the mdx mouse model of dystrophy, Uaesoontrachoon K, Quinn JL, Tatem KS, Van der Meulen JH, Yu Q, Phadke A, Miller BK, Gordish-Dressman H, Ongini E, Miglietta D, Nagaraju K. Hum Mol Genet. 2014, Early online publication Jan 23, 2014.
Posted: February 2014
- Nicox Receives Orphan Drug Designation from FDA for Naproxcinod in Duchenne Muscular Dystrophy - March 19, 2015
- NicOx Provides Update on U.S. Regulatory Status of Naproxcinod - April 4, 2012
- FDA provides Complete Response Letter to NicOx's New Drug Application for naproxcinod - July 22, 2010
- NicOx provides update on FDA Advisory Committee Meeting for naproxcinod - May 13, 2010
- NicOx announces FDA Advisory Committee to discuss naproxcinod on May 12 - March 8, 2010
- NicOx announces FDA accepts naproxcinod NDA for filing - November 18, 2009
- NicOx submits New Drug Application (NDA) for naproxcinod to the US FDA - September 25, 2009