A drug for the treatment of cancers was approved in the USA

The FDA approved Vitrakvi (Loxo Oncology) in fast forward for the treatment of cancer in adults and children with a certain genetic mutation (biomarker). As noted by the FDA, this is a second drug approved for the treating of tumors regardless of their location.

Vitrakvi is intended for the treatment of adults and children with various neoplasms with mutations characterized by a fusion of the TRK gene and with the progressive disease after therapy. Such mutations are rare and located in many body parts.

The efficacy of the drug was studied in three clinical studies involving 55 patients with solid tumors and fusion of the TRK gene with metastases and those who didn’t have surgery, as well as patients with progressive disease after treatment.

According to the data obtained, the overall response rate was 75%. In 73% of patients, the response was maintained for at least six months, and in 39% – for one year or more. Among the tumors responded to the therapy are soft tissue sarcoma, salivary gland cancer, infantile fibrosarcoma, thyroid cancer, and lung cancer.

Side effects associated with taking Vitrakvi were: fatigue, nausea, cough, constipation, diarrhea, dizziness, vomiting, and increased levels of liver enzymes.

Link: www.labclinpharm.ru

Defeated virus: will the flu become a second smallpox?

With the arrival of the first colds, the number of cases of acute respiratory viral diseases increases, the most serious of which is considered the flu.

According to the World Health Organization (WHO), from 10 to 15% of the world’s population is infected with influenza viruses, which leads to death, including economically developed countries.

It is proven that vaccinal prevention is one of the most effective ways to fight the flu. According to experts, when vaccine and circulating strains occur, vaccination reduces the incidence of diseases in the population by 50-60%. The effectiveness of vaccine prevention of influenza is confirmed not only by clinical studies, but also by statistical data: from 1996-2017 vaccination coverage in Russia increased from 0.2% to 46.5%, which made it possible to reduce the incidence of influenza by 155 times and bring vaccination to the most important tasks. This year, an innovative drug which will allow us to solve the problem of the incidence of influenza appeared on the domestic pharmaceutical market in the Russian Federation.

In July 2018, Petrovax NPO Farm received a registration certificate for Grippol® Quadri, which is the first domestic tetravalent vaccine against influenza. Vaccination has already become available in this surveillance in 2018/2019, it is allowed to use from the age of 18, but clinical studies are currently being conducted on the efficacy and safety of its use in childhood.

According to leading experts in the field of infectious diseases, the results of clinical trials of the first domestic tetravalent vaccine showed that it is well tolerated, has a low-reactive vaccine and has a favorable safety profile. An assessment of immunogenicity has shown that tetravalent vaccination, which allows analysis of 5 ug of antigens of two types of virus and two viruses, does not provide trivalent reference vaccines for the control of strains and outperforms them in relation to the fourth strain, the influenza B virus, which is not included in trivalent viruses.

Currently, production vaccines are produced only in 6 countries of the world – Australia, Germany, Canada, New Zealand, the USA and France, this year in this honorary list the Russian Federation entered. New domestic vaccination is not inferior to high-quality foreign analogues, because It meets the requirements of GMP and has a number of pharmacoeconomic advantages. According to experts, its use will provide up to 265 thousand cases of flu for the season and save more than 2.5 billion rubles of state budget, compared with traditional trivalent vaccines.

Author: Elizaveta Mikitenko

Drugs for the treatment of multiple sclerosis are included in the List of drugs for the treatment of high-cost nosologies

In accordance with the Government Regulation of the Russian Federation No. 2738-p of 10 December, a drug product is included in the list of drugs for patients with hemophilia, cystic fibrosis, pituitary ganosis, painful Gaucher syndrome, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, as well as persons after transplantation of organs and/ or tissues.

“Multiple sclerosis is among the most common autoimmune diseases of central nervous system. The disease is mainly observed among young and fit-for-duty population at the age of 18-45 years, this disease quickly leads to disability. Our task is to prevent this process. This year the drug was included in the list of drugs for “high-cost nosology programs”, which allows us to expand the range of available treatment options for first-line multiple sclerosis therapy. A new therapy will allow you to control more effectively the incidence of the disease and reduce the risk of progression of disability by 38% 3. Katherina Pogodina, Managing Director of Janssen in Russia and the CIS, stated that the company made maximum efforts to achieve minimum price all over the world.

Plegridi belongs to the group of interferons. It is a necessary interferon beta-1a, which is derived from polyethylene glycol. It is used to treat adult patients with relapsing-remitting multiple sclerosis. PEGylation helps to increase molecule stability, reduces their immunogenicity, prolongs the effect, and also allows to reduce the frequency of administration – one Plegridi injection per two weeks.

The community of expert consultants considers the expansion of therapeutic options for multiple sclerosis within the framework of the federal“ High-Cost Nosology Program” to be a significant breakthrough. PEGylated interferon allows to reduce the frequency of injections for the patient by 6 times. “Obviously, the therapy can increase patient’s compliance, which makes it possible to achieve greater success in treating consuming the same or less resources, ” Yan Vladimirovich Vlasov, President of the All-Russian Public Organization of Multiple Sclerosis Patients and Disabled, said.

Link: www.vidal.ru

In the United States clinical trial Russia’s drug Vizomitin were launched

The university project “Ions of Skulachev” and “Mitotech” reported that Phase III clinical trial of ophthalmic drug Vizomitin had been launched in the United States. It was among the drugs that could reach the final phase of research in the United States. If the studies are successful, Vizomitin can be registered by the FDA.

The active ingredient of the drug is the mitochondria-targeted antioxidant SkQ1, which is able to penetrate into the mitochondria of living cells and protect them from oxidative damage. As a result, the drug has a mild anti-inflammatory effect and accelerates tissue regeneration.

About 500 patients with dry eye syndrome will take part in the multicenter study. The main task of the study is to confirm the previously obtained data that SkQ1 accelerates the healing of corneal injuries occuring at dry eye syndrome, as well as eliminates the clinical manifestations of the disease and increases the resistance of the eyes to dry air.

The latter parameter will be estimated with the special system Ora CAE® (controlled unfavorable environment). Its use allows to simulate the stress conditions in a standardized way where a patient with “dry eye syndrome” periodically falls.

According to Maxim Skulachev, the CEO of Mitotech, the results of a clinical trial will be obtained in the latter half of 2019. “Thus, the first Russian medicine can be launched on the US market already in 2020-2021,” he said.

Link: www.remedium.ru

Janssen and Merck co-finance the creation of an innovation center for the production of vaccines in the UK

The UK government is preparing for possible outbreaks of dangerous diseases after Brexit Therefore, with the support of academic institutions and pharmaceutical companies it is creating the first innovative vaccine production center in the country, as reported by FiercePharma.

The total funding for the project is about $100 million, from which £ 66 million ($ 84 million) will be invested through public-private partnership UK Research and Innovation. Other £10 million will come from Janssen (Janssen), Merck & Co. (Merck & Co.); known as Merck Sharp & Dohme (Merck, Sharp & Dome) in the UK, and the Wellcome Trust, a charitable foundation for biomedical research.

The center, which will be based in Oxford, is scheduled to launch in 2022. It is planned that the center will focus on creating operational and cost-effective ways to develop and produce vaccines for clinical research and global distribution, as well as to create stocks of vaccines in the country in the event of a pandemic .

The center specialists will also develop new technologies, for example, to create personalized cancer vaccines and vectors for gen-therapeutic drugs.

Link: pharmvestnik.ru

BRIEF OVERVIEW OF CLINICAL RESEARCHES OF ANTI-CANCER ACTIVITY OF ARTEMISININ DERIVATIVES

Artemisinin is a sesquiterpene lactone isolated from the aerial part of sweet wormwood in the 1970s. It is the base for one of the most effective medicines for the treatment of malaria and is widely used. Over the past two decades many in vitro and in vivo studies have been conducted with artemisinin. They detected the anticancer properties of this drug in relation to some cancer cell lines.

The aim of the study was to review the scientific information on the study of clinical cases and the results of clinical trials with the use of drugs based on artemisinin derivatives.
The study used information retrieval and library databases, as well as ResearchGate applications for semantic search.
During the study, it was found that most of the known clinical cases and performed clinical studies are associated with the study of the anticancer properties of one of the artemisinin derivatives – artesunate.
The data obtained by various research groups at the moment does not allow us to speak to the pronounced properties of the latter. However, the facts of extending the life of patients, improving its quality, and increasing control over the disease have been established.

It can be concluded that the published data of clinical cases and clinical studies conducted from 2001 to 2016 instill restrained optimism associated with the prospect of using drugs based on artemisinin in oncology.

Read more www.pharmpharm.ru

The evolution of breast cancer therapy: an expert view

On November 2018 at XXII Russian Oncological Congress Professor Dennis Slamon, the Head of the Department of Hematology and Oncology of the University of California in Los Angeles and founder of targeted cancer therapy, made a speech. In his speech he talked about the development of modern approaches to the treatment of breast cancer (BC) including the most important discoveries in this area.

Dennis Slamon noted that breast cancer is one of the most common cancers in women. In the United States alone more than 200 thousand breast cancer patients and over 39 thousand deaths are registered every year.

For a long period breast cancer was treated with traditional methods of chemotherapy, while the outcomes in patients varied significantly. The situation was changed after it was realized that breast cancer is a spectrum of diseases, the most aggressive forms are associated with overexpression of human epidermal growth factor receptor 2 (HER-2). This type of cancer, called HER 2-positive, is detected in 20-25% of patients with breast cancer and is one of the least favorable forms of the disease.

The discovery made by prof. Slamon led to the creation of a monoclonal antibody that inhibit the HER-2 receptor, and made it possible to completely change the fate of a huge number of women. Today HER 2 positive breast cancer is treatable with adjuvant therapy in patients.

Currently, patients with HER2-positive breast cancer have the most favorable prognosis of the disease. All over the world 3 million of breast cancer patients have already been treated.

The scientist also raised the issue of therapy for patients with HER 2-negative hormone-positive breast cancer, and mentioned that these tumors are up to 65% of all breast cancers. For the treatment of such patients hormonal anticancer drugs are used, but the therapy doesn’t always lead to the expected result. In order to solve this problem in 2009 under the guidance of prof. Slamon scientists began to research cyclin-dependent kinases (CDK), a group of proteins that play a leading role in regulating the cell cycle. As a result CDK inhibitors have been developed. But the CDK inhibitors were broad-spectrum drugs, their use was accompanied by severe toxicity.

The answer was the creation of a selective inhibitor of CDK 4/6 (cyclin-dependent kinases 4 and 6). Already the first clinical trial involved 12 patients showed that the drug inhibited tumor growth until its complete disappearance. The level of white blood cells in patients did not decrease, the patients did not go bald, none of them complained of nausea. A larger clinical trial where 165 women participated showed while taking CDK 4/6, the period of tumor control increased by 2 times: from 10 to 20 months. The cases of complete cure were recorded. According to the international multicenter CT where 660 women participated including Russian patients, the new drug was approved and brought to the market. Today several drugs of this group are registered in the world, including two drugs registered in Russia.

Link: www.remedium.ru

Clinical trials of a whole range of anti-Ebola drugs will be held in Congo

The Congo authorities approved four clinical trials to combat with Ebola. Researches help to collect the necessary data to evaluate the effectiveness of medicines.

Since 1975, 10 outbreaks of Ebola have been recorded in the Congo, the last one was identified this year as the largest of the hole observation period. Congolese doctors have been using experimental drugs in clinical practice since August to fight a fever. Now, their use will be regulated by the study protocol.

All four experimental drugs are monoclonal antibodies mAb114, they are similar in structure to antibodies to the Ebola virus, obtained from the blood of an African who has had this infection.

Cases of Ebola were recorded in the Congo province of North Kivu since April of this year. In the summer, the situation worsened after the infection was brought to the neighboring province of Ituri. In this area, the elimination of the outbreak is hampered by the ongoing clashes between local militias.

Link: www.remedium.ru

The European Commission approved Emgality for migraine prevention

The European Commission approved the use of monoclonal antibody Emgality (galcanezumab) for injection one time per month for migraine prevention in adults who suffered from migraines attacks at least four times per month as PharmaTimes reported.

One month ago the FDA also approved the use of the drug in this indication in the same patient population.
Emgality developed specifically for migraine prevention blocks calcitonin gene-related peptide (CGRP) receptor associated with migraine attacks and also reduces the rate of migraine attacks per month.

According to three clinical studies (EVOLVE-1, EVOLVE-2, and REGAIN) where 2 901 subjects participated, the group received Emgality experienced a significant decrease in MHD compared to the placebo group.

In EVOLVE-1 and EVOLVE-2, more than 1/3 of subjects achieved MHD decrease by at least 75% compared to 19.3% and 17.8%, respectively, in the placebo group.

Migraine occupies the third place in the world in the list of the most common diseases and takes the leading position among neurological diseases causing disability.

Link: pharmvestnik.ru

High doses of B vitamins as a means of symptomatic and pathogenetic therapy

Since the middle of the 20th century many doctors began to consider  high doses of B vitamins as a symptomatic and pathogenetic therapy.

B vitamins are neurotropic. They significantly influence on the processes in the nervous system, for example, metabolism, metabolism of mediators, or transmission of excitation.

Vitamin B1 (thiamine) is involved in nerve impulse conduction; it also provides axonal transport that influences on the regeneration of nervous tissue, modulates the neuromuscular transmission, as well as regulates the excitation of the nerve.

Vitamin B6 (pyrodoxine) is a co-factor for over 100 enzymes. It influences on the structure and function of the nervous tissue and firstly regulates the metabolism of amino acids, thereby ensuring the normalization of protein metabolism; this vitamin also participates in the synthesis of various mediators.

Vitamin B12 is involved in the synthesis of the myelin sheath of the axons of nerve cells. It reduces pain when a peripheral nervous system is damaged.

Combination of high-dose B vitamins in the treatment of acute back pain is safe and effective, as it is confirmed by clinical trials.

In experimental models, the combination of high doses of thiamine, pyridoxine and cyanocobalamin was shown to be able to inhibit the passage of pain impulses at the level of the posterior horns and thalamus, to enhance the effect of norepinephrine and serotonin, and to promote the regeneration of nerve fibers.

There is an assumption that the combination of В vitamins inhibits the synthesis and / or blocks the action of inflammatory mediators.

Link: www.medlinks.ru