Sunday, September 03, 2000
University and VA hospitals taking part in new study
By Lois M. Collins
Deseret News staff writer
Studies have confirmed that injections of glatiramer acetate reduce the relapse rate and delay onset of disability in people who have multiple sclerosis. Now researchers want to know if an oral version of the same medication will have the same effect.
University Hospital and the VA Hospital are taking part in a study of the medication, marketed in injection form as Copaxone, to see whether it's effective in oral form and, if so, at what doses, according to Dr. John Rose.
Multiple sclerosis is a central nervous system disorder. Symptoms can range from mild numbness or tingling to paralysis or blindness. Muscles become weak and limbs lose their coordination. Fatigue is common.
Many people have a form of the illness called "relapsing/remitting" because their symptoms come and go, often changing. For some of them, the disease reaches a stage where the symptoms are permanent. Others see a steady progression of the disease.
The peak time for women to develop symptoms of MS is in their 20s to 30s, while men get it in their 30s to 50s. Women with the disease outnumber the men 2 to 1, but men are more apt to have the progressive form of the disease. Though no definitive cause has been found, researchers believe it has genetic roots and, most likely, some kind of environmental trigger to "turn it on." They've found a genetic marker for the gene, but not the gene itself.
Copaxone in injection form received FDA approval in 1996 after clinical trials showed dramatic reductions in relapses and delays in onset of disability. It was a major breakthrough in what is still an incurable disease, Rose said.
The medication was discovered by accident originally. A medical research team in Israel was trying to make a polymer of basic amino acids that would mimic MS in animals. What they found, instead, was that the compound inhibited the destruction of the protein myelin, which is believed to cause symptoms of MS. Myelin assures that nerve impulses are conducted properly and, without it, the nerves' "messages" don't get carried between the brain and the body.
In the six years of follow-up since the clinical trial, the average participant has maintained his disease without noticeable deterioration. Plans are to study those patients for a full 10 years, which will make it the longest organized study ever of an MS treatment.
The multi-center, international study of an oral form of the medication will include having frequent magnetic resonance imaging, which shows doctors visually the lesions that occur on the brain and spinal cord with multiple sclerosis. And like the earlier study, it will be double-blind, meaning neither patient nor doctor knows who got medication and who received a placebo.
A related study will look at the people with MS who have the progressive form, rather than remitting/relapsing MS. Copaxone has proven effective for many people in the latter category, but its efficacy in injectable form has not been proven for the former. It's an "outside chance, but there's nothing else, so it's well worth the try," Rose said.
More than 1,000 people will be enrolled in the oral Copaxone study and
the data will be collected for a year. Should the study show the substance
works, Rose said publication of the findings and an application to the
FDA for approval of oral glatiramer acetate could occur within two years.