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October 5, 2014
AnGes Begins Global Phase III Clinical Trial of Collategene for CLI
October 6, 2014—AnGes MG, Inc. announced that it has commenced the global phase III clinical trial of Collategene for the treatment of patients with critical limb ischemia (CLI). The study’s first patient was enrolled in the United States and began screening, which evaluates whether a patient matches the eligibility of the clinical study protocol. Enrollment and treatment of subsequent patients will now commence.
According to the company, the phase III, double-blind, randomized, placebo-controlled study will evaluate the safety and efficacy of Collategene in approximately 500 patients with CLI. Collategene is a plasmid DNA-encoding human hepatocyte growth factor gene that is injected into the patient’s muscle to form new blood vessels and improve blood flow to the affected limb.
Data will be collected for application to the United States and European regulatory authorities. The trials will be conducted in North America, Europe, and South America (15 countries excluding Japan) over a period of approximately 3 years (from the first patient enrollment to the end of last patient visit), and submission of the Biologics License Application is targeted for as early as 2018 in the United States, with applications in Europe to follow, advised the company.
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