NicOx S.A. (NYSE Euronext Paris: COX) announced that Dr. Jacques Djian, Vice President of Exploratory Development and Translational Medicine at NicOx, recently presented results from the phase 1b first-in-man study for NCX 6560 in an oral session of the American Heart Association (AHA) 2010 Scientific Sessions being held in Chicago, Illinois. NCX 6560 is an innovative nitric oxide (NO)-donating New Molecular Entity (NME) targeting patients with Acute Coronary Syndrome (ACS).

The oral presentation of Dr. Djian included further details of the phase 1b study results disclosed in November 2009 (see NicOx press release dated November 13, 2009). In this two-week study, NCX 6560, an NO-donating atorvastatin, appeared safe and well tolerated. A dose-related LDL-cholesterol decrease was observed, with the highest tested dose of NCX 6560 (144 mg) reaching a 57% reduction after two weeks of treatment. No significant increase in liver enzymes was observed, even at the highest dose, which was not different from atorvastatin 40 mg. Interestingly, NCX 6560 48 mg had the same lipid-lowering effects as atorvastatin 40 mg despite a lower exposure to atorvastatin and its active metabolites. NO donation from NCX 6560 is expected to enhance the pleiotropic effects of statins outside of lipid lowering. Preclinical studies have shown that NCX 6560 demonstrated superior anti-thrombotic and anti-inflammatory properties, and greater effects on endothelial function than an equivalent dose of atorvastatin. Preclinical results suggesting promising anti-inflammatory and anti-atherogenic effects were also presented during the AHA 2010 Scientific Sessions2. NicOx is currently seeking partners to advance the clinical development of NCX 6560.

References

(1) Djian JP, Maucci R, Guilmin L, Ferreira T, Pfister P, Abstract 14267: NCX 6560, a Novel Nitric Oxide Donating Atorvastatin With a Promising Safety and Efficacy Profile: A Randomised, Double Blind Placebo and Active Control Study, Circulation 2010, 122, A14267.

(2) Momi S, Falcinelli E, Alberti FP, Monopoli A, Miglietta D, Ongini E, Gresele P, Abstract 15758: Anti-Inflammatory and Anti-Atherogenic Activities of NCX 6560, a Nitric Oxide (NO)-Donating Statin, in Hypercholesterolemic Mice, Circulation 2010, 122: A15758.

Source: NicOx