July 30, 2008
Peptimmune Announces Grant of United States Patent for PI-2301 Peptide Copolymer for Multiple Sclerosis
CAMBRIDGE, Mass., July 30 /PRNewswire/ -- Peptimmune, Inc. a privately held biotechnology company, announced today the grant of US Patent Number 7,381,790 (the '790 patent) which protects the composition of matter for its PI-2301 peptide copolymer for the treatment of autoimmune diseases.
PI-2301 is currently in a Phase Ib multiple-ascending dose, double-blind, placebo-controlled randomized study in subjects with multiple sclerosis. Following establishment of safety at potentially therapeutic doses and proof of pharmacologic mechanism, the Company plans to initiate its Phase II study in relapsing remitting multiple sclerosis patients in early 2009.
"This patent represents an important component in the development of our intellectual property in peptide copolymers, including PI-2301," stated Thomas P. Mathers, President and CEO of Peptimmune. "The '790 patent protects what we believe may become a very important therapy for the treatment of multiple sclerosis and other autoimmune diseases."
PI-2301 is a second-generation peptide copolymer from a similar compound class as Copaxone(R) (Teva Pharmaceuticals). PI-2301 has been designed to be more efficacious and more convenient (weekly versus daily dosing) than Copaxone for the treatment of multiple sclerosis. PI-2301 works through immune modulation by enhancing the regulatory response of the immune system and thereby controlling the pathogenic autoimmune response observed in some diseases. In a Phase I single ascending dose, double blind placebo controlled randomized study, all doses of PI-2301 were safe and well tolerated, and no serious adverse events were observed. Pharmacodynamic assays demonstrated evidence of immune exposure consistent with the pharmacologic mechanism of action for PI-2301, and dose-dependent pharmacokinetics was observed.
PI-2301 has been optimized using Peptimmune's novel platform peptide chemistry and, in preclinical 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 preclinical models of autoimmune diseases where immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis, and autoimmune uveitis. Peptimmune has put in place high-quality synthesis and analytical methods that provide a superior level of batch-to-batch reproducibility in the manufacturing of PI-2301.
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.
The '790 patent claims "A linear random copolymer YFAK comprising amino acids tyrosine (Y), phenylalanine (F), alanine (A), and lysine (K)," )." which was licensed from Harvard University. The copolymer technology was developed in conjunction with Professor Jack L. Strominger M.D., Higgins Professor of Biochemistry, Department of Molecular and Cellular Biology, at Harvard University. Peptimmune is the exclusive worldwide licensee of the '790 patent.
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.
For information please contact Tom Mathers at (617) 715-8000 or [email protected]
CONTACT: Tom Mathers of Peptimmune, Inc., +1-617-715-8000,[email protected]
Web site: http://www.peptimmune.com/