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 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, access our website at
http://www.peptimmune.com.
Peptimmune,
Inc.
http://www.peptimmune.com