Date: 2014-10-06
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Anges MG (Japan)
Product: Collategene® (beperminogene perplasmid)
Action
mechanism: Collategene®, a plasmid DNA encoding human Hepatocyte Growth Factor (HGF) gene is considered to form new blood vessels and improve blood flow to the affected limb.
Disease: critical limb ischemia
Therapeutic area: Cardiovascular diseases
Country:
Trial details:
Latest
news: * On October 6, 2014, AnGes MG announced that it has commenced the global phase III clinical trials of Collategene® with the enrollment of patients in the US. The first patient was enrolled in the study on October 3, 2014 and began screening. Enrollment and treatment of subsequent patients will now commence. The Phase III double-blind, randomized, placebo-controlled study will evaluate the safety and efficacy of Collategene® in approximately 500 subjects with critical limb ischemia. Data will be collected for application to the US and European authorities. The trials will be conducted in North America, Europe, and South America (15 countries excluding Japan) over a period of approximately three 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 US, with applications in Europe to follow.
