Peptide Copolymer Study Completed For Multiple Sclerosis Treatment

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Peptimmune has completed its first clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PI-2301, a novel peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.

The Phase I single ascending dose, double blind placebo controlled randomized study involved 56 healthy volunteers who received the drug in eight escalating dose cohorts. All doses were safe and well tolerated, and there were no serious adverse events. Pharmacodynamic assays demonstrated evidence of immune exposure consistent with the pharmacologic mechanism of action for PI-2301, and dose related pharmacokinetics were observed. The Company plans to initiate 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 trial has provided evidence of single dose priming of healthy subjects. This effect is important as repeated doses in multiple sclerosis patients should lead to therapeutic immune modulation," stated Thomas P. Mathers, President and CEO of Peptimmune. "We have designed PI-2301 to maximize the therapeutic benefit of a proven, safe compound class in multiple sclerosis as well as increasing patients' convenience."

PI-2301 is a second generation peptide copolymer from a similar compound class as Copaxone (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response of the immune system to control the pathogenic autoimmune response in certain diseases. PI-2301 has been optimized using Peptimmune's novel platform peptide chemistry and in pre- clinical studies, has shown to be more potent and effective than Copaxone in treating disease models for multiple sclerosis. PI-2301 has also shown efficacy in pre-clinical models of autoimmune diseases where immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis and autoimmune uveitis. Peptimmune has also introduced highly reproducible manufacturing methods that allow very strict control and characterization of PI-2301 and should provide a superior level of batch to batch consistency.

Over 400,000 Americans have multiple sclerosis (MS), and worldwide MS may affect over 2.5 million individuals. MS is an autoimmune disease in which the individuals' immune system responds against multiple components of nerve- insulating myelin. The effects of these immune-mediated attacks can range from relatively benign to somewhat disabling to devastating, as communication between the brain and other parts of the body is disrupted.

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