CAMBRIDGE, Mass., June 17 /PRNewswire/ -- Peptimmune, Inc. a privately
held biotechnology company, announced that physicians have treated the
first participant in a clinical trial to evaluate the safety, tolerability,
pharmacokinetics, and pharmacodynamics of PI-2301 in subjects with
Secondary Progressive Multiple Sclerosis (SP-MS). PI-2301 is a novel
peptide copolymer for the treatment of multiple sclerosis and other
autoimmune diseases.
The Phase Ib multiple-ascending dose, double-blind, placebo-controlled
randomized study will involve up to fifty-three subjects with SP-MS who
will receive the drug once weekly in four escalating-dose cohorts.
Following establishment of safety at potentially therapeutic doses and
proof of pharmacologic mechanism, the Company plans to initiate its Phase
II study in multiple sclerosis patients in early 2009.
"While the primary goal of this study is to demonstrate safety of
PI-2301 in multiple sclerosis patients, we believe that this clinical trial
is one of the most comprehensive looks at the pharmacologic effects of any
immunomodulator in patients suffering from autoimmune diseases," stated
Thomas P. Mathers, President and CEO of Peptimmune. Mr. Mathers will be
presenting an overview of the PI-2301 clinical program at the BIO 2008
Business Forum, Wednesday, June 18th, at 9:00 a.m. PDT at the San Diego
Convention Center, Room 2.
PI-2301 is a second-generation peptide copolymer from a similar
compound class as Copaxone(R) (Teva Pharmaceuticals). 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.
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.
SOURCE Peptimmune, Inc.
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Related links:
http://www.peptimmune.com
CONTACT:
Tom Mathers, Peptimmune, Inc.,
+1-617-715-8040
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