Clinical Trials Resource Center


December 8, 2003

Genzyme reported positive results from two phase I trials investigating an HIF-1alpha gene therapy for the treatment of critical limb ischemia. Results showed that Ad2/HIF-1alpha/VP16 was safe, with no treatment-related serious adverse events reported. The randomized, double-blind, placebo controlled study trial enrolled 28 subjects with advanced critical limb ischemia. Preliminary results were also reported from a companion open-label dose escalation trial. Three placebo subjects from the main trial received Ad2/HIF-1alpha/VP16, and 10 new subjects received Ad2/HIF-1alpha/VP16. Data showed that complete ulcer healing was observed in three of the five treated subjects, assessed at one year. Results were reported at the American Heart Association's annual meeting in Orlando.

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