Russian drug against prostate cancer
Avionco Company starts clinical trials
the first Russian innovative drug for the treatment of prostate cancer
The research is carried out with the support of the Ministry of Industry and Trade of the Russian Federation within the framework of the Federal Target Program "Development of the pharmaceutical and medical industry of the Russian Federation for the period up to 2020 and beyond".
ONC1-0013B is a triple-acting androgen receptor antagonist. To date, drugs with such a mechanism of action are the most promising for the treatment of prostate cancer, including its castration-resistant forms. In a clinical study, the safety and tolerability of single and multiple doses of increasing doses will be studied and the maximum tolerated dose (MPD) of the drug ONC1-0013B will be determined in patients with progressive metastatic castration-resistant prostate cancer (CRPC). The pharmacokinetics will also be studied and the effect of the drug ONK1-0013B on the dynamics of the tumor process will be evaluated.
The partner for the organization and conduct of clinical trials ONK1-0013B was the company "IFARMA" – a contract research organization specializing in the early phases (Phase 1 and 2) of CI and occupying a leading position in the number of studies of innovative medicines in Russia.
Prostate cancer (prostate cancer) ranks first in prevalence among men in many countries and is one of the most pressing problems of modern oncology. In the early stages, the disease has no clinical symptoms and is detected during routine examinations by determining the level of PSA (prostate specific antigen). Sooner or later, prostate cancer turns into a castration-resistant form, the methods of treatment of which until recently were very limited. At the metastatic stage, prostate cancer is considered completely incurable, but recent developments can significantly prolong and improve the quality of life of the patient.
According to the data of the P.A. Herzen Moscow Research Oncological Institute, at the end of 2012, more than 134 thousand patients were registered with a diagnosis of prostate cancer in the Russian Federation, of which more than 27 thousand were diagnosed for the first time in their lives. According to the World Health Organization (WHO), more than 1.1 million new cases of prostate cancer (about 15% of all new malignancies among men) and more than 300 thousand deaths from prostate cancer were registered in the world in 2012.
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