Tuesday April 25, 8:03 am Eastern Time
Company Press Release
SOURCE: Teva Marion Partners
KANSAS CITY, April 25 /PRNewswire/ -- The first global study for an oral multiple sclerosis drug therapy has launched at universities and medical centers worldwide to determine if an oral formulation of COPAXONE® (glatiramer acetate for injection) is efficacious and safe for the treatment of relapsing-remitting MS.
COPAXONE® 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, 57 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," said Jerry S. Wolinsky, M.D., 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 glatiramer acetate tablets are safe and can reduce relapses."
MS affects approximately one 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 is critical," Dr. Wolinsky said. "However, even if oral glatiramer acetate 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 COPAXONE® (glatiramer acetate for injection), 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 randomized, double-blind, placebo-controlled study designed to determine if an oral formulation of COPAXONE® is efficacious, safe, and tolerable. Participants will receive a daily dose of one of the following: 50 mg of oral glatiramer acetate, 5 mg of oral glatiramer acetate, or matching placebo.
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 (FDA) for approval to market a drug.
Teva Marion Partners along with Teva Pharmaceutical Industries, Ltd., the marketer and manufacturer of COPAXONE®, respectively, are sponsoring the Coral Study. The companies are committed to improving the lives of people with MS and are investing millions of dollars in research and development during the next two years.
Teva Pharmaceutical Industries, Ltd. (Nasdaq: TEVA - news) was granted clearance by the FDA in December 1996 to market COPAXONE® (glatiramer acetate for injection) for the treatment of relapsing-remitting MS. COPAXONE® is marketed in the United States by Teva Marion Partners, based in Kansas City, Mo. Teva Marion Partners currently has 150 total associates in North America.
SOURCE: Teva Marion Partners