NicOx study shows NCX 4016 improves insulin sensitivity, heart stroke volume in diabetic patients

By Angela McDaniels

Seattle, Nov. 16 - NicOx SA said the results of a 13-patient, exploratory phase 2a study in patients with type 2 diabetes and early nephropathy showed that those who received NCX 4016 experienced a statistically significant improvement in insulin sensitivity and systemic hemodynamics.

Additionally, the amount of blood pumped to the body by each heart beat was significantly higher following treatment with NCX 4016, accompanied by a significant decrease in the force opposing blood flow, the company said.

NCX 4016 also showed a statistically significant advantage over aspirin in terms of overnight albuminuria, a marker of kidney damage, and in preventing increased arterial systolic blood pressure.

Aspirin, together with the related non-steroidal anti-inflammatory drugs, is known to put patients at risk of high blood pressure and kidney damage, the company said.

"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," said Ali Raza, head of research and development, in a company news release.

The trial was conducted at the Mario Negri Institute in Bergamo, Italy, and followed a randomized, double blind, cross-over design. Patients received NCX 4016 (800 mg twice daily) and aspirin (325 mg once daily) for 4 weeks.

The data was reported Tuesday in an oral presentation at the American Heart Association Scientific Sessions 2005 in Dallas.

NicOx, headquartered in Sophia-Antipolis, France, is a pharmaceutical company that develops nitric oxide-donating drugs for the treatment of inflammation, pain and cardiovascular disease.

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