MOSCOW, March 1. /TASS/. Russia’s Federal Medical Biological Agency (FMBA) plans to complete phase one clinical trials of the Mir-19 coronavirus medicine in mid-March, the agency’s head Veronika Skvortsova said at a meeting with Russian President Vladimir Putin on Monday.
"We received permission to conduct clinical trials on December 30. All pre-clinical trials are over. Clinical trials began soon after the New Year. However, since it is a new molecule - it’s patented and unparalleled - we are conducting phase one trials particularly carefully because we need to prove that it’s safe for humans. We will complete phase one by mid-March. We are about to start working with patients and launch phase two," she said.
According to Skvortsova, the medication is based on micro-RNA that blocks certain parts of the virus RNA. "Micro-RNA is completely safe for humans, it affects neither the human genome nor immunity but is highly effective in targeting the virus. Experiments on animals showed that virus carriage was reduced 10,000-fold," she emphasized. "In addition, it prevents the most severe forms of the disease," the FMBA chief added.
Skvortsova explained that clinical trials of the coronavirus vaccine developed by the Federal Medical Biological Agency will begin in July. "We now have a candidate medication and preparations for clinical trials are underway. We do hope that we will be able to launch clinical trials by the second half of the year."
She also said that phase one and two trials would be conducted simultaneously because it was permitted by vaccine trial protocols.
According to Skvortsova, cellular immunity created by the vaccine was expected to last 13 to 17 years. "Antibody immunity usually lasts for months, while cellular immunity lasts for years, and certain experiments have proved that it lasts 13 to 17 years," the FMBA chief emphasized.