Coral Study Marks First Worldwide Trial For Oral MS Therapy

The first global study for an oral multiple sclerosis (MS) drug therapy has been launched at universities and medical centers worldwide to determine if an oral formulation of COPAXONE® is efficacious and safe for the treatment of relapsing-remitting MS. Dr. Jerry S. Wolinsky, professor of neurology at The University of Texas-Houston Health Science Center, is spearheading the effort.

An injectable formulation of the drug COPAXONE® (glatiramer acetate for injection) is one of three approved therapies in the United States to treat relapsing-remitting disease. All three treatment options are administered by injection.

The Coral Study is the largest clinical study for people with MS, spanning five continents and 18 countries. It will involve 178 study sites around the world, 58 of which are in the United States. Researchers are seeking to recruit 1,300 participants, including 600 to 700 Americans. The Coral Study will last 56 weeks.

"There is a great need for an oral medication for MS," says Dr. Wolinsky, chairman of the Coral Study's North American Clinical Steering Committee, director of the Multiple Sclerosis Research Group at The University of Texas-Houston Health Science Center and the medical school's first Bartels Family Professor of Neurology. "This study hopes to determine if oral COPAXONE® is safe and can reduce relapses."

MS affects approximately 1 million people worldwide and 350,000 people in the United States. Nearly 85 percent of those individuals have the relapsing-remitting form of the disease. Yet only 75,000 Americans currently take one of the three approved injectable therapies.

"An oral therapy is a significant development. Many people are uncomfortable self-injecting, so finding alternative methods of delivery are critical," Dr. Wolinsky says. "However, even if oral COPAXONE® proves to be efficacious and safe, commercial availability is several years away."

People with a confirmed diagnosis of relapsing-remitting MS who are interested in participating in the Coral Study can obtain more information by calling toll free 1-877-31CORAL. They also can talk to their physician regarding the benefits of participating in the study or about initiating therapy now with a currently approved treatment.

In clinical studies with injectable COPAXONE®, the most commonly observed adverse reactions were injection site reactions (redness, pain, inflammation, itching, or a lump at the site of injection), flushing, chest pain, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness. Injection site reactions were usually mild and most often did not require professional treatment.

The Coral Study is a Phase III clinical study. Phase III studies follow years of extensive research and are often the final step before a request is made to the Food and Drug Administration for approval to market the drug.

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©2006 Texas Medical Center

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