CAMBRIDGE, Mass., June 17 Peptimmune, Inc. a privatelyheld biotechnology company, announced that physicians have treated the firstparticipant in a clinical trial to evaluate the safety, tolerability,pharmacokinetics, and pharmacodynamics of PI-2301 in subjects with SecondaryProgressive Multiple Sclerosis (SP-MS). PI-2301 is a novel peptide copolymerfor the treatment of multiple sclerosis and other autoimmune diseases.
The Phase Ib multiple-ascending dose, double-blind, placebo-controlledrandomized study will involve up to fifty-three subjects with SP-MS who willreceive the drug once weekly in four escalating-dose cohorts. Followingestablishment of safety at potentially therapeutic doses and proof ofpharmacologic mechanism, the Company plans to initiate its Phase II study inmultiple sclerosis patients in early 2009.
"While the primary goal of this study is to demonstrate safety of PI-2301in multiple sclerosis patients, we believe that this clinical trial is one ofthe most comprehensive looks at the pharmacologic effects of anyimmunomodulator in patients suffering from autoimmune diseases," stated ThomasP. Mathers, President and CEO of Peptimmune. Mr. Mathers will be presenting anoverview of the PI-2301 clinical program at the BIO 2008 Business Forum,Wednesday, June 18th, at 9:00 a.m. PDT at the San Diego Convention Center,Room 2.
PI-2301 is a second-generation peptide copolymer from a similar compoundclass as Copaxone(R) (Teva Pharmaceuticals). 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 of batch-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 of nerve-insulating myelin. The effects of these immune-mediated attacks can range fromrelatively benign to somewhat disabling to devastating, as communicationbetween the brain and other parts of the body is disrupted.
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.
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SOURCE Peptimmune, Inc.