Vasogen phase 3 study of Simpadico for PAD does not meet primary endpoint

By Lisa Kerner

Erie, Pa., March 13 - Vasogen Inc. said results from the 553-patient phase 3 Simpadico trial of its Celacade technology in peripheral arterial disease (PAD) indicate that the primary endpoint - change in maximal treadmill walking distance - was not reached.

However, Celacade significantly reduced high sensitivity C-reactive protein (hs-CRP), a pre-specified endpoint and a marker of systemic inflammation associated with increased cardiovascular risk, including heart failure, stroke and heart attack, according to a company news release.

The results were being presented Monday at the 55th Annual Scientific Session of the American College of Cardiology in Atlanta by Dr. Jeffrey Olin, principal investigator and chairman of the steering committee for the Simpadico trial.

"We are obviously disappointed that Celacade was not shown to improve walking distance in PAD, one of the most difficult endpoints in which to demonstrate a therapeutic benefit," said Olin in a news release. "It is very interesting to note, however, the finding of a significant reduction in C-reactive protein, a well recognized inflammatory marker that is associated with increased risk of cardiovascular events."

The Simpadico study screened 947 patients and randomized 553 subjects. The placebo and Celacade groups were well balanced for baseline characteristics, including demographics, maximal treadmill walking distance, smoking history, concomitant medical conditions and medications.

According to the company, there were no significant differences between the placebo and Celacade groups in percentage increase in ACD between baseline and 26 weeks, or in the pain-free treadmill walking distance.

Celacade was shown to be well tolerated in this patient population, who were receiving standard-of-care medications for atherosclerosis and PAD, including statins, beta-blockers, anti-platelet agents and ACE-inhibitors, the release stated.

Study treatments were terminated early based on a recommendation by the study's External Safety and Efficacy Monitoring Committee, due in part an observed imbalance in the distribution of malignancy cases.

Toronto-based Vasogen is focused on the research and commercial development of technologies targeting the chronic inflammation underlying cardiovascular and neurological disease.

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