Skulachev's ions have reached America
Clinical trials of a drug developed in Russia have begun in the USA
Information about the study can be found in the official clinical research database of the US National Institutes of Health: A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome.
SkQ1 is a substance that has the ability to selectively accumulate in mitochondria, reducing the level of free radicals produced by these cellular organelles. Compounds of this type were first synthesized and used for research purposes by Vladimir Skulachev in the 60s of the last century and were called "Skulachev ions". Preclinical and clinical studies of the properties of SkQ1 and a number of other compounds have been conducted for several years on the basis of Lomonosov Moscow State University.
According to the developers, in order to obtain permission for clinical trials of SkQ1 in the United States, most laboratory studies of this compound were reproduced in independent American scientific institutions.
Thus, the safety and efficacy of the compound in animal experiments has been confirmed according to the standards of the US Food and Drug Administration (FDA).
The recruitment of participants in a double-blind placebo-controlled trial, which will involve more than 100 people, is currently being conducted by one of the ophthalmology clinics in Massachusetts. The SkQ1 drug in the form of eye drops will be examined in two dosages. The study is expected to be completed during 2014.
Read more about the design of SkQ1 clinical trials in the USA in an interview with Maxim Skulachev: Our task is to fight aging.
"According to our data, this is the first time that a substance entirely invented, studied and researched in Russia was allowed to be tested on Americans. American regulatory authorities are traditionally extremely wary of any medicines created outside the United States, so the fact that the FDA allowed the study is an outstanding event for the domestic pharmaceutical industry," Maxim Skulachev, deputy scientific director of the project, told Mednovosti.
The drug based on SkQ1 "Visomitin" is approved for use in the territory of the Russian Federation for the treatment of dry eye syndrome according to the results of clinical trials conducted in our country. Currently, several studies are being conducted in Russia and abroad to assess the potential of eye drops with SkQ1 in the treatment of cataracts and glaucoma. Studies of the oral form of the drug as a means of anti-aging therapy are also planned.
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