The Institute of Chemical Biology and Fundamental Medicine of the Siberian Branch of the RAS, ICBFM SB RAS reported the successful completion of the first phase of clinical trials of the domestic antitumor drug VV-GMCSF-Lact. They confirmed the safety of the drug and its effectiveness in the fight against breast tumors. The drug was developed by the Institute, the Vector Center and Oncostar LLC.
The first phase included:
Single administration of the drug.
Repeated administration of the drug.
Four-fold administration of the maximum permissible dose with a weekly interval.
The studies confirmed the absence of toxicity and the presence of a positive therapeutic effect. Clinical trials of the drug began in Russia in 2022.
According to the study, 55% of patients with terminal breast cancer showed a decrease in tumor size and stabilization of the pathological process. Vladimir Rikhter, Head of the Laboratory of Biotechnology at the ICBFM SB RAS, confirmed the effectiveness of the drug and readiness to move on to the second phase of trials.
The drug was developed on the basis of a recombinant strain of the smallpox virus. The regions responsible for virulence were removed from the virus genome, and genes that enhance oncolytic activity were introduced. For the first time, a gene encoding a cancer cell killer protein was used.