NicOx begins trial to establish HCT 3012 as osteoarthritis treatment for hypertension patients

By E. Janene Geiss

Philadelphia, May 4 - NicOx SA announced Thursday the start of a clinical study designed to compare the 24-hour blood pressure profile of HCT 3012 and naproxen, using ambulatory blood pressure monitoring.

This study is expected to enroll about 120 volunteer subjects with stable essential hypertension high blood pressure at 15 clinical centers in the United States. The first subject has been enrolled and results are expected in the fourth quarter of 2006, according to a company news release.

HCT 3012 is a novel, proprietary, nitric oxide-donating derivative of naproxen, which is in phase 3 clinical development for the treatment of the signs and symptoms of osteoarthritis.

In addition to confirming the product's efficacy and overall safety in patients with osteoarthritis, the phase 3 program aims to demonstrate that HCT 3012 has no detrimental effect on blood pressure and for this reason standardized, controlled, office blood pressure measurements are being made in the ongoing phase 3 trial, officials said.

The trial is expected to provide key complementary data, by describing the blood pressure effect of HCT 3012 and naproxen over 24 hours in volunteer hypertensive subjects.

The anti-inflammatory agents currently used in the treatment of osteoarthritis are known to raise blood pressure and interfere with the treatment of hypertension.

NicOx said it aims to develop HCT 3012 as the drug-of-choice for the symptomatic treatment of osteoarthritis by demonstrating that it has no detrimental effect on blood pressure.

"Cardiovascular safety concerns have become a determining factor in influencing the prescription of anti-inflammatory agents and we believe that HCT 3012 will be a great commercial success if we demonstrate that it does not raise blood pressure," Michele Garufi, chairman and chief executive officer, said in the release.

NicOx is a Sophia Antipolis, France, product-driven biopharmaceutical company that develops nitric oxide-donating drugs to treat pain, inflammation and cardio-metabolic disease.

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