October 13, 1994: Vol26n6: UB professor leads trial of new drug, first to slow MS progress

A clinical trial of a potential new drug for treating multiple
sclerosis, led by Lawrence Jacobs, UB professor of neurology, has
shown that the drug, a form of interferon, is the first to slow the
progression of the disease to disability. 
	Jacobs presented the results of the blinded clinical trial of
recombinant interferon beta on Oct. 10. at the annual meeting of the
American Neurological Association in San Francisco.
	Results of the four-year study showed that the drug lengthened
the time during which MS patients maintained their level of
functioning without becoming more disabled by 75 percent, compared to
patients receiving placebo. The drug also decreased the number of
exacerbations, or flare-ups of the disease, by one-third.
 	The trial was sponsored by the National Institutes of Health
and Biogen, a biotechnology company in Cambridge, Mass.
	Patients with active relapsing multiple sclerosis experience
an uneven pattern of disease progression, characterized by periods of
stability interrupted by flareups of the disease, after which the
patient returns to a new baseline of functioning. In the study,
recombinant interferon beta increased the time to progression of
disability - the length of the period during which active relapsing
patients sustain a particular baseline - by 75 percent.
	The trial also showed a 31 percent reduction in relapse rate
among patients experiencing the painful and debilitating exacerbations
that characterize the disease, and showed a significant reduction in
the number of active brain lesions measured by Magnetic Resonance
Imaging (MRI).
	Biogen's recombinant interferon beta is a genetically
engineered drug identical to the natural molecule that occurs in man
and acts both as an antiviral agent and as an immune-system booster.
It is administered intramuscularly once a week. The trial was the
first blinded trial to be done on a recombinant interferon identical
to natural beta interferon and the first to demonstrate a
statistically significant impact on the progression rate of the
disease.
	Only modest side effects were seen in the study. They included
occasional and transient flu-like symptoms (fever, fatigue and
achiness). Treated patients experienced flu-like symptoms an average
of eight days over two years, as compared to two days among the
placebo group. Injection-site reactions were minimal and not different
between groups treated with study drug and placebo. Nine percent of
recombinant interferon beta patients stopped treatment, half of which
were attributed to side effects.
	The study, which began in 1990, involved 301 men and women
with active relapsing multiple sclerosis who received either
recombinant interferon beta or placebo intramuscularly once a week for
periods up to two years. 
	The study was conducted at four clinical centers in the United
States: UB's Baird MS Center; Mellen MS Center, Cleveland Clinic;
University of Oregon, Portland; and Walter Reed Army Medical
Center/Georgetown University, Washington, DC. The MRI scores all were
analyzed at one laboratory at the University of Colorado in Denver.
	Multiple sclerosis is a progressive neurological disease in
which the body loses the ability to transmit messages among nerve
cells, leading to loss of muscle control, paralysis and, in some
cases, death. It affects between 250,000 to 350,000 Americans and is
believed to affect more than 1 million people worldwide. Although it
was first diagnosed more than 100 years ago, there is no prevention or
cure for the disease.
	More than 10,000 Americans are diagnosed with MS each year.
After epilepsy, it is the second most common chronic neurologic
disease of young adults. Onset is unusual before adolescence, then
rises in frequency from the teenage years to age 35, and declines
gradually thereafter. It is approximately twice as frequent in women
as in men. More than 100,000 patients in the U.S. suffer from the
relapsing form of the disease characterized by acute attacks, followed
by partial or complete remission.
	Recombinant interferon beta is still an investigational drug
and is not available on the market. Earlier this year, Biogen
announced plans to file for licensure in the United States and
regulatory approval in Europe in the first half of 1995.