Vasogen says two phase 3 Celacade trials for cardiovascular disease near completion

By E. Janene Geiss

Philadelphia, Dec. 7 - Vasogen Inc. announced Wednesday that its Simpadico trial has completed its 12-month assessments of 550 patients with peripheral artery disease and its counterpart Acclaim trial for chronic heart failure is nearing completion.

The studies are double-blind, placebo-controlled pivotal phase 3 trials designed to support regulatory approval and commercialization of Vasogen's lead product, the Celacade technology, in North America and Europe, according to a company news release.

"The need for a novel approach to treat the chronic inflammation underlying a number of cardiovascular diseases continues to gain support in the scientific and medical communities. Our Celacade technology, which represents a significant commercial opportunity for Vasogen, is designed to target this chronic inflammation and we are looking forward to reporting the results from our phase 3 trials in peripheral arterial disease and chronic heart failure over the coming months," David Elsley, president and chief executive officer of Vasogen, said in the release.

The phase 3 Simpadico trial is designed to further investigate the use of the Celacade technology to improve intermittent claudication, a debilitating symptom associated with peripheral arterial disease.

The primary endpoint is the change in maximum walking distance at six months, an endpoint recognized by the FDA and other regulatory authorities for approving new treatments for intermittent claudication. The study also is designed to investigate the impact of Celacade on additional endpoints, including peripheral arterial disease and cardiovascular-related events and quality of life at six and 12 months.

All patients completed their six-month primary endpoint assessments in July 2005 and, pursuant to an agreement with the FDA, the 12-month assessments for all patients have now also been completed, officials said.

The trial database is being verified and is expected to be locked prior to the end of this year. Once the database is locked, the Simpadico Steering Committee will meet to un-blind the data and analyze the study results.

This meeting is expected to take place in late January or early February, following which results of the study and plans for presentation and publication of the data will be made public, officials said.

The 2,400-patient pivotal phase 3 Acclaim trial is now approaching completion at 176 clinical centers in North America, Europe and Israel.

The trial is designed to definitively assess the impact of Vasogen's Celacade technology on reducing the risk of death and cardiovascular hospitalization in patients with advanced chronic heart failure. It will conclude when at least 701 patients sustained a primary endpoint event, defined as either a death or first cardiovascular hospitalization, and all patients had been in the study for a minimum of six months.

The trial completed patient enrollment in May 2005 and reached the pre-specified objective of 701 primary endpoint events in November 2005, officials said.

Vasogen said that all patients now have now been in the study for a minimum of six months. The final patient assessments are expected to be completed next month, following which preparations for database lock and data analysis will begin.

The results of the study and plans for presentation and publication of the data are expected to be made public during the first half of 2006, officials said.

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

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