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MS Trial Alert - Participants Sought for Two New Clinical Trials of Oral Drug BG00012 for Relapsing-Remitting MS - UPDATED

May 21, 2008

MS Trial Alert - Participants Sought for Two New Clinical Trials of Oral Drug BG00012 for Relapsing-Remitting MS - UPDATED

Summary:

Enrollment has begun for two large-scale clinical trials testing the safety and effectiveness of the experimental oral drug BG00012 (dimethyl fumarate, Biogen Idec, Inc) in people with relapsing-remitting multiple sclerosis. These phase III studies are known as the DEFINE study and the CONFIRM study. The DEFINE study compares two different doses of BG00012 against inactive placebo, and is enrolling 1011 patients at 160 sites in North America, Europe and other parts of the world. The CONFIRM study compares two different doses of BG00012, or injections of glatiramer acetate (Copaxone®, Teva Pharmaceutical Industries), against inactive placebo. That study is enrolling 1232 patients at 175 sites in North America, Europe and other parts of the world.  Both studies are being sponsored by Biogen Idec, Inc.

People with relapsing-remitting MS experience clearly defined flare-ups (also called relapses, attacks, or exacerbations) of acute worsening of neurologic function, followed by partial or complete recovery periods (remissions) free of disease progression.

Rationale:

Multiple sclerosis occurs when the immune system mistakenly attacks nerve fiber-insulating myelin and other brain and spinal cord tissues. Although its exact mechanism of action is not known, BG00012, an oral fumarate, is thought to inhibit immune cells and molecules and may be protective against damage to the central nervous system. Preliminary results of an earlier multicenter, controlled clinical trial of oral BG00012 involving 257 people with relapsing-remitting MS were reported at a major medical meeting in 2006. For 24 weeks, patients received either low, medium or high doses of BG00012 capsules or inactive placebo. Compared with placebo, treatment with high dose BG00012 led to a 69% reduction in active inflammation on MRI scans acquired at weeks 12 to 24.

Eligibility:

To enroll in either of these phase III studies, people must be 18-55 years of age, and must have a confirmed diagnosis of relapsing-remitting MS. Other entrance and exclusion criteria apply. For details on these studies, please see below, or visit:www.MSClinicalStudies.com.

Details of DEFINE:

The primary goal of the DEFINE study is to determine whether BG00012 can decrease the proportion of participants experiencing relapses and whether the agent is safe and well tolerated. Secondary objectives include assessing the drug’s effects on the frequency of relapses, disability progression, disease activity detected by MRI and other measures.

For the two-year DEFINE study, participants will be randomly assigned to one of 3 groups:

Group 1 will take 2 capsules orally, 3 times a day, of low dose BG00012 plus placebo (240 mg 2 times a day plus 2 inactive placebo capsules once a day);

Group 2 will take 2 capsules orally, 3 times a day of high dose BG00012 (240 mg 3 times a day);

Group 3 will take 2 capsules orally, 3 times a day of placebo.

All patients who complete this study according to the protocol requirements may be enrolled into an extension study, in which all patients will receive BG00012.

Contact: For information on sites that are currently enrolling for the DEFINE study, please contactDEFINE@dandersoncompany.com. Sites will be located in the following cities:

Albany, NY Atlanta, GA Brighton, MA Dayton, OH Des Moines, IA East Providence, RI Erie, PA Evanston, IL Fort Wayne, IN Gilbert, AZ Hershey, PA Hopedale, MA Indianapolis, IN Las Vegas, NV Lebanon, NH Lexington, KY Lexington, MA Minneapolis, MN New Haven, CT Palos Heights, IL Phoenix, AZ Pittsburgh, PA Providence, RI Raleigh, NC Saint Louis, MO San Francisco, CA Seattle, WA Springfield, MA Vero Beach, FL Washington, DC Wichita, KS Wien, VA Worcester, MA

Details of CONFIRM:

The primary goal of the CONFIRM study is to determine whether BG00012 can decrease the rate of clinical relapses in comparison to both placebo and a currently used standard MS therapy, and whether the agent is safe and well tolerated. Secondary objectives include assessing the drug’s effects on reducing the proportion of relapsing subjects,, disability progression, disease activity detected by MRI and other measures.

Participants will be randomly assigned to one of four groups:

Group 1 will take 2 capsules orally, 3 times a day consisting of low dose BG00012 plus placebo (240 mg 2 times a day plus 2 inactive placebo capsules once a day);

Group 2 will take 2 capsules orally, 3 times a day of high dose BG00012 (240 mg 3 times a day);

Group 3 will take 2 capsules orally, 3 times a day of inactive placebo;

Group 4 will receive the standard dose of the approved therapy Copaxone.

Contact:

For information on sites that are currently enrolling for the CONFIRM study, please contact:CONFIRM@dandersoncompany.com. Sites will be located in the following cities:

Albuquerque, NM Amherst, NY Ann Arbor, MI Augusta, GA Baltimore, MD Bellevue, OH Bennington, VT Birmingham, AL Boston, MA Boulder, CO Buffalo, NY Burlington, VT Cedarhurst, NY Charlotte, NC Cleveland, OH Clinton Township, MI Colorado Springs, CO Columbus, OH Cordova, TN Cullman, AL Dallas, TX Dover, NH Eugene, OR Fort Collins, CO Freehold, NJ Galveston, TX Grand Rapids, MI Houston, TX Huntsville, AL Indianapolis, IN Kansas City, KS Knoxville, TN La Jolla, CA Lebanon, NH Lighthouse Point, FL Loma Linda, CA Louisville, KY Madison, WI Maitland, FL Maywood, IL Medford, OR Melbourne, FL Memphis, TN Meridian, ID Miami, FL Milwaukee, WI Missoula, MT Naples, FL Nashville, TN New York, NY Oklahoma City, OK Pasadena, CA Patchogue, NY Philadelphia, PA Phoenix, AZ Pittsburg, PA Plainview, NY Pompano Beach, FL Portland, OR Richmond, VA Round Rock, TX Sacramento, CA Saint Petersburg, FL Salt Lake City, UT San Antonio, TX San Francisco, CA Sarasota, FL Seattle, WA Shreveport, LA Staten Island, NY Stony Brook, NY Tacoma, WA Tallahassee, FL Tampa, FL Teaneck, NJ Walnut Creek, CA Winston-Salem, NC