Developers: | Biocad |
Last Release Date: | 2019/09/27 |
Branches: | Pharmaceutics, medicine, health care |
Domajor is the international multicenter randomized double blind placebo - controlled clinical trial 3 phases for efficiency evaluation and security of medicine with MNN prolgolimab in a combination with chemotherapy at patients with widespread not planocellular non-small cell cancer of easy (NMRL).
2019: Permission to carrying out clinical trial in Slovakia
On September 27, 2019 the biotechnology company BIOCAD reported that it got permission to carrying out clinical trial of original medicine of own development in one from the countries of the European Union. The company will be able to carry out clinical in Slovakia the medicine research DOMAJOR with MNN prolgolimab, intended for treatment non-small cell cancer of a lung. At this stage the company is going to invest in clinical trial necessary for a medicine output to the markets of China and countries European Union, more than 25 million euros.
Permission to performing the clinical trial (CT) in Slovakia became the first on territories of the European Union.
It is only small Slovakia so far, but we received confirmation
to that huge work on development of medicine according to the recommendations of ICH was not vain. I am sure that permissions to carrying out will soon follow KI of this Russian medicine and in other European Union countries, |
This clinical trial represents the international multicenter randomized, double-blind placebo - controlled comparative clinical phase research III in parallel groups which purpose is studying efficiency and security of a combination of medicines BCD-100, pemetreksed and tsisplatin/karboplatin in comparison with a combination of placebo and medicines pemetreksed and tsisplatin/karboplatin as the first line of therapy of patients with metastatic non-small cell not planocellular cancer of easy (NMRL). The hypothesis that use of medicine BCD-100 in a combination with chemotherapy is the cornerstone of a research promotes increase in the general survival in comparison with application of chemotherapy in combinations with placebo.
In a research it is going to include at least 292 patients who will be taken in the period of 12 months in the territory of the European Union, the Russian Federation, and Chinese People's republic. It is predicted that the following country of the European Union ready issue permission to carrying out KI, there will be Hungary. It is expected that it will occur already in October, 2019.