Emisphere Technologies Discloses the Completion of Enrollment in Second Phase III Study
Mon. June 08, 2009; Posted: 12:09 AM
PowerRating -- Emisphere Technologies, Inc. announced that Novartis Pharma AG and Nordic Bioscience have completed recruitment for the planned second 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 is intended to be used to support a regulatory filing in the U.S., includes more than 900 patients between the ages of 51 and 80 with a medical history and symptoms of knee osteoarthritis. The study is being conducted in Europe and the U.S., as well as other countries, and is a two year study.
In a release, the company noted:
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, when walking or standing. OA is the most common form of arthritis, and affects nearly 21 million people in the United States, accounting for approximately 15 percent of visits to primary care physicians. It is estimated that 80 percent of the population will have radiographic evidence of OA by age 65.
"We are pleased with the progress that has been made with this extensive Phase III program evaluating oral salmon calcitonin in combination with our Eligen drug delivery technology in osteoarthritis," said Michael V. Novinski, President and Chief Executive Officer of Emisphere. "The Eligen Technology has broad applicability and may help in the development of a safe, effective, and more convenient alternative to existing therapies for osteoarthritis."
Oral calcitonin is also being investigated using Eligen Technology in a Phase III study for osteoporosis.
Emisphere is a biopharmaceutical company that focuses on an improved delivery of therapeutic molecules or nutritional supplements using its Eligen Technology.
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