Carticept Medical Reports First Patients Treated in Pivotal Study of Agilus™ Therapy for Pain Associated with Ankle Osteoarthritis

Business Wire,  May 14, 2008  

Tags: Columbus, Pivotal Corp., therapy

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ALPHARETTA, Ga. -- Sixth graph, second sentence of release should read: The first patients were treated at Pinnacle Research in Royal Palm Beach, Florida and the Orthopedic Foot and Ankle Center in Columbus, Ohio. (sted The first patients were treated at The University of Missouri, Columbia School of Medicine and the Orthopedic Foot and Ankle Center in Columbus, Ohio).

The corrected release reads:

CARTICEPT MEDICAL REPORTS FIRST PATIENTS TREATED IN PIVOTAL STUDY OF AGILUS(TM) THERAPY FOR PAIN ASSOCIATED WITH ANKLE OSTEOARTHRITIS

Carticept Medical, Inc., a developer of innovative products for the treatment of cartilage injuries and osteoarthritis, today announced that the first patients have been treated in a national, multi-center study of the Company's Agilus(TM)therapy. The study aims to determine whether Agilus is superior to saline-control in reducing the debilitating pain associated with ankle osteoarthritis (Ankle OA). If Agilus is proven to be safe and effective, it could provide a new option for people with Ankle OA for whom current therapies are inadequate or who want to delay or potentially avoid surgery.

Agilus, a high molecular weight, highly purified hyaluronan, represents an investigational application of a proven treatment approach called viscosupplementation, which has been used safely and effectively over many years for osteoarthritis of the knee.

"Commencing patient treatment is a noteworthy milestone for the Agilus trial and for Carticept, as we progress toward our goal of making this therapy commercially available to our first target patient population--those suffering from the debilitating pain of ankle osteoarthritis," said Timothy J. Patrick, president and chief executive officer. "Viscosupplementation therapies have been available for years to treat pain in the larger joints but, unlike these earlier treatments, Agilus was specifically designed to optimize performance in mid-size and small joints. We believe its formulation is ideal not only for the ankle, but potentially for other joints in the foot and hand."

An estimated two million people in the United States alone suffer from osteoarthritis of the ankle, a condition that is usually caused by previous trauma to the joint. While not as common as osteoarthritis of the knee, ankle osteoarthritis may be more limiting to the patient. According to published studies, if the pain of Ankle OA leads to a sedentary lifestyle, the permanent inactivity can place sufferers at elevated risk for unhealthy weight gain and cardiovascular disease. For many of these patients, currently available therapies and surgical procedures are not viable treatment options.

"Osteoarthritis of the ankle is a significant and debilitating problem for millions of patients worldwide," said Judith F. Baumhauer, MD, Associate Chair of Academic Affairs and Professor, Division of Foot and Ankle Surgery, Department of Orthopaedics at the University of Rochester and principal investigator of the Agilus trial. "For many patients with ankle osteoarthritis, there is a significant void in the current treatment armamentarium that Agilus could potentially address. We are excited to be able to participate in such an important study."

Carticept expects to enroll 380 patients at 20 sites throughout the United States. The first patients were treated at Pinnacle Research in Royal Palm Beach, Florida and the Orthopedic Foot and Ankle Center in Columbus, Ohio.

Additional information on the Agilus clinical trial can be found at www.anklestudy.com or by calling (877) 978-8397 toll free.

Caution: Agilus(TM) is an investigational device and exclusively for clinical investigation in the United States.

About Agilus(TM)

Agilus(TM) is a high molecular weight (2.0 to 3.0 million Daltons) highly purified hyaluronan, also known as hyaluronic acid (HA) or sodium hyaluronate. HA is a naturally occurring substance that is a major component of synovial fluid, a lubricant that reduces the friction between articular cartilage and other tissues in joints and acts as a shock absorber during movement. In osteoarthritis, there is a decrease in the hyaluronan concentration in the synovial fluid, reducing its viscosity and elasticity. Supplementing the joint's native hyaluronic acid with intra-articular injections of HA, a procedure known as viscosupplementation, can restore the synovial fluid's ability to cushion, lubricate and protect joints damaged by osteoarthritis. Viscosupplementation has been shown to relieve pain in many patients who cannot get relief from or are unable to tolerate analgesic drugs.

Agilus (1% sodium hyaluronate) is manufactured in the United States through a proprietary, microbial fermentation process. This process, free of any animal proteins, results in a finished product of high purity. Unlike the majority of hyaluronic acid products currently marketed in the United States for osteoarthritis, Agilus is not made from rooster combs, eliminating the potential for an allergic response in patients with sensitivity to avian products (such as feathers, eggs or poultry).