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news.Peptimmune has completed first Phase I 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.
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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 second quarter of 2008.
Thomas Mathers, president and CEO of Peptimmune, said: “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.”