Date: 2016-01-21
Type of information: Clinical trial autorization
phase: 3
Announcement: clinical trial authorization
Company: Philogen (Italy)
Product: darleukin (L19- IL2) and fibromun (L19-TNF?)
Action
mechanism: monoclonal antibody
Disease: melanoma
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On January 21, 2016, Philogen announced the launch of a pivotal trial inpatients with Stage IIIB/C melanoma. During the month of December 2015, the Competent Authorities of Italy and of Germany have authorized the conduct of an international multi-center controlled Phase III pivotal clinical trial. The study will feature initially the participation of 15 leading European Dermato-Oncology Clinical Centers. In a recently published Phase II clinical trial, the Philogen group and collaborating Clinical Centers have demonstrated that the intratumoral injection of a combination of two immunocytokines (L19- IL2 and L19-TNF?) is able to substantially reduce or eradicate injected melanoma lesions, with durable responses and excellent cosmetic results. In addition, there was evidence of systemic bystander effects on non-injected lesions, indicating the onset of a protective anti-cancer immunity [Danielli et al. (2015)]. These data reinforce the findings of a previous Phase II clinical trial [Weide et al. (2014)] and of extensive preclinical investigations [Schwager et al. (2013); Pretto et al. (2014)].
