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Date: 2010-03-05
Phase: II
Anouncement: Launch
Biotech: Mologen (Germany)
Pharma:
Product: MGN1703 (cancer immunotherapy based on dSLIM® immunomodulator, which is an agonist of the Toll-like receptor 9 involved in innate immunity)
Disease: metastatic colorectal cancer
Country: Germany, Austria, Great Britain, Russia, and other countries
Other: Mologen has received approval from the competent German and Austrian health authorities at the Paul Ehrlich Institute and the Federal Office for Safety in HealthCare respectively, to conduct a phase 2 study on MGN1703.
This phase 2 study will now investigate the efficacy of the drug in the treatment of metastatic colorectal cancer.
Additional study centers shall begin enrollment in Great Britain, Russia, and other countries as soon as the conduct of the study has been approved there.
The phase 2, randomized, placebo-controlled, double-blind, multicenter clinical study (IMPACT study) is designed as a licensing relevant confirmatory study and is intended to verify the efficacy of MGN1703 with statistical significance.
The primary objective of the study is to determine progression-free survival among patients with advanced colorectalcancer. Secondary study objectives include determining the overall survival of patients and collecting data on immunological and
pharmacodynamic parameters.
The study could have an overall duration of up to three years.