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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."

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SOURCE Artielle ImmunoTherapeutics
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