Early close of trial of treatment for peripheral arterial disease announced
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Vasogen Inc. (VSGN), focused on the development of immune modulation therapies for the treatment of cardiovascular disease, announced the early close out of the 550-patient, double-blind, placebo-controlled Phase 3 SIMPADICO trial of its Celacade technology for the treatment of symptomatic peripheral arterial disease (PAD).
The decision to close out the trial at this time is based on a recommendation received from the SIMPADICO Steering Committee.
The Steering Committee’s recommendation was based on a recommendation by the trial’s External Safety and Efficacy Monitoring Committee (ESEMC). The ESEMC recommended the early close out of the study based on the absence of a sufficiently strong efficacy signal and their observation of a modest imbalance in the distribution of a small number of malignancy cases.
Based on the steering committee’s own review and the findings of an independent expert in medical oncology, the steering committee concluded that no safety concern existed. However, given that the ESEMC’s analysis also incorporated efficacy information and all patients have completed the assessments necessary for the analysis of the primary endpoint, the steering committee recommended the early close out of the trial.
The SIMPADICO trial enrolled 553 patients with moderate to severe PAD at 50 centers throughout North America. The study population was predominantly male (72%), Caucasian (89%), current or ex-smokers (91%), with a mean age of 67 years. The primary endpoint in SIMPADICO is the change in maximal walking distance after 6 months’ treatment; a primary efficacy endpoint recognized by the U.S. Food and Drug Administration (FDA) and other regulatory authorities for approving new treatments for symptomatic PAD.
Clinical assessments of the 6-month primary endpoint were completed in July of this year and the majority of patients in the study have completed an additional 6 months of therapy as outlined in the study protocol.
Vasogen is focused on the research and commercial development of technologies targeting the chronic inflammation underlying cardiovascular and neurological disease.
2005, NewsRx.com.
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