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.

Author(s): Kovalchin J, Krieger J, Genova M, Collins K, Augustyniak M, Masci A, Hittinger T, Kuca B, Edan G, Braudeau C, Rimbert M, Patel U, Mascioli E, Zanelli E

Affiliation(s): Peptimmune Inc., Cambridge, MA-02139, USA.

Publication date & source: 2010-08-25, J Neuroimmunol., 225(1-2):153-63. Epub 2010 May 13.

Publication type: Clinical Trial, Phase I; Randomized Controlled Trial

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. Copyright 2010 Elsevier B.V. All rights reserved.