450 patients with symptomatic peripheral arterial obstructive disease (PAOD) and intermittent claudication (leg pain during walking) have been recruited. The phase II trial was designed with an independent steering committee to evaluate the effects of NCX 4016 on clinical parameters in PAOD with particular regard to walking distance.
The primary endpoint of the trial is the change in maximum treadmill walking distance after six months, an endpoint recognized by the FDA and other regulatory authorities for approving new treatments for symptomatic PAOD.
The study, which follows a successful phase II pilot study, is expected to be completed in the second half of 2005, and results will be made available following analysis of the data in the last quarter of 2005.
Following the results of this trial, NicOx is planning to evaluate NCX 4016 in other indications. “NCX 4016 has the potential for future development in a broad range of endothelium dysfunction-related disorders, especially in diabetic and atherosclerotic patients, and we plan to explore this potential in an expanded phase II program,” Michele Garufi, chairman and CEO of NicOx, commented.