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.
About
PeptimmunePeptimmune, 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.
Peptimmune,
Inc.
http://www.peptimmune.com
