Results of a phase I study in patients suffering from secondary-progressive multiple sclerosis demonstrating the safety of the amino acid copolymer PI-2301 and a possible induction of an anti-inflammatory cytokine response

被引：9

作者：

Kovalchin, J. ^{[1
]}

Krieger, J. ^{[1
]}

Genova, M. ^{[1
]}

Collins, K. ^{[1
]}

Augustyniak, M. ^{[1
]}

Masci, A. ^{[1
]}

Hittinger, T. ^{[1
]}

Kuca, B. ^{[1
]}

Edan, G. ^{[2
]}

Braudeau, C. ^{[3
]}

Rimbert, M. ^{[3
]}

Patel, U. ^{[1
]}

Mascioli, E. ^{[1
]}

Zanelli, E. ^{[1
]}

机构：

[1] Peptimmune Inc, Cambridge, MA 02139 USA

[2] Ctr Hosp Univ, INSERM, Serv Neurol, CIC P 02 03, F-35033 Rennes, France

[3] Hop Hotel Dieu, CHU, CIMNA, F-44093 Nantes, France

来源：

JOURNAL OF NEUROIMMUNOLOGY | 2010年 / 225卷 / 1-2期

关键词：

Multiple sclerosis; Immunomodulatory therapy; Th2; immunity; Interleukin-13; Serum biomarkers; Pharmacokinetics; MYELIN BASIC-PROTEIN; EXPERIMENTAL AUTOIMMUNE ENCEPHALOMYELITIS; MONOCYTE CHEMOATTRACTANT PROTEIN-1; GLATIRAMER ACETATE; DENDRITIC CELLS; DOUBLE-BLIND; DISEASE; IL-13; POLARIZATION; INFLAMMATION;

D O I：

10.1016/j.jneuroim.2010.04.008

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

PI-2301 is an immunomodulator that could be an alternative therapy for MS. A placebo-controlled, multiple-ascending dose, double-blind study was performed in patients with secondary-progressive MS. Treatment was given subcutaneously once weekly for 8 weeks, followed by a 4-week open-label treatment period with active drug. The most common adverse event was transient injection site reactions. Non-significant trend for increases in serum levels of IL-3, IL-13, and CCL22 over time were suggestive of a beneficial T(H)2 immune response in subjects dosed with PI-2301 at 3 and 10 mg. MRI data indicated a non-significant trend for a reduction of lesion numbers in subjects treated with 1 and 3 mg PI-2301. (C) 2010 Elsevier B.V. All rights reserved.

引用

页码：153 / 163

页数：11

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