23 May 2019

The first Russian targeted drug

Skolkovo resident begins clinical trial of the first Russian targeted drug in oncology

Vitaly Shustikov, sk.ru

The Ministry of Health of the Russian Federation has issued a permit to conduct a clinical study of the safety and preliminary efficacy of alofanib, the first Russian targeted drug. Stomach cancer patients who have exhausted all standard methods of treatment will take part in the trials.

The developer of alofanib is the Russian company "Russian Pharmaceutical Technologies" ("Rusfarmtech", St. Petersburg). The innovative drug was created with the support of the Skolkovo Foundation.

Alofanib is the world's first allosteric inhibitor of the fibroblast growth factor receptor (FGFR2). Cancer cells of many tumors, including stomach cancer, contain FGFR2 on their surface. When the receptor is activated, cell division occurs, tumor growth and the spread of metastases. Unlike existing inhibitors that "work" inside the cell, alofanib blocks the part of the receptor that is located outside and "twists" it, preventing activation. As a result, the tumor cell does not divide.

This mechanism of action has been recognized as innovative and patented by Rusfarmtech in Russia, the EAEU countries, the USA, the European Union, Japan and China.

Preclinical results published in the well-known international journals European Journal of Cancer, Medicinal Chemistry and Investigative New Drugs indicate the need for further study of the drug. Currently, an expanded phase 1b clinical trial is being launched in patients with metastatic gastric cancer who have not been helped by standard treatment methods. The study will be conducted in Moscow, St. Petersburg, Omsk and Rostov-on-Don. 

Sergey Tyulyandin, Chairman of the Russian Society of Clinical Oncology: "Stomach cancer is an urgent medical and social problem in Russia. Traditionally, in the structure of morbidity, this tumor occupies the 4th and 6th place in men and women, respectively. More than 37 thousand new cases of stomach cancer are detected every year. Unfortunately, when metastases appear, treatment options are extremely limited and the life expectancy of these patients is about a year."

Kirill Kayem, Senior Vice President for Innovation of the Skolkovo Foundation:"The development of targeted drugs that purposefully affect the target in the tumor is supported by the Skolkovo Foundation. The emergence of new classes of inhibitors can lead to drastic changes and affect the life expectancy of patients, which is now observed in lung cancer, breast cancer, kidney cancer and other tumors. The first Russian targeted drug alofanib has successfully completed a cycle of extended preclinical studies in accordance with international requirements and will be studied at the first stage in patients with stomach cancer. The Grant Committee of the Skolkovo Foundation has decided to further support the project.

A press conference organized by the Skolkovo Foundation and the Russian Society of Clinical Oncology will be dedicated to the beginning of the clinical trial of alofanib.

The press conference is attended by:

  • Kirill Kayem, Senior Vice President for Innovation, Skolkovo Foundation;
  • Sergey Tyulyandin, Chairman of the Russian Society of Clinical Oncology (RUSSCO), Deputy Director for Research, Head of the Department of Clinical Pharmacology and Chemotherapy of the Blokhin National Research Medical Center of Oncology of the Ministry of Health of Russia, Doctor of Medical Sciences, Professor;
  • Ilya Timofeev, researcher of the alofanib program, Executive Director of the Russian Society of Clinical Oncology (RUSSCO).

The press conference will take place on May 28 at 12:00 in the Press Center of the Interfax News Agency at the address: 1st Tverskaya-Yamskaya str., 2, p. 1, 2nd floor.

Accreditation:
Sergey Sidorov
Press Secretary of the Russian Society of Clinical Oncology (RUSSCO)
Bodys: +7 (916) 637-86-85
E-mail: pr@russco.org

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