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PI-2301 is currently in a Phase Ib multiple-ascending dose, double-blind,placebo-controlled randomized study in subjects with multiple sclerosis.Following establishment of safety at potentially therapeutic doses and proofof pharmacologic mechanism, the Company plans to initiate its Phase II studyin relapsing remitting multiple sclerosis patients in early 2009.
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PI-2301 is a second-generation peptide copolymer from a similar compoundclass as Copaxone(R) (Teva Pharmaceuticals). PI-2301 has been designed to bemore efficacious and more convenient (weekly versus daily dosing) thanCopaxone for the treatment of multiple sclerosis. PI-2301 works through immunemodulation by enhancing the regulatory response of the immune system andthereby controlling the pathogenic autoimmune response observed in somediseases. In a Phase I single ascending dose, double blind placebo controlledrandomized study, all doses of PI-2301 were safe and well tolerated, and noserious adverse events were observed. Pharmacodynamic assays demonstratedevidence of immune exposure consistent with the pharmacologic mechanism ofaction for PI-2301, and dose-dependent pharmacokinetics was observed.
PI-2301 has been optimized using Peptimmune's novel platform peptidechemistry and, in preclinical studies, has shown to be more potent andeffective than Copaxone in treating disease models for multiple sclerosis.PI-2301 has also shown efficacy in preclinical models of autoimmune diseaseswhere immune modulation may be effective, such as Crohn's disease, rheumatoidarthritis, and autoimmune uveitis. Peptimmune has put in place high-qualitysynthesis and analytical methods that provide a superior level ofbatch-to-batch reproducibility in the manufacturing of PI-2301.
Over 400,000 Americans have multiple sclerosis (MS), and MS may affectover 2.5 million individuals worldwide. MS is an autoimmune disease in whichthe individuals' immune system responds against multiple components ofnerve-insulating myelin. The effects of these immune-mediated attacks canrange from relatively benign to somewhat disabling to devastating, ascommunication between the brain and other parts of the body is disrupted.
About Peptimmune
Peptimmune, Inc. is a privately held clinical stage biotechnology companyfocused on the development of peptide therapies to improve the management ofchronic autoimmune and inflammatory disorders. The Company is in clinicaldevelopment with second-generation therapeutics that are expected to result insafer and more effective products for multiple sclerosis and pemphigusvulgaris. Current investors include New Enterprise Associates, MPM Capital,Hunt Ventures, Boston Medical Investors, Silicon Valley Bank Capital, andGenzyme Corporation.
For information please contact Tom Mathers at (617) 715-8000 [email protected].
SOURCE Peptimmune, Inc.
