Phase III Study to Explore the Effects of Oral Calcitonin, a combination of Salmon Calcitonin and Eligen Delivery Technology on Knee Osteoarthritis Treatment
CEDAR KNOLLS, N.J., Sept. 22 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. (Nasdaq: EMIS) announced today that Novartis Pharma AG and Nordic Bioscience have completed recruitment for a multi-center Phase III study exploring the safety and efficacy of an oral formulation of salmon calcitonin using Emisphere's proprietary Eligen Technology to treat patients with osteoarthritis of the knee. This study, which will be used to support the filing with health authorities worldwide, includes more than 1,100 patients between 51 and 80 years old with a medical history and symptoms of knee osteoarthritis. The study will be conducted mainly in Europe and is estimated to complete second half 2010.
Osteoarthritis ("OA") is a clinical syndrome in which low-grade inflammation results in joint pain, caused by a wearing-away of cartilage that cushions the joints and the destruction or decrease of synovial fluid that lubricates those joints. As OA progresses, pain can result when the patient bears weight upon the joints, including walking and standing. OA is the most common form of arthritis, and affects nearly 21 million people in the United States, accounting for 25% of visits to primary care physicians, and half of all non-steroidal anti-inflammatory drug prescriptions. It is estimated that 80% of the population will have radiographic evidence of OA by age 65.
"The problems associated with osteoarthritis will escalate as the
population ages," said Michael V. Novinski, President and Chief Executive
Officer of Emisphere. "This Phase III study aims at demonstrating that ora
|SOURCE Emisphere Technologies, Inc|
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