Some exciting news about new drug options for MS. I can’t wait to pop a pill!
2007 Marks Great Progress in Drug Development for MS
By Sara Bernstein from the site: http://www.nationalmssociety.org/site/PageServer?pagename=HOM_RES_highlights_drugdevelopment
There are now 132 ongoing, planned, or recently completed clinical trials in multiple sclerosis, according to “Clinical Trials in Multiple Sclerosis 2007” a list compiled by the National MS Society.* This vibrant scene is bringing new hope for oral drugs, for better options for progressive disease, and for novel approaches to alleviating symptoms.
More than 30,000 people with virtually all types of MS have participated in these studies; without their help and that of thousands in the future, developing better treatments for this disease would be impossible.
Oral therapies are a hot topic in MS drug development. Currently approved MS treatments require ongoing injections or infusions that can cause significant reactions and discomfort.
“Developing oral therapies that are safe and effective is crucial,” says John Richert, MD, Executive Vice President for Research & Clinical Programs for the Society. “More and more studies are showing how important early treatment is for improving the course of MS down the road, and having approved oral therapies would greatly increase the proportion of people who are willing to get on therapy early and to remain on therapy.”
Oral laquinimod (Teva Pharmaceuticals), an immune-modulating drug, is under study in 1,000 people with relapsing-remitting MS (RR MS, a course of MS characterized by clearly defined flare-ups followed by complete or partial remissions). Results of an earlier study in 306 people showed that 0.6 mg of laquinimod reduced the number of active lesions by 38% when compared with placebo, but not 0.3 mg. The new study is comparing the higher dose against placebo.
Oral cladribine (EMD Serono) is being tested in 1,290 people with RR MS worldwide. Cladribine is a medication that has been used to treat hairy cell leukemia. Pilot studies have suggested a benefit in both RR and progressive MS, and while a trial in progressive forms of MS showed no clinicabenefit, it did show a significant reduction in MRI-detected disease activity. The drug already has been designated by the FDA as a “fast-track product,” which should expedite its review when the trial is completed.
Fingolimod (FTY720, Novartis Pharmaceuticals) an oral drug that binds to a docking site on immune cells, preventing them from attacking the brain and spinal cord is under study in 2,000 people with RR MS in Europe and North America. This study is based on results of a smaller earlier study reported in 2006, which showed that up to 77% of people taking fingolimod in a cohort of 255 people with active, relapsing MS remained relapse-free over two years.
Teriflunomide (Sanofi-Aventis), an oral agent that may modulate T cells, is being tested in 1,050 people with RR MS in Europe and North America. Earlier results showed that teriflunomide significantly reduced MRI-detected disease activity in 179 people with relapsing MS.
A controlled clinical trial of oral estriol, a sex hormone, added to Copaxone® (glatiramer acetate, Teva Pharmaceutical Industries Ltd.) is starting in 130 women with RR MS. This study is being funded by the National MS Society in partnership with the Society’s Southern California chapter and the National Institute of Neurological Disorders and Stroke. Rhonda Voskuhl, MD lead investigator of this trial had conducted an early-phase trial of estriol in 12 women with MS, and found decreases in disease activity during estriol treatment in women with RR MS.
Oral fumarate (BG00012, Biogen Idec) is being tested in 1,011 people with RR MS. This drug inhibits immune cells and molecules, shifting the immune response from inflammatory to anti-inflammatory. In an earlier study in 257 people with RR MS, treatment with high dose BG00012 led to a 69% reduction in active inflammation on MRI scans.
*Clinical Trials in MS 2007 is available online at www.nationalmssociety.org/ClinicalTrials