Thursday, November 2, 2000
By LYNNE LANGLEY
Of The Post and Courier staff
A drug commonly prescribed to lower cholesterol may help relieve symptoms and slow progression of multiple sclerosis, Charleston doctors announced Wednesday.
Medical University of South Carolina doctors will direct a national trial, beginning next month, in which MS patients take simvastatin (brand name Zocor) for six months to determine whether the drug is safe and effective.
If it is, the drug that more than 20 million people have taken worldwide may leap onto the federal Food and Drug Administration's fast track for approval to treat MS.
The medicine worked dramatically on rats in the MUSC laboratory of Dr. Inderjit Singh.
Rats with MS had increasing difficulty moving and became partially paralyzed. Rats given the drug, however, didn't just get up and walk. They romped around and ran in their exercise wheels.
All the treated rats completely recovered while those with MS that did not get the drug died, said Dr. Lyndon Key, the MUSC pediatrics professor who is principal investigator for the national trial.
"With lovastatin (a related drug) and simvastatin, this disease can be reversed," said Key. The drugs delayed symptoms, reduced their severity and led to complete recovery of the animals, he said.
"This is a very important new study," said MUSC President Dr. Ray Greenberg. "It's a wonderful example of taking basic research from the lab and applying it ... to benefit patients."
The medicine works by fighting inflammation, which causes damage in the brains of MS patients, Key said. And, it has implications for treating other illnesses caused by inflammation, such as stroke, Alzheimer's and spinal chord injury, Key said.
In the MS trial that starts next month, patients will have a series of MRIs to show how lesions in their brains - and thus their MS - respond to the medicine, Key said.
"Dr. Singh's research implies significant effect," said Dr. Timothy Vollmer, who will lead a branch of the drug trial at Yale University.
MS affects 350,000 people in the U.S. and 2.5 million worldwide, he said, adding that it costs the U.S. economy $10 billion a year.
MS patients may have difficulty walking, moving or thinking and may suffer vision problems or incontinence. The symptoms eventually progress to blindness, paralysis and death.
The four drugs approved for use thus far, all injections that cause side effects, only affect the course of MS moderately, Vollmer said. Patients report few side effects from the cholesterol-lowering drug.
"We are not sure that a patient severely crippled will be able to get up and walk, but young, newly diagnosed patients will have a better future," said Dr. Charles Darby, chairman of the MUSC pediatrics department.
Singh, a professor of pediatrics and cell biology, began what colleagues describe as ground-breaking research on the uncommon pediatric illness, Lorenzo's disease.
Singh's work on Lorenzo's disease, which causes the brain to degenerate, led to research on MS, which also results in destruction of nervous system tissue.
Patients will begin enrolling in the study next month at MUSC, Yale and the University of Colorado, 10 patients at each health center.
The trial might take a year, Key said.
Results, collected and analyzed at MUSC, could then go to the FDA, which
will weigh whether the drug is safe and works on MS. MUSC might immediately
petition FDA to approve the drug for MS, Key said.