26 September 2016

Russian drug against melanoma

The first patient in Russia is included in the clinical trials of a revolutionary drug for skin cancer

Alena Zevyakina, Planet-today

Clinical trials of the revolutionary drug BCD-100, created by specialists of the Russian company BIOCAD, have started.

The costs for the early stages of development alone amounted to more than 100 million rubles, according to a press release received by the Planet Today editorial office. The results of preclinical studies conducted on animals proved the effectiveness of the new drug in the treatment of the most aggressive cancer disease – melanoma. In our country, this pathology leads to death in 80% of cases. However, the tests of a new generation of drugs allow us to give hope for a cure not to 20% of patients, as before, but to twice as many patients. The peculiarity of this development is the targeted destruction of cancer cells by the body's own immune system without damaging healthy tissues.

There are only two drugs with a similar mechanism of action in the world, but they are not registered in Russia and therefore are not available. In the treatment of inoperable forms of melanoma, modern oncology uses mainly chemotherapy, which allows to delay the growth of metastases only in 10-20% of cases. The majority of patients with metastatic stages of this disease, in fact, sign a death sentence. Moreover, according to the specialists of the Moscow State Medical University "P. A. Herzen Moscow Research Oncological Institute", in Russia patients with severe melanoma (III-IV stages) at the time of diagnosis - 23.8%, while in Europe, the USA and Australia there are no more than 13% of the total number of patients with a similar oncological pathology.

The introduction into clinical practice of the BCD-100, created by the biotech company BIOCAD, means the entry of Russian medicine to a fundamentally new level of treatment of metastatic melanoma and other types of cancerous tumors.

"This innovative drug is designed to help the patient's immune system control the tumor process, which means to increase the duration and improve the quality of life of patients with metastatic malignant neoplasms," says Roman Ivanov, Vice President of Development and Research at BIOCAD. - Preclinical trials of the drug BCD-100 based on a monoclonal antibody to the PD-1 antigen have been carried out for more than a year and a half, and we started developing it in 2013. What is PD-1? This is a protein on the surface of T-lymphocytes, with which cells of many types of malignant tumors interact, which allows them to "hide" from the attack of the human immune system. By blocking the PD-1 antigen with a monoclonal antibody, we restore the body's ability to recognize and destroy cancer cells."

Melanoma is not the only oncological pathology against which the drug BCD–100 is potentially effective. According to experts, it is able to provide positive results in the treatment of lung cancer, kidney, and other localizations. Moreover, the BCD-100 is not only not inferior to foreign analogues, but in many ways it surpasses them. Firstly, there are no amino acid sequences of animal origin in the preparation created by BIOCAD, which guarantees greater safety for humans. Secondly, it needs to be administered less often than imported drugs with a similar effect. And most importantly, the biological activity of the Russian BCD-100 is higher than foreign analogues, so experts consider its therapeutic potential to be higher.

The trials that have begun will be conducted on patients with common forms of malignant neoplasms of various localizations. The immediate task of the researchers is to confirm the safety of various doses of the drug monoclonal antibody to PD–1 in clinical conditions.

The success of the first stage of clinical trials will allow the BIOCAD team of specialists to begin solving the following tasks and to begin research on the effectiveness and safety of the drug in patients with certain types of malignant tumors. Its launch into production is scheduled for 2018, and it is the Russians who will be the first to get access to the revolutionary medicine.

Meanwhile, the laboratories of the biotech company BIOCAD are continuing to develop a number of other drugs based on monoclonal antibodies, which will be used in combination with BCD-100 and should multiply enhance its therapeutic effect.

Portal "Eternal youth" http://vechnayamolodost.ru  26.09.2016

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