Peptimmune Initiates Trial Of PI-2301 In Multiple Sclerosis Patients

Peptimmune, Inc a private biotechnology company, announced today that the doctors treated the first participant in a clinical trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of PI-2301 in patients with secondary progressive MS (SP-MS). PI-2301 is a new peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.
Phase Ib multiple ascending dose, double-blind, placebo-controlled, randomized study will include up to fifty-three subjects with SP-MS, who will receive the drug once a week for four doses escalating cohorts. After you create security for potentially therapeutic doses and proof of pharmacologic mechanism, the company plans to begin its Phase II study in patients with multiple sclerosis in early 2009.
PI-2301 is a second generation peptide copolymer from a similar class of compounds in the form of Copaxone (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response to the immune system and thereby control of pathogenic autoimmune response observed in some disease. In one step of increasing the dose, double-blind, placebo-controlled, randomized study, all doses of PI-2301 was safe and well tolerated and no serious side effects were observed. Pharmacodynamic assays demonstrated evidence of immune exposure in accordance with the pharmacologic mechanism of action for PI-2301, and a dose-dependent pharmacokinetics was observed.
PI-2301 has been optimized using the new platform Peptimmune peptide chemistry and in preclinical studies, showed a much more powerful and effective than Copaxone in treating disease models of multiple sclerosis. PI-2301 has also shown efficacy in preclinical models of autoimmune diseases in which immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis and autoimmune uveitis. Peptimmune has introduced a high-quality synthesis and analytical methods that provide the highest level from batch to batch reproducibility in the production of PI-2301.
More than 400,000 Americans with multiple sclerosis (MS), MS, and may affect more than 2.5 million people worldwide. MS an autoimmune disease in which the immune system reacts against individuals of several components of nerve-insulating myelin. The effects of these immune attack can range from relatively benign to somewhat disabling to devastating as communication between the brain and other parts of the body is disturbed.