News Archive
Peptimmune Initiates Phase I Study with a Novel Peptide Copolymer for the Treatment of Multiple Sclerosis
Publication Date October 13, 2007
CAMBRIDGE, Mass. - October 3, 2007. 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, a novel peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.
Details
CAMBRIDGE, Mass. - October 3, 2007. 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, 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 will involve fifty-six healthy male volunteers who will receive the drug in eight escalating-dose cohorts. Following establishment of safety at potentially therapeutic doses, the Company will initiate its first repeat-dose study in multiple sclerosis patients in early 2008.
PI-2301 is a second-generation peptide copolymer from a similar compound class as Copaxone® (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 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 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.
"The commencement of this clinical trial is an important milestone for the development of PI-2301 and for the Company," stated Thomas Mathers, President and CEO of Peptimmune. "The goal for PI-2301 is to enhance the therapeutic benefit of a proven compound class in multiple sclerosis and give neurologists a new weapon as a primary treatment for patients with this debilitating disease."
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.
The Phase I single-ascending dose, double-blind, placebo-controlled randomized study will involve fifty-six healthy male volunteers who will receive the drug in eight escalating-dose cohorts. Following establishment of safety at potentially therapeutic doses, the Company will initiate its first repeat-dose study in multiple sclerosis patients in early 2008.
PI-2301 is a second-generation peptide copolymer from a similar compound class as Copaxone® (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 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 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.
"The commencement of this clinical trial is an important milestone for the development of PI-2301 and for the Company," stated Thomas Mathers, President and CEO of Peptimmune. "The goal for PI-2301 is to enhance the therapeutic benefit of a proven compound class in multiple sclerosis and give neurologists a new weapon as a primary treatment for patients with this debilitating disease."
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.
