In the Nikolai Blokhin Russian Cancer Research Center of the Russian Academy of Medical Sciences, a report on postmarketing clinical study of REFNOT titled “The effect of REFNOT on the immunity in cancer patients” was prepared. The study included 55 patients with different solid tumors in disseminated stage of the disease. The oncologists of the Russian Academy of Medical Sciences recommend using REFNOT as an immunomodulator either solely or combined with cytostatic drugs in patients with malignant tumors.
The reason for conducting a research of REFNOT titled “The effect of REFNOT on the immunityin cancer patients” was the decision to extend the list of its proposed indications.
Research objectives: to study clinical immunological effects of REFNOT in monotherapy of solid tumors and in combination with chemotherapy; to characterize the immunity markers and the level of cytokines during application of REFNOT in monotherapy of solid tumors and in combination with chemotherapy.
The studywas conducted in the Nikolai Blokhin Russian Cancer Research Center of the Russian Academy of Medical Sciences, the principal investigator is the deputy research director of the Nikolai Blokhin Russian Cancer Research Center of the Russian Academy of Medical Sciences, Head of the Combined Treatment Methods and Chemotherapy of Malignant Tumors Department, an associate member of the Russian Academy of Sciences, professor M.R. Lichinitser.
55 patients with different solid tumors (melanoma, pulmonary cancer, breast cancer, colon cancer, etc.) in the disseminated stage of the disease were enrolled. The specialists established that REFNOT has shown unique immunomodulating properties in cancer patients. What differentiates it from other known immunomodulators, is its positive effecton 2 cell populations simultaneously – T- and NK-cells, which are the leading populations of antitumor immunity. Besides, REFNOT increases the immune potential in cancer patients withinitially unaffected immune status.
Based on these results, it is recommended using REFNOT as an immunomodulator either solely or in combination with cytostatic drugs in patients with malignant tumors. The study will be continued in 2012. Based on the results of the aforementioned postmarketingstudy, in mid December 2011, documents were submitted to the Ministry of Healthcare and Social Development of the Russian Federation to introduce certain changes to the REFNOT label. The main change is the addition to the existing indications: as an immunomodulator for different malignant tumors.
Date: November 2011
The reason for conducting a research of REFNOT titled “The effect of REFNOT on the immunityin cancer patients” was the decision to extend the list of its proposed indications.
Research objectives: to study clinical immunological effects of REFNOT in monotherapy of solid tumors and in combination with chemotherapy; to characterize the immunity markers and the level of cytokines during application of REFNOT in monotherapy of solid tumors and in combination with chemotherapy.
The studywas conducted in the Nikolai Blokhin Russian Cancer Research Center of the Russian Academy of Medical Sciences, the principal investigator is the deputy research director of the Nikolai Blokhin Russian Cancer Research Center of the Russian Academy of Medical Sciences, Head of the Combined Treatment Methods and Chemotherapy of Malignant Tumors Department, an associate member of the Russian Academy of Sciences, professor M.R. Lichinitser.
55 patients with different solid tumors (melanoma, pulmonary cancer, breast cancer, colon cancer, etc.) in the disseminated stage of the disease were enrolled. The specialists established that REFNOT has shown unique immunomodulating properties in cancer patients. What differentiates it from other known immunomodulators, is its positive effecton 2 cell populations simultaneously – T- and NK-cells, which are the leading populations of antitumor immunity. Besides, REFNOT increases the immune potential in cancer patients withinitially unaffected immune status.
Based on these results, it is recommended using REFNOT as an immunomodulator either solely or in combination with cytostatic drugs in patients with malignant tumors. The study will be continued in 2012. Based on the results of the aforementioned postmarketingstudy, in mid December 2011, documents were submitted to the Ministry of Healthcare and Social Development of the Russian Federation to introduce certain changes to the REFNOT label. The main change is the addition to the existing indications: as an immunomodulator for different malignant tumors.
Date: November 2011