March 14, 2007 - Portland, Ore. - Artielle ImmunoTherapeutics, Inc. today announced that the Company has initiated a Phase I clinical trial to evaluate its novel drug candidate, RTL1000, for the treatment of multiple sclerosis (MS). RTL1000 is a novel protein drug with a highly-selective mechanism of action that targets pathogenic T-cells responsible for triggering and sustaining MS.
The trial is currently open for enrollment and is a multi-center, double-blind, placebo controlled, single dose Phase I study to be conducted with 30 MS patients in the United States. The clinical trial is designed to assess the safety and pharmacokinetic properties of RTL1000. The study will be conducted at research centers located in New Haven, Connecticut; Indianapolis, Indiana; Kansas City, Kansas; Baltimore, Maryland; Portland, Oregon and Seattle, Washington. Clinical trial information can be obtained at:
"The initiation of Phase I clinical trials is an important milestone for Artielle" said Al Ferro , Ph.D., President and CEO of Artielle. "In addition to demonstrating that RTL1000 is safe for human use, this initial trial is designed to provide pharmacokinetic and mechanistic data that will enable us to plan for later-stage clinical trials."
"RTL1000 has demonstrated impressive pre-clinical data in several different disease models and has the potential to add significantly to the clinical options for patients with this disease," said Dennis Bourdette, M.D., Chair & Swank Professor, Department of Neurology, Oregon Health & Science University (OHSU). "There remains a critical unmet need for new therapies for this disease and I am delighted to be involved with this program."
"The highly selective mechanism of action of this drug suggests it could have a very interesting profile as a new therapy. It targets only those cells involved in the disease process" said Arthur Vandenbark, Ph.D. Senior Research Career Scientist at the Portland Veteran Affairs Medical Center and Professor in the Department of Neurology and Department of Molecular Microbiology & Immunology at OHSU. "We look forward to seeing this therapy advance into human testing"
MS is a chronic autoimmune disease of the central nervous system. The damage to the central nervous system is caused by the destruction of the myelin sheath surrounding the nerve axons. The result is that the exposed axons are no longer able to send messages required to control movement, speech, and a wide variety of bodily functions. This debilitating disease affects about 400,000 Americans and about 2.5 million people worldwide.
MS is caused when T cells, part of the body's immune system, target nerves in the spinal cord and brain creating lesions in the myelin sheath. In MS, activation of these T cells triggers the release of inflammatory cytokines that lead to the destruction of the myelin. RTL1000 disrupts the activation of the T cells, preventing the release of the inflammatory cytokines and causing the release of anti-inflammatory cytokines. RTL1000 has been found to be both safe and efficacious in animal models of MS.
Artielle ImmunoTherapeutics is a privately held biotechnology company based in Tigard, Oregon. Artielle's research is focused on the development of therapeutics for the treatment of autoimmune diseases. In addition to its multiple sclerosis drug, the Company is developing drugs for the treatment of Rheumatoid Arthritis, Celiac Disease and Uveitis. Artielle has acquired the exclusive worldwide rights to these technologies from OHSU. For more information on the Company, visit www.artielle.com.