Vasogen Announces Implementation of Strategic Restructuring Plan
Vasogen has encountered significant delays with the FDA regarding the design of ACCAIM II, a clinical trial to support an application for U.S. market approval of Celacade for the treatment of patients with NYHA Class II heart failure. Given these delays, Vasogen's current lack of access to capital, and the uncertainty surrounding the FDA's continued opposition to a relatively small trial utilizing a Bayesian statistical design, the Company has placed on hold plans to fund ACCLAIM II. The Company will, however, continue to work with the FDA towards finalizing the design of ACCLAIM II, and will evaluate potential strategic alternatives to fund such a study. In addition, subsequent to the recent receipt of a much lower than anticipated revenue forecast for Celacade from its European marketing partner, Grupo Ferrer, Vasogen plans to discontinue operational and financial support for European commercialization and is exploring alternative strategies with Ferrer. Ferrer's sales forecast was impacted by the uncertainty surrounding ACCLAIM II.
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