25.09.2019 News

Biocad received a clinical trial authorization for its original medicinal product in the EU

The company starts the clinical trial “DOMAJOR” in Slovakia of the drug prolgolimab in treatment of non small cell lung cancer. The company intends to invest over 25 million euro in this clinical development and launch the product in China and the EU. 

DOMAJOR is a phase lll, international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of a drug with INN prolgolimab in combination with chemotherapy in patients with advanced non-squamous non-small cell lung cancer (NSCLC)  

The authorization to conduct the clinical trial in Slovakia was the first in the EU. “So far, it’s only Slovakia, but we have received a first confirmation that the huge work on the development of the drug in accordance with ICH recommendations was not in vain. I’m sure that soon the authorization to conduct CI of this Russian drug in other EU countries will follow.” said Roman Ivanov, Vice President for Development and Research at Biocad.  

This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, comparative clinical trial of phase III in parallel groups. The main purpose is to study the efficacy and safety of the combination of prolgolimab (BCD-100), pemetrexed and cisplatin / carboplatin in comparison with the combination of placebo and pemetrexed and cisplatin / carboplatin at the first line of treatment for patients with metastatic non-small cell non-squamous cell lung cancer (NSCLC). The study is based on the hypothesis that the use of prolgolimab in combination with chemotherapy increases overall survival compared to chemotherapy in combination with placebo. 

292 patients will be recruited in the Study within a period of 12 months in the European Union, the Russian Federation, and the People's Republic of China. It is predicted that Hungary will become the next country in the European Union ready to issue the authorization to conduct this clinical trial already in October.