OHSU tests MS drug in clinical trial

Portland Business Journal - 10:35 AM PDT Monday, May 21, 2007

A 55-year-old Montesano, Wash., woman will be the first person in the Northwest to be treated with a promising developed entirely at Oregon Health & Science University and the Portland Veterans Affairs Medical Center.

Anne Foster, who has secondary-progressive MS, will be the third person in the country to receive an infusion of the OHSU/VAMC-invented drug, RTL1000, as part of a Phase I trial when she arrives Monday for treatment at OHSU's Center for Health & Healing. She will be awake as the drug is administered intravenously and will stay in the hospital for 24 hours for evaluation.
During the Phase I trial on RTL1000, initiated by Tigard-based Artielle ImmunoTherapeutics Inc., researchers will test the drug in a total of 30 participants at six study sites, including OHSU, Yale University, Indiana University, University of Kansas Medical Center, University of Maryland, and the MS Center at Evergreen, in Kirkland, Wash. They will evaluate its safety, determine a safe dosage range and identify side effects.

OHSU and VAMC researchers who developed RTL1000 are enthusiastic about the drug's potential. Named for the "recombinant T-cell receptor ligand" that is the center of its activity, RTL1000 is a highly selective protein that binds to disease-causing white blood cells, or T-cells, and inactivates them.

MS is caused by a subgroup of pathogenic T-cells that attack myelin, the fatty sheath insulating nerve fibers in the brain and spinal cord, and cause the fibers to lose their ability to conduct impulses. RTL1000 was bioengineered to bind specifically to the T-cells believed to cause MS, and then inactivate or "stun" these cells.

Arthur Vandenbark, a professor of neurology and molecular microbiology and immunology at the OHSU School of Medicine, and senior research career scientist at the VAMC, led the RTL1000 research team that included Halina Offner, a professor of neurology and anesthesiology and peri-operative medicine at OHSU and the VAMC, and Gregory Burrows, OHSU research associate professor of neurology.

Vandenbark called the clinical trial with RTL1000 "the holy grail" of his research.

In early studies that Vandenbark, Offner and Burrows conducted on mouse models for MS, RTL1000 appeared to reverse demyelination and nerve fiber damage. That meant the drug was both neuroregenerative and neuroprotective.

RTL1000's appearance in a clinical trial is the culmination of more than 20 years of work by MS scientists and clinicians at OHSU and the VAMC to develop a treatment that enhances the body's natural ability to control disease-causing T-cells. They recently helped launched an international trial for another MS drug invented by Vandenbark and Offner, called NeuroVax, that boosts the activity of protective T-cells that regulate MS. This treatment approach, referred to as T-cell receptor peptide vaccination, may also prove useful for treating a variety of autoimmune diseases, such as diabetes mellitus and rheumatoid arthritis.

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