November 12, 2002
Teva Pharmaceuticals Industries, Ltd. announced in a press release dated November 7, 2002, that it has prematurely terminated the “PROMiSe” trial – a controlled clinical trial testing the safety and effectiveness of Copaxone® (glatiramer acetate) for primary-progressive MS. An interim analysis of trial data by an independent monitoring committee indicated that, while there have been no safety concerns, the trial could not indicate the benefit of Copaxone over placebo, even if continued to its intended completion date.
Primary-progressive MS is characterized by gradual worsening or progression of disease from its onset, without more typical “relapses and remissions.” Primary-progressive MS affects about 10-15% of all individuals with MS. There are currently no therapies shown to be safe and effective for this form of multiple sclerosis.
Copaxone is an immunomodulatory agent that has been shown to be effective in reducing relapses and has been available by prescription for relapsing-remitting MS in the United States since late 1996. In March 1999, Teva began the PROMiSe trial to test the safety and efficacy of Copaxone versus inactive placebo in some 900 individuals with primary-progressive MS at some 54 MS centers in the U.S., Canada and Europe.
Two years into the three-year trial, the study’s independent data safety monitoring committee conducted a preplanned interim analysis to formally assess possible effectiveness. The analysis showed that after two years, the drug’s safety appeared acceptable, but the study as designed was very unlikely to show any statistical difference between treated and placebo subjects, suggesting no treatment benefit even if continued to its completion of three years of treatment. Although the data accumulated in the trial will provide new information on primary-progressive MS that will help design future trials, unfortunately, the PROMiSe study will not yield a treatment for people with this relatively rare form of the disease.
Individuals concerned about management strategies for primary-progressive MS should consult their personal physicians.
-- Research Programs Department
© 2002 The National Multiple Sclerosis Society