well, then on our channel, watch a special report by alisa romanova, a clinical case of which drugs are being studied by russia against the backdrop of western restrictions, and at the end of the hour, weather 24 will tell why freezing rains form? so what will the december weather be like?

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western pharm companies have suspended clinical trials in russia what does this mean for the drug market for patient doctors? today? this is an absolutely panicky situation. so, first of all, we have, well, i don’t want to call it response measures, but measures that, if necessary, will make it possible to obtain virtually any drug that

is circulating somewhere on the world market in the future. some patients who are clearly in the study, and the drug has helped and for them e access to a clinical study early access to a new innovative medicines. on the general scale of the country. this is probably not so, and that is, no one will notice such developments russian pharmaceutical companies are building up in august, we received permission to conduct a clinical study in spinal muscular therapy, where children under 8 months old will also be actively implementing a program for neurostomy also in patients younger age groups and what original innovative research is being done right now. this is a new target on the market at today, and there are no drugs for this target, so the molecule is unique, and we are planning to launch this development not only in russia but also in the world.

at the world's largest gastrointestinal tumor symposium this summer in san francisco, the attention of many scientists was riveted on a tiny vial in a bottle of alphabet, the world's first targeted drug that specifically works against specific parts of cells in stomach tumors. such solutions were developed by two leading oncologists from russian professor sergei finlyan and oncologist ilya timofeev scientists selected molecules for 6 years until they received this final russian development, a historical inhibitor of fibroblast growth receptors. behind these pseudo-scientific words, the essence of the discovery is to hit right on target, when the patient is no longer helping in such drugs in the world . we found that this target is expressed on stomach cancer cells and on cancer and

ovarian cells, which are very common in russia, so the task was to come up with a drug which blocks this target, the innovativeness of this development lies in the fact that the drug binds to certain centers. in this receptor and changes it, the change of this receptor leads to the fact that the tumor cell of the stomach of gastric cancer is not activated and the tumor and metastases die from their start-up, with the support of the fund. skolkov, conducted preclinical studies and the first phase is already on people of the alphabet. administered to 21 russian patients with gastric cancer with multiple metastases, non-standard medicines. they didn’t help anymore, then some patients were severe, and in 68% of cases. we have achieved control over the disease, their tumor has ceased to develop these data, the oncologists presented at a congress in the united states, their report was chosen from the three most interesting for a special discussion. another

patient. six lines of therapy received, and the body stuffed on after only 2 months of the appointment of the alphabet. the metastases themselves began to shrink. here, in particular, by 24%, one large by 7%. and most importantly, this patient is from may 2021, alive until he currently, the alphabet has shown itself to be not very tactful ahead, the second phase of the study is already 150%. alafanib has been shown to work in patients who have already exhausted standard therapy. that is, essentially. these patients are candidates for hospice. the first results have allowed, e, to initiate a phase ii study where the alphabet will already be studied in patients with previously untreated who have not received. uh, medicinal treatment. this is also stomach cancer, the second indication is ovarian cancer, for which there are also very few drugs and little revolution data for this tumor. we decided to try to use the alphabet and learn it in patients

too, who can no longer receive standard care. the russian company pharm - this is its production and laboratory in the moscow technopark has acquired a license for the alphabet and, together with the developers of the drug, will conduct the second phase of studying research in oncology - this is basically the study of foreign drugs, and this year, for obvious reasons, there are fewer of them and less, and in this regard, as a domestic company, we try to maintain the level. ah and ah, we are taking more and more innovative developments into our portfolio. this is an innovative molecule, and one of the first in the class, and we have very high hopes for its development and release. in particular, in some foreign countries, the results of the first phase, they were also greatly inspired by the way the alphabet purposefully twists the receptor for tumor cells, the absence of strong side effects and, most importantly, how it helps to prolong life and with

center in the city of omsk and the patient received, a received, in my opinion, 14 courses of chemotherapy, a to a. the appointment of lufanib and e, the duration of therapy with this particular drug was 18 months. this is a colossal period, that is, during this period , the patient showed a positive trend. in the second phase, italian specialists will study the mechanisms of this drug. in the second phase , we already choose more specific doses based on the data of the first and e, carry out a preliminary assessment of the effectiveness. second phase. yes, this is probably the most, but the key moment when we can understand that the drug really works. we are located in the clinical research department of the endocrinological research center. every year there are about 30 clinical trials of various drugs that are studied in patients with various types of

endocrinopathy. this is the holy of holies of our department - premises for the storage of biological samples, which we receive as part of a study today at the leading federal endocrinological center there are about 200 volunteers in russia, those who agreed to test new drugs on themselves, when everyone is on drips, these are usually very early phases of the study and most often it is healthy and volunteers and when it comes to patients and real patients who participate in studies. this is, of course, an individual approach. russian and more often international studies have always taken place here, from 20 to 40 programs per year, all studies that have been started, where patients were included and treated continue, but probably since march or since april . in almost all new international studies, a set has been established. at first, these were logistical problems, and then it was simply decided to stop the recruitment in the center , they always tested innovative drugs and bio analogues of russian production, including new types of insulin. this sugar, 82,

how good it is now. how much time has passed after eating. an hour and a half hour and a half, it 's very good. world's first insulin injection was made exactly 100 years ago in russia today there are about five million people with confirmed diabetes. while there is improvement in favor. here are the technical means of managing diabetes, which facilitate this management. at the same time, it allows to achieve such a level of glucose so close to normal that life expectancy today is not limited, and complications do not develop at all. alexander lagutin was diagnosed with type 1 diabetes several years ago and participated in all possible clinical trials at the center endocrinology and russian and imported medicines. when, for example, these daily studies were. i campaigned online. well, people

with diabetes of the first type, well, guys, of course, because there only men could participate and a rather large percentage of people who came read the informed consent and understood that they did not want, that they were afraid of the ussr health. yeah well, because it's not a resort, actually, uh, lie down. uh, a day or even more on drips when you have every 5 minutes take blood from vienna for themselves decided to participate. this is an opportunity to get someday insulin, which you need to inject several times a day, and for example, once a week, and someday in the future become. perhaps one of the first to even be cured. the hope remains that some absolute cure will be found for this disease. even though yes, in principle, i would say that i live a full life. i don’t limit myself to anything, of course, i still remember my life when i didn’t have to count grams and carbohydrates in food and think about what high or

low sugars are at the moment in many westerners. no one will notice studies from russia on a countrywide scale, but if we are not talking about deadly diseases, and such a departure from the clinch of research from the market will affect, first of all, patients suffering from some kind of rare diseases or patients with oncological diseases, and who have today, there is very little choice of therapy, and for doctors, the result is an experience. this is again early access to new drugs drugs. this is participation in international cooperation. so i don’t think that the lack of research cuts us off for years from those drugs that pharma companies want to register in russia, well, this complicates the situation, we continue to send samples to the western laboratory, and we continue to have clinical trials that were started before february. and there are russian studies that will be processed in russia. in the first six months of 2022,

the ministry of health issued 425 permits for clinical trials, which is almost 30% more than in that the same period 2021 is noticeably smaller in the list of international projects. but much more local trend. e on the redistribution of the research market, the total number of e studies for the first half of this year, and even more than for e for the first half of last year, or the average according to statistics for 17 and 21 years. we are now talking about the statistics published by the association of clinical trial organizers, but in the second quarter the number of international clinical trials decreases, the number of local trials increases the number of russian equivalence studies is increasing. uh, that is, more. hmm, the relative share of russian. the share did not increase relative to international ones; it decreased in russia, foreign pharmaceutical companies. often, the last phases of research are carried out. they are already evaluating

effective dosages side effects and almost always these are drugs for the most dangerous diseases. what clinical trials mean for the patient we understand that these are often breakthrough innovative drugs in areas such as oncology and for patients. e recruitment into clinical trials means, sometimes it means saving a life, the association of patients in russia has already turned to western pharmaceutical companies. please return the study to the country. that is, you know this in some way for camouflage, but the refusal in the future to supply life-saving drugs to our country, so we consider the interests and rights of patients here to be very cool. e are violated, of course, the russian pharmaceutical industry is moving forward and there is, uh, a whole play, yes, of companies that work at the highest international level, but we must understand, uh, everything, uh, all niches are just physically, especially in a short time, foreign

companies will not be able to close, they stopped recruiting russian ones. there are certain conditions in order for the research to be validly recognized and its results not to be questioned. here are biomaterials according to these conditions. in the event of any validation, the audits must be delivered within there in various ways from 24 to 48 hours to the central laboratory. unfortunately, on the territory of the russian there was no federation of the central laboratory before these events. the more we talk to the companies, the more they say they would love to come back here. uh, either it will be open. e, the central laboratory on the territory of the russian federation, where we, respectively, will be able to withstand these guarantees, or the borders will be opened to russian standards, if at least one medical center did not participate in the research. in russia , the drug cannot receive state registration and be sold legally . medicines for arfan, that is, extremely rare

diseases. sechin university spoke about the fact that here we are. in the near future, we will lose 300 promising drugs that could come to us . i do not agree with this. well, apparently colleagues do not know our regulator very well, it will be able to get, but this is not within the framework of multicenter studies, but if any company wants to register this drug in the russian federation, then it comes here and conducts only in the russian federation without including foreign countries. uh, the pre-registration study is that there the russians will not participate in the study. yes, it's in the research phase. they get this drug, they get it for free, but this is a fairly small cohort, as a rule, out of the total number of cases, this does not mean absolutely that the drug will not come here. or vice versa, if the study was conducted here, then 100% that the drug will come here. vanovna from tomsk diagnosis

shogrin's syndrome appeared dryness in the organs in the mouth the skin was very dry and there was a problem in my eyes with vision. here, no matter how focused the vision and worked in the right institute and stopped. stopped working the way i was diagnosed before . in general, it's enough. soon , almost immediately, as far as i am aware, this disease is a fairly rare autoimmune rheumatological disease and therefore drugs that directly treat exactly uh. this disease is not his, viz. eh, the ones that soften. uh, symptoms at this center that

specializes in clinical research on innovative drugs. she got into the program is testing a new russian cure for her illness. uh, hmm, i actually had a mitigation of the symptoms of the disease. and now it treats my painful syndromes, i notice lately that it has become easier for me to go away, dryness and other symptoms, so i see what is good for me. that's it. this treatment e with a frequency of 2 weeks. uh, i, uh, i'm coming to the clinic. uh, a mandatory examination is carried out, a study is needed this time and an injection is given, and the next 2 weeks. i have already come to such a point that now i will leave myself hmm these injections at home

all drugs are given to me. she has been in the program for 2 years. this is an opportunity not only to help scientists, but also to get quick access to treatment herself and undergo free examinations. i hope to receive this medicine for a long time. there is a process of research going on. and then, if it passes, this is a test with positive results, it goes on sale, then i can also receive it, so i hope that my experience will help, and my positive results will help that it enters the market. this drug. i will be his the clinic was set up for the alzheimer's prevention and prevention project. volunteers received drugs and were followed up for 5 years. today, research is being conducted here in a variety of areas, neurology is very much not for the sake of generative diseases. uh, we took

part in clinical trials. and this cardiology, we had a number of protocols for prevention and cardiovascular complications, and we work in psychiatry. studies, including child psychiatry in the spring, enrollments in new western research have ceased here, but at the same time the trials started are continuing and, as the companies promise, they will be completed, when hmm began to be stopped, and new studies in russia. otherwise, current studies, well, at least in our center, they all continued part of the analyzes. we are now sending to russian laboratories. these are invitro and helix uh, since we have to evaluate rather quickly, yes, safety for patients, therefore, well, pharmaceutical companies, including global ones, and a number of them have made a decision, yes,

and we are now working with russian laboratories. at the same time, those samples that require a evaluation in the central laboratory. they continue to arrive at the central laboratory, despite any difficulties. petersburg pharmaceutical company biocad is known for its innovative developments. today, there are more and more studies of russian and breakthrough drugs and the number of ongoing clinical trials. we have increased if last year there were 23 active programs, in the twenty-second there are 37 and we plan to increase the number of ongoing at the same time, the company’s clinical trials issued permission to study original drugs developed in russia, including for the treatment of melanoma and other diseases, in august we received permission to conduct a clinical trial in spinal muscular therapy, where

children under eight months old will also -blastoma also in younger patients, and interesting is the study from our original and is not like any other drugs for treatment illness. ankylosing spondylitis is another name for spondyloarthritis and now recruitment for the second phase of the clinical trial is nearing completion. at first it was the usual pain in the back, then the injections of the blockade no longer helped victor's vomer, as is most often the case with ankylosing sponditis. she was diagnosed with ankylosing spondylitis at a young age, drugs bound by mobility. the only thing that improves and the disease is given in full radiation is only stopped. now he is in remission regularly. survey. at the institute of lymphology in novosibirsk, exactly. here more than 20 years deal with the problems of rheumatology disease. ankylosing spondylitis causing fusion of the vertebrae

has been successfully treated for all these years with genetic engineering preparations, but they are expensive and require special storage of the average course of treatment for patients with pectiro disease. gene engineering with biological preparations today in russia is from 400 to 800,000 rubles. in year. this is a serious burden on the budget. so here they thought about an alternative drug extremely widely distributed rheumatic disease it is generally accepted that approximately 0.2.06% of the world's population suffers from this disease. this is a colossal figure, then the average patient falls ill. approximately at the age of 20, for about 10 years, the disease manifests itself in the fact that his back hurts in the morning and does not pay attention to it. he believes that everyone will consider him some kind of simulator for agrants. and that's only when he can no longer get out of bed. he is starting to think about himself now go before a clinical study of the drug will be based on

optomers are small molecules that bind to target molecules and are targeted by the authors, these are synthesized artificial chemical synthesized. ah, short fragments of nucleic acids that are able to specifically bind a strictly defined target molecule, in our case, such a phene molecule is interleukin, 17, which, uh, triggers inflammation in spondyloarthritis. our task is to bind this molecule with the help of an optomer and place it to give a signal for inflammation. in this laboratory, the molecule synthesizes according to the investigations go to special hatched mice. the synthesized molecules showed that it is not toxic to laboratory animals and showed that in men in whom we specifically induced spondyloarthritis after the author's administration, the signs of the disease softened. that is, they increase mobility. they go better with

innovative drugs. after all you research. may be ready in 2030, the substance patients should be injected like diabetics. damn it all his life, so for him at the institute they are developing a gadget for injection and it would be as convenient as possible to create a special device, a, in which there would be a reservoir with a medicine, for example, an insulin pump or insulin pens, which can be with the patient for a long time . and at the same time, the drug does not deteriorate, does not lose its effectiveness, retains its usual activity. and uh, optomeric technologies allow us to assume that such a device can be created, research is still at the start, but collaborators. nikami demolishes to test the drug for safety the way from the molecule to the pharmaceutical the market for innovative drugs around the world takes years, even decades, but only in this way. step by step, scientists are working to ensure that in the future their

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