Vasogen says part of phase 3 study of Celacade technology completed

By Ted A. Knutson

Washington, Jan. 4 - Vasogen Inc. announced Wednesday that database lock for the phase 3 Simpadico trial of its Celacade technology in peripheral arterial disease has been completed. A meeting of the independent steering committee for the Simpadico trial is expected to take place early next month to analyze and interpret the data.

Peripheral arterial disease is a serious condition of impaired blood flow to the lower extremities resulting from atherosclerosis.

Vasogen said it is well established that inflammatory pathways are implicated in the development and progression of atherosclerosis. The disease often leads to reduced mobility and a marked impairment in the ability to undertake the basic activities of daily independent living. It is estimated that in the United States alone, peripheral arterial disease affects about 7 million people, with related health care costs exceeding $10 billion annually.

Vasogen said Simpadico represents one of the largest clinical trials conducted with a anti-inflammatory strategy targeting intermittent claudication and is the first of two pivotal phase 3 studies designed to further assess the impact of the Celacade technology on pathological mechanisms not currently addressed in cardiovascular disease.

The trial is designed to support regulatory approval in North America and commercialization in North America and Europe. The primary endpoint of the study is the change in maximum walking distance at six months; an endpoint recognized by the Food and Drug Administration and other regulatory authorities for approving new treatments for intermittent claudication.

The study is also designed to investigate the impact of Celacade on additional clinical endpoints, including peripheral arterial disease and cardiovascular-related events, as well as quality of life.

Vasogen is a Mississauga, Ont., pharmaceutical company focused on research and commercial development of technologies targeting the chronic inflammation underlying cardiovascular and neurological disease.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.