Peptimmune Completes Phase I Study With A Novel Peptide Copolymer For The Treatment Of Multiple Sclerosis

Peptimmune, Inc. a privately
held biotechnology company, announced that it has completed its first
clinical trial to evaluate the safety, tolerability, pharmacokinetics and
pharmacodynamics of PI-2301, a novel peptide copolymer for the treatment of
multiple sclerosis and other autoimmune diseases.


The Phase I single ascending dose, double blind placebo controlled
randomized study involved 56 healthy volunteers who received the drug in
eight escalating dose cohorts. All doses were safe and well tolerated, and
there were no serious adverse events. Pharmacodynamic assays demonstrated
evidence of immune exposure consistent with the pharmacologic mechanism of
action for PI-2301, and dose related pharmacokinetics were observed. The
Company plans to initiate its first repeat dose study in multiple sclerosis
patients in Q2/2008.



"We are pleased to see that PI-2301 was well tolerated and that this
trial has provided evidence of single dose priming of healthy subjects.
This effect is important as repeated doses in multiple sclerosis patients
should lead to therapeutic immune modulation," 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(R) (Teva Pharmaceuticals). 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 worldwide MS
may affect over 2.5 million individuals. 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,
access our website at peptimmune.


Peptimmune, Inc.

peptimmune



View drug information on Copaxone.

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