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Clinical Trial
. 2016:2016:2847232.
doi: 10.1155/2016/2847232. Epub 2016 Apr 28.

Administration of Myelin Basic Protein Peptides Encapsulated in Mannosylated Liposomes Normalizes Level of Serum TNF-α and IL-2 and Chemoattractants CCL2 and CCL4 in Multiple Sclerosis Patients

Yakov Lomakin  1 , Alexey Belogurov Jr  2 , Irina Glagoleva  3 , Alexey Stepanov  1 , Konstantin Zakharov  4 , John Okunola  3 , Ivan Smirnov  1 , Dmitry Genkin  4 , Alexander Gabibov  5
Affiliations
Clinical Trial

Administration of Myelin Basic Protein Peptides Encapsulated in Mannosylated Liposomes Normalizes Level of Serum TNF-α and IL-2 and Chemoattractants CCL2 and CCL4 in Multiple Sclerosis Patients

Yakov Lomakin et al. Mediators Inflamm. 2016.

Abstract

We have previously shown that immunodominant MBP peptides encapsulated in mannosylated liposomes (Xemys) effectively suppressed experimental allergic encephalomyelitis (EAE). Within the frames of the successfully completed phase I clinical trial, we investigated changes in the serum cytokine profile after Xemys administration in MS patients. We observed a statistically significant decrease of MCP-1/CCL2, MIP-1β/CCL4, IL-7, and IL-2 at the time of study completion. In contrast, the serum levels of TNF-α were remarkably elevated. Our data suggest that the administration of Xemys leads to a normalization of cytokine status in MS patients to values commonly reported for healthy subjects. These data are an important contribution for the upcoming Xemys clinical trials.

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Figures

Figure 1
Figure 1
Serum levels of cytokines (pg/mL) in the treatment group at the time of the screening (−2 weeks), 7, 10, and 18 weeks. The interquartile range is shown by boxes. The median in each group is shown by the bold line. Bars represent 95% confidence interval. Statistically significant differences with their respective p values are indicated. The green line represents cytokine levels in healthy individuals. The green-colored zone corresponds to the interquartile range in healthy individuals according to the previously reported data (see Section 2 for details). In the upper line, cytokines that had a statistically significant improvement are depicted.
Figure 2
Figure 2
The Th1/Th2 serum ratio in the treatment group at the time of the screening (−2 weeks), 7, 10, and 18 weeks. The interquartile range is shown by boxes. The median in each group is shown by the bold line. Bars represent 95% confidence interval. Statistically significant differences with their respective p values are indicated.
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