Modern medicine is impossible without innovation drugs. Unfortunately, our pharmacological industry lags behind the world production. As a rule, we produce the long known Russian or far from new preparations, replicas of the foreign ones--the so-called generics. On the other hand, rather many perspective drugs have been developed by Russian pharmacologists, but due to lack of proper financing and multistage registration procedure, taking from 3 to 5 years, it becomes difficult to start their production. The Federal Target Program "Development of Pharmaceutical and Medical Industry in the Russian Federation for the Period of up to 2020 and Further Prospects" (Phar-ma-2020), approved in 2008, is expected to improve the situation. Its main goal is to improve internal and external competitiveness of our industry, which should lead to better national drug supply to the population and public health institutions. Pharma-2020 implies changes not only in quantitative, but also in qualitative characteristics at the expense of a significant increase in the share of innovation preparations (up to 60 percent of total output), containing an active substance, original by structure and mechanism of action, affecting the concrete biological target. The G5 drug, making human brain to produce stem cells, essential for restoration of sick organs, recently presented by scientists of Tomsk Institute of Pharmacology, Siberian Branch of the Russian Academy of Medical Sciences, and SFM-Pharma company, Novosibirsk, is one from this list of innovation drugs. The teams of scientists creating G5 are headed by
Academician Alexander Dygai (Tomsk) and Andrei Bekarev (Novosibirsk), who speak about approaches to the development of a new class of 21st century drugs in the Medicinarf information portal and RIA Novosti.
Dygai says that the use of stem cells has first attracted the interest of scientists about 15 years ago, and now it is one of the most popular trends in medical science all over the world. The therapeutic potential of this biological material is extremely high: it can be used for the treatment of a great many diseases, from cancer or liver diseases to cosmetic corrections. However, not all modern therapeutic methods, for example, injections of stem cells, multiplied outside the organism, are acknowledged to be effective. Moreover, they are fraught with certain risks, such as histocompatibility, rejection reactions, or malignant transformation of tissues. Specialists of the Institute of Pharmacology have chosen a different approach: they have found a method for sufficiently rapid regeneration of rescue cells in the body, specifically, in human brain.
Dygai states that the Tomsk medical school has been engaged in these studies for at least the past 3-4 decades. The studies were initiated by Member of the Russian Academy of Medical Sciences Evgeny Goldberg, while his students have become almost the first experimenters in regenerative medicine. Studies of the behavior of endogenous stem cells in various experimental diseases (diabetes mellitus, chronic hepatites, encephalopathies, destructive changes in the lungs) have shown that these cells made but a little contribution to regeneration of the viscera. They certainly reacted, but insufficiently for stimulation of regenerative processes. The age is a factor augmenting the problem: the older the patient--the more rapidly are his reserves of "repair" material vanishing. How can these processes be modified? By drugs stimulating release of one's own stem cells, capable of restoring the involved organs and tissues, the Tomsk scientists assert.
Dygai emphasized, "We stimulate release of stem cells from the so-called depot organs. They migrate through peripheral blood to the affected organ--liver, brain, pancreas, lungs, where they are differentiated and restore the organ function." By stimulating their release (by about 40 percent) and functional activity, it is possible to
attain stable remission and even recovery from many heretofore incurable diseases.
This is the mechanism of action of G5, one of the first in the world drugs for regenerative medicine. By the present time the Institute of Pharmacology and its partners from SFM-Pharma are almost through with its preclinical trials on animals. The first results are quite optimistic. For example, recovery of mice with toxic cirrhosis of the liver has been attained. As a rule, nothing but the organ transplantation helps in a neglected process. Experimental mice with initial cirrhosis have been completely cured. In other words, G5 restored the liver--the parenchyma and stroma.
No less interesting are the results of the drug testing for embryotoxicity. Mice received a high dose of the drug, after which they were transplanted fertilized ovi-cells, and the surviving ovicells were then counted. Almost 100 percent ovicells developed and the animals from them reached a mature age. Repeated experiments confirmed these results. Hence, in the future G5 should be studied as a drug for reproductive function treatment.
Another experiment of Siberian scientists also became a sensation, informed the RIA Novosti. By the results of this experiment, the experts called G5 an "anti-aging pill". Bekarev described the experiment: 12-month-old rodents were divided into control and experimental groups. Experimental animals received the drug orally. A significant difference between the two groups was obvious at the age of 18 months. More than 30 percent controls died of old age; all mice developed signs of aging: alopecia, tarsus arthritis, body weight loss, changes in blood biochemistry. By contrast, experimental mice had twice bigger body weight and had no signs of aging, while blood biochemistry corresponded to that of a normal mouse. The experiment was completed after the mice reached the age of 20 months.
However, the scientists claim that the spectrum of the drug effects is more extensive. It can be used for the treatment of nervous system diseases, for example, encephalopathy (brain disease). The use of the drug leads to complete recovery of cognitive functions. Pharmacologists think that G5 can be used in therapy of diabetes mellitus and destructive diseases of the lungs. But a detailed study of these therapeutic effects is still ahead.
The authors have chosen just one indicator for registration: therapy for cirrhosis of the liver. Bekarev has explained that in this case the drug would be sooner released onto the drug market. Preclinical trials will be over in November 2013, and the files will then be sent to the Ministry of Health. After permission will be granted by the Ministry, clinical trials will start.
The drug will be manufactured by SFM-Pharma--the first resident of the scientific and technological park in the biotechnology sphere of the Koltsovo science center near Novosibirsk. The manufacture of this class of preparations is a complex and expensive business. In the Western countries only the rich people can afford drugs of this level. In Russia a nanostructurized drug will be produced by a rather economic method, developed at the Institute of Pharmacology--by electron radiosynthe-sis. The industrial expenditures are several times lower, while the efficiency is high.
The SFM-Pharma has a modern industrial base. Several years ago two industrial constructions for laboratories and a sterilization center with two electron radioac-celerators have been built. One of them is medical; it will be used for the production of G5.
According to Bekarev, the drug will appear in the market in the form of tablets or capsules. It is expected that clinical trials will take a year and a half or maybe two years. The price of the drug will directly depend on the volume of its production. According to preliminary estimations, the future preparation will be inexpensive in comparison with foreign analogs of this class.
Siberian Scientists Tried Anti-Aging Tablets on Themselves.--RIA Novosti, March 30, 2013
Illustrations from Internet sources
Prepared by Marina KHALIZEVA
Опубликовано на Порталусе 09 ноября 2021 года
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