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

J. Kovalchin , J. Krieger , M. Genova , K. Collins , M. Augustyniak , A. Masci , T. Hittinger , B. Kuca , Gilles Edan (1, 2) , C. Braudeau (3) , M. Rimbert (3) , U. Patel , E. Mascioli , E. Zanelli

1 CHU Pontchaillou [Rennes]
2 CIC - Centre d'Investigation Clinique [Rennes]
3 CHU Nantes - Centre hospitalier universitaire de Nantes

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.

Keywords: Multiple sclerosis; Immunomodulatory therapy; Th2 immunity; Interleukin-13; Serum biomarkers; Pharmacokinetics

Domains: Life Sciences [q-bio]

J. Kovalchin, J. Krieger, M. Genova, K. Collins, M. Augustyniak, et al.. 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. Journal of Neuroimmunology, 2010, 225 (1-2), pp.153-163. ⟨10.1016/j.jneuroim.2010.04.008⟩. ⟨hal-01874527⟩