This Is MS Multiple Sclerosis Community: Knowledge & Support

Already on Dignan's list as a Phase I drug. Some more info. Strange that it's only being trialled (for safety) in men.

Peptimmune Initiates Phase I Study With a Novel Peptide Copolymer for the Treatment of Multiple Sclerosis 03 October 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 randomised study will involve 56 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 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 characterisation 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 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.

Source: Peptimmune, Inc.(03/10/07)

This is the first that I've heard of Peptimmune and PI2301 so the following could be entirely incorrect. However, from an experimental design perspective, choosing to study the drug in men only will minimize the variability of the sample population. As far as results analysis goes, it may help the study reach statistical significance by potentially maximizing the treatment effect. Of course, there could be other reasons as well. Perhaps this decision was based on the drug's tolerability in the preclinical animal tests though I'm just guessing here.

NHE