CAMBRIDGE, Mass., June 9 /PRNewswire/ -- Peptimmune, Inc., a privately held biotechnology company, presented early clinical results from its PI-2301 peptide copolymer program at both the 17th Annual ENS meeting in Nice, France and at FOCIS 2008 in Boston, MA. The Company presented data from its Phase Ia Single-Ascending-Dose, first-in-man study involving healthy, male adult volunteers following SC administration of the second-generation peptide copolymer PI-2301. This study demonstrated that all doses were safe and well tolerated, and demonstrated early immunological effects of PI-2301 consistent with its pharmacologic mechanism of action.
The Phase I single-ascending dose, double-blind placebo, controlled-randomized study involved fifty-six healthy volunteers who received the drug in eight escalating dose cohorts. All doses were safe and well tolerated (0.035 - 60mg), and there were no serious adverse events. Pharmacodynamic assays demonstrated evidence of immune exposure (tritium uptake, IL-13 in recall responses) consistent with the pharmacologic mechanism of action for PI-2301, and dose-related pharmacokinetics were observed (proprietary antibody-based assay). The Company plans to initiate its first repeat-dose study in multiple sclerosis patients in Q2/2008.
Peptimmune also presented data that details significant differences in the bioavailability, mechanism of action, and pharmacodynamic effects between PI-2301 and Copaxone(R) (Teva Pharmaceuticals). The Company demonstrated four-fold greater bioavailabilty of PI-2301 than Copaxone, and a significantly greater regulatory immune response than Copaxone. Both presentations are available on Peptimmune’s Web site at http://www.peptimmune.com/research_development/publications.
“We are pleased to see that PI-2301 was well tolerated and that this trial has provided evidence of PI-2301’s immunomodulatory effects. These data, along with the significant improvements on bioavailability and pharmacodynamic effects with PI-2301, provide further evidence that PI-2301 may replace Copaxone as first-line therapy in relapsing remitting multiple sclerosis,” 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. 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 MS may affect over 2.5 million individuals worldwide. 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.
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 BioVentures, Boston Medical Investors, and Silicon Valley Capital Partners. For additional information, access our Web site at http://www.peptimmune.com.
CONTACT: Thomas P. Mathers of Peptimmune, Inc., +1-617-715-8040
Web site: http://www.peptimmune.com/
