Enrollment completed five months early in NicOx phase 3 trial of HCT 3012 for osteoarthritis

By Lisa Kerner

Erie, Pa., May 24 - NicOx SA said it has completed patient enrollment ahead of schedule in its first phase 3 trial for HCT 3012, a novel, proprietary, nitric oxide-donating derivative of naproxen.

The company plans to develop HCT 3012 as the drug of choice for osteoarthritis patients, in particular, those with coexisting hypertension (high blood pressure).

Randomization of 820 patients with osteoarthritis of the knee began in December at 120 clinical sites in the United States.

Results from the trial are expected in the fourth quarter of 2006, according to a company news release.

The 13-week, double-blind, phase 3 trial is designed to demonstrate that HCT 3012 is superior to a placebo and as effective as naproxen in relieving the signs and symptoms of osteoarthritis, with no detrimental effect on blood pressure.

Primary endpoints, based on the mean change between baseline and week 13, will be measured using scores from the WOMAC pain subscale, the WOMAC function subscale and patients' overall rating of disease status.

A recently started, additional trial uses ambulatory blood pressure monitoring to compare the 24-hour blood pressure profile of HCT 3012 and naproxen in subjects with high blood pressure.

"The completion of enrolment in this phase 3 study in under five months represents a very significant achievement," vice president of clinical development Maarten Beekman said in the release.

"We believe this performance reflects the strength of the clinical team we have assembled at NicOx and the excellent collaboration with PRA International, a leading contract research organization."

According to the release, 43 million people in the United States suffer from arthritis, 40% of whom are also hypertensive.

NicOx, based in Sophia-Antipolis, France, is a product-driven biopharmaceutical company dedicated to the development of nitric oxide-donating drugs to meet unmet medical needs.

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