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.
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.
Kovalchin
J
J
Peptimmune Inc., Cambridge, MA-02139, USA.
Krieger
J
J
Genova
M
M
Collins
K
K
Augustyniak
M
M
Masci
A
A
Hittinger
T
T
Kuca
B
B
Edan
G
G
Braudeau
C
C
Rimbert
M
M
Patel
U
U
Mascioli
E
E
Zanelli
E
E
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000097:blood / Q000627:therapeutic use; D000906:Antibodies / Q000097:blood; D016207:Cytokines / Q000378:metabolism*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D000068717:Glatiramer Acetate; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008875:Middle Aged; D020528:Multiple Sclerosis, Chronic Progressive / Q000188:drug therapy* / Q000276:immunology*; D010455:Peptides / Q000276:immunology / Q000627:therapeutic use*; D012720:Severity of Illness Index; D018418:Th2 Cells / Q000187:drug effects*; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000906:Antibodies; D016207:Cytokines; D010455:Peptides; D000068717:Glatiramer Acetate