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Artielle ImmunoTherapeutics Announces Positive Results of Phase 1 Multiple Sclerosis Trial
Date:9/14/2009

PORTLAND, Ore., Sept. 14 /PRNewswire/ -- Artielle ImmunoTherapeutics, a clinical stage biopharmaceutical company announced today the presentation of "Results of a Phase 1 safety study of RTL1000, a recombinant T-Cell receptor ligand specific for an immunodominant MOG peptide, in multiple sclerosis." The results were presented yesterday by one of Artielle's founding scientists, Arthur Vandenbark, Ph.D., at the Congress of the European Federation of Neurological Societies in Florence, Italy.

The presentation showed that this Phase 1 Study met its primary objective, which was to evaluate the safety profile and determine the maximum tolerated dose (MTD) of a single IV dose of RTL1000. Secondary objectives of the study were also met; these were to determine the pharmacokinetic profile of RTL1000 and assess immunologic parameters in a subset of Multiple Sclerosis (MS) patients. This was a first-in-human, double-blind, placebo controlled trial that enrolled 34 subjects with relapsing remitting and secondary progressive MS at six centers in the United States. All subjects were followed for clinical and MRI changes, pharmacokinetics and cytokine levels in plasma and blood mononuclear cells.

According to Dr. Arthur Vandenbark, "This trial demonstrated that RTL1000 was safe and did not exacerbate MS disease activity at any of the tested doses. Although this study was not designed to assess efficacy, immunological data in a subgroup of patients indicated RTL1000 was biologically active."

"The successful completion of this Phase 1 study represents a major milestone in the potential treatment of this devastating disease and in the development of our proprietary platform technology," said Dr. Al Ferro, President and CEO of Artielle ImmunoTherapeutics, Inc. "We plan to move aggressively to bring these novel, first-in-class products to the market place."

Worldwide, multiple sclerosis (MS) is thought to affect more than 2.5 million people. MS is a chronic autoimmune disease caused when T cells, part of the body's immune system, attack the central nervous system (CNS), which is made up of the brain, spinal cord and optic nerves. Symptoms may be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision. In MS, activation of these T cells triggers the release of inflammatory cytokines that lead to the destruction of the myelin, the fatty substance that surrounds and protects the nerve fibers in the central nervous system. When any part of the myelin sheath or nerve fiber is damaged or destroyed, nerve impulses traveling to and from the brain and spinal cord are distorted or interrupted, producing the variety of symptoms that can occur. As demonstrated in animal studies, RTL1000 inhibits the activation of myelin-reactive T cells, preventing the release of inflammatory cytokines and causing the release of anti-inflammatory cytokines. Artielle has also shown in models of MS that animals treated with RTL1000 demonstrate repair of the myelin sheath.

About Artielle ImmunoTherapeutics, Inc.

Artielle ImmunoTherapeutics, Inc., headquartered in Portland, Oregon, is a clinical stage biopharmaceutical company with a platform technology for inflammatory diseases. Artielle's core technology has generated a new proprietary class of molecules known as Recombinant T cell receptor Ligands (RTLs) that can be tailored to treat a wide range of autoimmune diseases. The company has recently completed Phase 1 clinical safety trial for lead drug candidate, RTL1000, for multiple sclerosis. In addition to multiple sclerosis, Artielle is also conducting research in various pre-clinical phases on other autoimmune disease to which its platform technology is applicable such as celiac disease, uveitis, rheumatoid arthritis, type 1 diabetes and other diseases. The company's technology platform is the subject of an exclusive worldwide license from Oregon Health & Science University and is protected by multiple issued US and foreign patents and patent applications. For more information please visit www.artielle.com


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SOURCE Artielle ImmunoTherapeutics
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