November 16, 2005 02:00 ET

NicOx announces presentation of NCX 4016 phase 2a results in type 2 diabetes at American Heart Association

Sophia-Antipolis cedex -- (MARKET WIRE) -- November 16, 2005 -- November 16, 2005. Sophia Antipolis, France.

NicOx S.A. (Eurolist: NICOX) announced today that the results of a 13-patient, exploratory phase 2a study in patients with type 2 diabetes and early nephropathy were reported yesterday in an oral presentation at the American Heart Association Scientific Sessions 2005, in Dallas, Texas. Patients who received NCX 4016 showed a statistically significant improvement in insulin sensitivity and systemic hemodynamics, compared to baseline. Treatment with NCX 4016 was also associated with potential safety advantages compared to aspirin.

Dr. Ali Raza, Head of Research and Development at NicOx, commented: "It has long been known that there is a link between metabolic disorders, such as diabetes, and cardiovascular disease. These results add further evidence that nitric oxide-donation appears to affect pathways which link these two important disorders. Nevertheless, this is a pilot trial and the results should be seen in the context of the overall development program for NCX 4016."

The trial was conducted at the Mario Negri Institute in Bergamo, Italy, and followed a randomized, double blind, cross-over design. Patients with signs of overt renal insufficiency were excluded from the trial. Stable metabolic control and adequate management of arterial blood pressure were achieved during the 4-week placebo run-in by adjusting concomitant therapies, if needed. Patients received NCX 4016 (800 mg twice daily) and aspirin (325 mg once daily) for 4 weeks, in a cross-over design.

Increase in insulin sensitivity: The results revealed a statistically significant increase in insulin sensitivity (glucose disposal rate measured by hyperinsulinemic euglycemic clamp) following treatment with NCX 4016, as compared to baseline (p < 0.05). Insulin is thought to have a dilatory effect on the small blood vessels in skeletal muscle, mediated by endothelial nitric oxide, which increases the glucose disposal rate by increasing the supply of glucose and insulin to muscle cells.

Improvement in systemic hemodynamics: Stroke volume (the amount of blood pumped to the body by each heart beat) was significantly higher following treatment with NCX 4016 compared to baseline (p < 0.05). This was accompanied by a significant decrease in peripheral vascular resistance (the force opposing blood flow) following treatment with NCX 4016, as compared to baseline (p < 0.05). This can potentially be explained by the ability of nitric oxide to improve arterial compliance (elasticity) and dilate peripheral blood vessels, reducing the strain on the heart and allowing it to pump more efficiently.

Renal protection and no unwanted increase in blood pressure: NCX 4016 also showed a statistically significant advantage over aspirin in terms of overnight albuminuria (a marker of kidney damage) (p < 0.025) and in preventing increased arterial systolic blood pressure (p < 0.025). Aspirin, together with the related non-steroidal anti-inflammatory drugs (NSAIDs), is known to put patients at risk of high blood pressure and kidney damage. The possible protective influence of nitric oxide-donation is of particular importance in diabetes patients, who are at an increased risk of both disorders.

Dr. Giuseppe Remuzzi, Director of the Mario Negri Institute for Pharmacological Research and Principal Investigator on the trial, commented: "The results of this trial have potential importance for the treatment of diabetes in general and, even more importantly, in diabetics who suffer from some forms of renal disease. These are the patients who are more vulnerable in terms of cardiovascular risk and mortality, when compared to diabetics with normal renal function."

NicOx S.A. is an emerging pharmaceutical company involved in the research and development of nitric oxide-donating drugs with superior efficacy and safety profiles in the inflammation, pain and cardiovascular therapeutic areas.

NicOx seeks to commercialize its products through partnerships and co-development agreements where it maintains future marketing rights for specialist products.

NicOx S.A. (Bloomberg: COX:FP, Reuters: NCOX.LN), headquartered in Sophia-Antipolis, France, 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.


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