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"We are pleased with the level of continuing support from our existinginvestors and the opportunity to expand our syndicate," stated Thomas P.Mathers, President and CEO. "The Series D investment will provide thenecessary capital to complete two clinical trials by the end of 2008: thecurrent single ascending dose in healthy volunteers and a multiple ascendingdose in multiple sclerosis patients, expected to start in Q2/08. Thecompletion of these two studies will offer proof of principal for PI-2301,which is a second generation copolymer targeted at treating patients withrelapsing and remitting multiple sclerosis."
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Financing Two Clinical Trials in Multiple Sclerosis
Peptimmune is currently completing its Phase I single ascending dose studyfor PI-2301, a double blind placebo controlled randomized study that involves56 healthy male volunteers who will receive the drug in eight escalating dosecohorts. Following establishment of safety at potentially therapeutic doses,the Company will initiate its first repeat dose study in multiple sclerosispatients in Q2/2008, where it will explore safety, pharmacokinetics andpharmacodynamics over eight to twelve weeks of dosing.
About PI-2301
PI-2301 is a second generation peptide copolymer from a similar compoundclass as Copaxone(R) (Teva Pharmaceuticals). PI-2301 works through immunemodulation by enhancing the regulatory response of the immune system tocontrol the pathogenic autoimmune response in certain diseases. PI-2301 hasbeen optimized using Peptimmune's novel platform peptide chemistry and inpre-clinical studies, has shown to be more potent and effective than Copaxonein treating disease models for multiple sclerosis. It is expected that weeklydosing administration with PI-2301 will provide greater patient convenienceand tolerability over Copaxone's daily dosing administration. PI-2301 hasalso shown efficacy in pre-clinical models of autoimmune diseases where immunemodulation may be effective, such as Crohn's disease, rheumatoid arthritis andautoimmune uveitis. Peptimmune has also introduced highly reproduciblemanufacturing methods that allow very strict control and characterization ofPI-2301 and should provide a superior level of batch to batch consistency.
Information on Multiple Sclerosis
Over 400,000 Americans have multiple sclerosis (MS), and worldwide MS mayaffect over 2.5 million individuals. MS is an autoimmune disease in which theindividual's immune system responds against multiple components ofnerve-insulating myelin. The effects of these immune-mediated attacks canrange from relatively benign to somewhat disabling to devastating, ascommunication between the brain and other parts of the body is disrupted.
About Peptimmune
Peptimmune, Inc. is a privately held clinical stage biotechnology companyfocused on the development of peptide therapies to improve the management ofchronic autoimmune and inflammatory disorders. The Company is in clinicaldevelopment with second-generation therapeutics that are expected to result insafer and more effective products for multiple sclerosis and pemphigusvulgaris. Current investors include New Enterprise Associates, MPM Capital,Hunt Ventures, Boston Medical Investor
