Wed, Apr. 23, 2003
By Sandy Kleffman
Contra Costa Times
Three times a week, 18-year-old Kristine Phillips has her father or best friend give her a painful shot to help cope with her multiple sclerosis.
But now a new drug about to undergo an international trial offers hope to MS patients that they may soon be able to avoid the inconvenience of regular injections.
The drug, Campath, helped slow the progression of the disease in small pilot studies in England.
"It would make life so much easier and less stressful," said Phillips, a Walnut Creek resident diagnosed with MS at 14. "I would be ecstatic. It would be the happiest news I've ever got."
Walnut Creek physician Michael Stein is one of only three doctors in California and 35 worldwide who will enroll about 150 people in the study, which will last three years.
Berkeley physician Joanna Cooper also will participate.
Campath, the brand name for the drug alemtuzumab, will be given intravenously for five consecutive days, but just once a year.
Other drugs now commonly used by MS patients often require shots several times a week or even daily.
"This is a fifth (drug) treatment option for patients," Stein said. "It is experimental. Patients taking this will be on the cutting edge of treatment."
Campath received accelerated approval from the Food and Drug Administration in 2001 for patients with chronic lymphocytic leukemia who have been unsuccessfully treated with chemotherapy.
Now ILEX Oncology, the maker of Campath, has embarked on a Phase II trial to determine how the drug works with MS patients.
Campath is not without side effects. About 25 percent to 30 percent of MS patients treated with the drug have developed Graves' disease, a serious but treatable thyroid condition.
More than 350,000 Americans have MS. It is twice as common among women as men. Most people are diagnosed between the ages of 20 and 50.
MS is believed to be an autoimmune disease in which the body's own defense system attacks myelin, the fatty substance that surrounds and protects the nerve fibers of the brain, optic nerves and spinal cord.
Those with MS often have near-normal life expectancies and learn to cope with the disease's symptoms, which range from mild to severe and can include numbness, paralysis, slurred speech, loss of vision and poor balance.
Campath targets rogue cells in a patient's immune system that attack nerves in the brain.
One big advantage is that unlike standard forms of chemotherapy, it doesn't involve as much of a shotgun approach by destroying both good and bad cells, Stein said.
"You may have heard in medicine there's the euphemism about looking for the magic bullet or the silver bullet," he said. "This is getting towards that, which is therapy that's very much specific to certain kinds of white blood cells."
ILEX officials contacted Stein last year and asked him to participate in the study. An ILEX spokesman said the firm selected physicians considered to be leaders in the field.
Stein also participated in a trial last year on the MS drug known as Rebif.
To be included in the Campath trial, people must have a relapsing-remitting form of MS, with symptoms that come and go.
People also must not have used any of the other drugs now taken for MS. This may make it difficult to find participants.
"It would not surprise me that I might have to screen 30 patients to get 10 who qualify," Stein said.
Participants will receive Campath free of charge and will be closely monitored for thyroid and other problems, Stein said. The drug would typically cost about $6,000 a year.
The study will compare Campath to Rebif, a drug now commonly taken by MS patients. One group of study participants will receive high doses of Campath, a second group will get low doses, and a third will receive Rebif, also at no charge.
Phillips can't participate in the study because she already uses Rebif three times a week. She receives the shots in her arm or leg.
She has just 8 percent vision in her right eye and has had problems with numbness on the left side of her body. Taking a drug for five days once a year would mean she wouldn't have to carry medicine with her every time she goes away for a few days.
"I could live a more normal teenage life," Phillips said.
TRIAL PATIENTS NEEDED
To participate in the study involving the drug Campath, people with multiple sclerosis must have a relapsing-remitting form of the disease and must not have used other MS medicines.
For more information, call Dr. Michael Stein's office in Walnut Creek
at 925-938-5252, or Dr. Joanna Cooper's office in Berkeley at 510-849-0499,
Copyright © 2003, Contra Costa Times