Anika Therapeutics Commences Clinical Trial For INCERT-S Anti-Adhesion Therapy Tuesday April 20, 12:28 pm ET
WOBURN, Mass.--(BUSINESS WIRE)--April 20, 2004--Anika Therapeutics, Inc. (Nasdaq:ANIK - News) today announced it has commenced a human pilot clinical trial to test the safety and effectiveness of INCERT®-S for the prevention of internal adhesions or scarring following spinal surgery. The trial, which will involve approximately 45 patients, will be conducted at two centers in the United Kingdom, The Wellington Hospital in London and the Royal National Orthopaedic Hospital in Stanmore. INCERT®-S is part of a potential family of bioabsorbable, chemically modified hyaluronic acid (HA) therapies in development at Anika. INCERT is designed to act as a barrier to prevent internal tissue adhesion and scarring following spinal, cardiac, pelvic or abdominal surgery. Such adhesions can lead to recurrent back pain, female infertility and intestinal blockage, sometimes necessitating costly second surgeries. Anika's family of potential adhesion prevention products is based on the company's proprietary modified HA technology, which alters the properties of HA to allow for longer duration in the body. By controlling these properties, Anika can design products for optimal performance in the intended application.
Designed for spinal surgeries such as discectomy, laminectomy or laminotomy, INCERT-S is the first of Anika's potential therapies to be tested in human clinical trials. The gel-like substance is applied to the incision site prior to surgical closure. There are a large number of spinal surgeries worldwide susceptible to the complications of post-surgical adhesions, including approximately 700,000 each year in the United States alone.
"Now that our OrthoVisc® therapy for osteoarthritis of the knee has been launched in the United States, we are focusing our energies on developing a pipeline of innovative products that will generate sustainable long-term growth for Anika," said Charles H. Sherwood, Ph.D., president and chief executive officer. "Our near-term product strategy centers on therapies derived from chemically modified HA, and commencement of this INCERT-S trial is an important step forward." |