Tuesday, May 02, 2000
By Virginia Linn, Post-Gazette Staff Writer
A study is under way locally to test the safety and effectiveness of a pill that may reduce the severity or even halt the progression of the most common form of multiple sclerosis.
Eighty-five percent of the 350,000 people in the United States who have MS have the relapsing-remitting form, which is characterized by attacks followed by periods of remission. About 3,000 people in the Pittsburgh area have MS.
One of the approved treatments, glatiramer acetate or Copaxone, is available only in a daily injection, usually given by the patients themselves. Because many patients are uncomfortable giving themselves shots, many do not seek treatment.
"We are hoping [the drug] will work even better when taken orally," said Dr. Thomas F. Scott, a neurologist and director of the Allegheny Multiple Sclerosis Treatment Center at Allegheny General Hospital. Scott is directing the local portion of the global clinical trial, called the Coral Study -- the largest MS study of its kind.
Multiple sclerosis is an autoimmune disease in which the body mistakenly attacks the nerve fiber covering called myelin. The term multiple sclerosis comes from the multiple areas of scarring, or sclerosis, where myelin breaks down.
In the relapsing-remitting form, the person is free of symptoms during remission. During relapses, a person can develop substantial physical disability, including numbness, blurred vision, difficulty walking, pain and even paralysis.
The protein compound being studied is intended for people in the early stages of the disease --the first five to 10 years, said Scott, who was involved in the development of the injectable form of Copaxone and has other MS research under way.
Although it is too early to tell, Scott said Copaxone may actually halt the disease for some people. In data involving people who have taken the drug for five or six years, two-thirds of them have not experienced progression of the symptoms. That is twice as many people than would be expected if no medication was used, he said.
For more information
To sign up for the study, call (877) 31CORAL.
"We're hoping it ultimately will halt the progression of the disease," Scott said. "That has been our hope with all these medicines. It's only been in the last few years we've had medicines to slow the progression."
The Coral Study, involving 1,300 participants worldwide (600 to 700 in the United States), is a randomized, double-blind study. Participants will receive a daily dose of either 50 milligrams or 5 milligrams of oral glatiramer acetate or a placebo.
Early testing shows no side effects with the pill.
The study is being funded by Teva Marion Partners and Teva Pharmaceutical Industries Ltd., the marketer and manufacturer of Copaxone, respectively.
Scott said he has enrolled 10 patients and is seeking up to another 20 for the Pittsburgh site. Eligible participants, aged 18 to 50, must meet certain criteria.
If the drug is determined to be effective, he expects it to be on the
market in about two years.