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The Phase I single ascending dose, double blind placebo controlledrandomized study involved 56 healthy volunteers who received the drug in eightescalating dose cohorts. All doses were safe and well tolerated, and therewere no serious adverse events. Pharmacodynamic assays demonstrated evidenceof immune exposure consistent with the pharmacologic mechanism of action forPI-2301, and dose related pharmacokinetics were observed. The Company plans toinitiate its first repeat dose study in multiple sclerosis patients in Q2/2008.
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"We are pleased to see that PI-2301 was well tolerated and that this trialhas provided evidence of single dose priming of healthy subjects. This effectis important as repeated doses in multiple sclerosis patients should lead totherapeutic immune modulation," stated Thomas P. Mathers, President and CEO ofPeptimmune. "We have designed PI-2301 to maximize the therapeutic benefit of aproven, safe compound class in multiple sclerosis as well as increasingpatients' convenience."
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 tocontrol the pathogenic autoimmune response in certain diseases. PI-2301 hasbeen optimized using Peptimmune's novel platform peptide chemistry and in pre-clinical studies, has shown to be more potent and effective than Copaxone intreating disease models for multiple sclerosis. PI-2301 has also shownefficacy in pre-clinical models of autoimmune diseases where immune modulationmay be effective, such as Crohn's disease, rheumatoid arthritis and autoimmuneuveitis. Peptimmune has also introduced highly reproducible manufacturingmethods that allow very strict control and characterization of PI-2301 andshould provide a superior level of batch to batch consistency.
Over 400,000 Americans have multiple sclerosis (MS), and worldwide MS mayaffect over 2.5 million individuals. MS is an autoimmune disease in which theindividuals' 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.
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 additional information, access our website athttp://www.peptimmune.com.
SOURCE Peptimmune, Inc.
