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Peptimmune Completes Phase Ib Study of PI-2301 in Multiple Sclerosis Patients
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The Phase Ib multiple-ascending dose, double-blind, placebo-controlled, randomized study enrolled 50 subjects with SP-MS. A total of 36 subjects received PI-2301 once weekly for 8 weeks followed by an open label extension of an additional 4 weeks. The doses ranged from 1 to 60 mg. Safety at all doses, including potentially therapeutic doses, was established. The most frequent adverse events (AEs) were dose-dependent site reactions which were mild to moderate, transient, and resolved without specific therapy. Dose-dependent increases in serum levels of anti-inflammatory markers were consistent with PI-2301 exposure as measured using the Company’s proprietary pharmacokinetic assay. The Company plans to continue developing this promising compound by initiating a Phase II study in relapsing remitting multiple sclerosis patients later this year.
"PI-2301 has now shown safety and pharmacologic activity in two clinical studies, the first in healthy volunteers, and this second in patients with multiple sclerosis. As we look forward to the Phase II, we are excited about the observed pharmacologic effects of PI-2301 in patients suffering from secondary progressive MS," stated Thomas P. Mathers, President and CEO of Peptimmune.
Data from this Phase Ib study will be presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Dr. Eric Zanelli will make a poster presentation titled "Clinical and biological results of a 12-week, double-blind, multiple ascending dose study evaluating the safety and tolerability of peptide copolymer PI-2301 in patients with the secondary progressive form of multiple sclerosis." The poster (P-422) will be presented within Topic 15 - Immunomodulation - 1 during the Poster Session I taking place on Thursday, September 10, 2009, between 2:30 and 5:00 p.m.
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About Peptimmune
Peptimmune, Inc. is a privately held clinical stage biotechnology company focused on the development of peptide therapies to improve the management of chronic autoimmune and inflammatory disorders. The Company is in clinical development with second-generation therapeutics that are expected to result in safer and more effective products for multiple sclerosis and pemphigus vulgaris. Current investors include New Enterprise Associates, MPM Capital, Hunt Ventures, Boston Medical Investors, Silicon Valley Bank Capital, and Genzyme Corporation. For additional information, please contact us.
