News-Record.com

Like many people with relapsing-remitting multiple sclerosis, Lisa Allen of High Point injects herself every other day with drugs to treat the incurable disease.

But a new drug now entering a trial with 2,200 patients could let patients such as Allen with the most common type of MS take their treatment as a daily pill. A Wake Forest University Health Sciences neurologist, Dr. Douglas Jeffery, is part of the team leading the study.

"It's a very, very promising drug which has tremendous potential to be of use in MS and (provide) improved quality of life" for patients, Jeffery says.

A pill like that has been on MS patients' wish lists for a long time, Allen says.

"Everybody who's been in this has been praying for an oral thing," says Allen, who is 47 and learned in 1991 that she had the disease. "After all these years of doing (injections), for the most part I'm pretty well used to it ... but in certain places and at certain times, it still hurts, and I'd rather not have to do it that way."

Multiple sclerosis is a disease in which lesions grow in the brain and nervous system. Depending on location, they can harm vision, muscle control, coordination and balance, and thinking and memory. Allen has experienced fatigue, muscle spasticity in her lower body and numbness in her feet.

"I can walk still, thank God, but I do have to be careful of gravity sometimes," Allen says.

About 400,000 Americans and 2.5 million people worldwide have the disease. What causes it is poorly understood. Researchers believe it may be an autoimmune disorder, in which the body attacks itself, combined with genetics and perhaps an environmental factor such as a virus.

In relapsing-remitting MS, patients experience attacks or worsened neurologic function, followed by periods in which the patient recovers partly or completely. Attacks are not predictable, but certain triggers can make attacks more likely for some people. For Allen, one such trigger is hot weather.

Symptoms can be controlled with medication that can help prevent new lesions from forming. Allen injects a drug called interferon beta 1b.

The medicine under study, called laquinimod, is being given only to trial participants with the relapsing-remitting form of the disease.

In a study of laquinimod in 306 patients, reported June 19 in the British medical journal The Lancet, a dose of six-tenths of a milligram daily of laquinimod was found to reduce the number of new nervous-system lesions over nine months by more than 40 percent, compared with a placebo.

A smaller dose, three-tenths of a milligram, made no significant difference.

The study found that only two patients had serious side effects, which were treatable in both cases.

"It's very comparable to (primary drugs) on the market today," Jeffery said. "It's an oral medication with a very promising side-effect and safety profile."

That study was sponsored by Teva Pharmaceutical Industries, which makes the drug. Teva also is sponsoring the new trial.

That trial, involving 23 U.S. sites and 120 sites worldwide, will have two parts. One, involving about 1,000 people, will compare the effects of laquinimod with a placebo. The other, involving about 1,200 patients, will compare laquinimod with both a placebo and another drug currently used by MS patients.

The goal of the trial is to test the safety, effectiveness and tolerability of the drug. Test sites, including Wake Forest, are recruiting participants for the study.

Allen says she'll probably try to take part."I know there are risks, but I feel like I'm game for it," she says. "I'm in pretty good health. I'd be willing to take a chance if it helps other people, too."

Contact Lex Alexander at 373-7088 or lex.alexander@news-record.com