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.
SOURCE Peptimmune, Inc.
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Related links:
http://www.peptimmune.com
CONTACT:
Thomas P. Mathers of Peptimmune, Inc.,
+1-617-715-8040
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