Monday, December 18, 2006

Institute seeks MS patients for drug trials

Bradenton Herald - Dec. 16, 2006

If you or someone you know has the relapsing/remitting form of multiple sclerosis, grab your scissors and clip this article or e-mail it to your friend or relative.

The Roskamp Institute in Sarasota is screening potential candidates for a research study on an experimental MS drug called fingolimod that has shown promise in earlier clinical trials. It was developed by Novartis.

What makes fingolimod so exciting is the fact that this is a once-a-day capsule, said Dr. Richard Mullan, Roskamp's director.

Currently the only treatment option available for this type of MS is a drug that must be given by injection, Mullan said.

The fingolimod study, which is part of the FDA approval process, is designed to determine the effectiveness and safety of the drug. fingolimod appears to help relapsing/remitting MS patients by causing white blood cells to move away from areas of inflammation and retreat to the lymph system, thereby lessening the symptoms.

The white cells known as T-cells are responsible for immune reactions that characterize MS, Mullan said.

And it's here - the trigger that causes the white cells to retreat - where one finds the connection that links one of the nation's leading research institutes in Alzheimer's disease with research on multiple sclerosis.

Roskamp scientists have found that patients with Alzheimer's disease and patients with MS have the same marker on their T-cells.

This marker appears to act as a switch, directing the T-cells' response, said Mullan.

In the case of Alzheimer's it triggers a decrease in T-cells. That leads to a build-up of a sticky substance, a protein called beta amyloid, in the brain. The build-up causes major damage to neurons, Mullan said.

In MS patients, the marker appears to cause the T-cells to aggressively attack the body.

It's this very research in how that marker works to influence the T-cell that has Roskamp scientists excited, said Dr. Andrew Keegan, an investigator in the clinical trials division participating in the fingolimod study.

Results so far in European clinical studies are promising.

Data recently presented at the 15th European Neurological Society in Vienna showed that fingolimod reduced the rate of clinical relapses by more than 50 percent and inflammatory disease activity as measured by magnetic resonance imaging by up to 80 percent over six months compared to a placebo, according to the Novartis' Web site.

Benefits were seen as soon as after two months of treatment and continued to increase over the six-month treatment period, Novartis said.

The drug appeared to be well-tolerated by trial participants, according to Novartis.

Roskamp's commitment to finding cures to neurodegenerative disorders has put the Sarasota institute in the forefront of the latest research.

The fingolimod study will have three groups of participants. One group will get a moderate dose of the experimental drug, the second group will get a lower dose and the third group will be given a placebo, Mullan said.

For more information, contact the Roskamp Institute at 256-8018 or visit the center's Web site at For more information on Novartis and fingolimod, check out

Donna Wright, health and social services reporter, can be reached at 745-7049 or at

Fingolimod clinical trials

The Roskamp Institute of Sarasota is recruiting participants for clinical trials of fingolimod, a new oral medication developed by Novartis that may offer a new treatment option in the future.

Eligibility requirements:

18-55 years of age

Diagnosed relapsing-remitting multiple sclerosis

Ambulatory (some assisted devices allowed)

Medically stable

Have had one relapse in past year or two relapse over last two years

Not currently on medication

Be able to participate in local medical exams

About multiple sclerosis

MS is a chronic, progressive, potentially disabling disorder of the central nervous system affecting young people in the prime of their lives.

MS is the leading cause of neurological disability in young adults and is twice as common in women as it is in men.

MS is usually diagnosed between the ages of 20 and 40.

The relapsing-remitting course is the most common form of the disease.

About 50 percent of patients advance to the secondary progressive (SPMS) form of the disease within 10 years.

Source: Roskamp Institute and Novartis