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Carbylan BioSurgery, Inc. Completes Enrollment in Key Clinical Feasibility Study of Hydros and Hydros TA in Patients With Pain From Knee Osteoarthritis; Core Patent Issued


1/5/2011 7:07:54 AM

PALO ALTO, Calif., Jan. 5, 2011 /PRNewswire/ -- Carbylan BioSurgery, Inc. announced today the completion of patient enrollment in their double-blinded, multi-center COR1.0 feasibility trial to evaluate the safety and effectiveness of two products - Hydros and Hydros TA Joint Therapies - in patients with osteoarthritis of the knee. Hydros and Hydros TA are next generation viscosupplement and viscosupplement/steroid combination products.

"Hydros and Hydros TA are designed to offer patients suffering from knee osteoarthritis more effective and safer options for managing the pain associated with their disease, and potentially, may help to delay knee replacement surgery," said George Daniloff, President and CEO of Carbylan BioSurgery. "Carbylan's polymer technology platform uniquely enables products we believe are superior to existing viscosupplement technology."

The COR1.0 clinical trial is being conducted at eight clinical sites in Canada, Belgium, and The Netherlands. The trial is designed to evaluate the safety and efficacy of Hydros and Hydros TA compared with Synvisc-OneĀ®, the market leading viscosupplement. A total of 98 patients have been treated in the study and will be followed for six months post injection. Carbylan expects final results from the study in August 2011, with pivotal studies for FDA approval expected to follow.

"We are very pleased that patient enrollment in the COR1.0 study was completed ahead of schedule. We believe this reflects the high level of interest in our product concept from both physicians and patients," commented Marcee Maroney, Vice President of Clinical Affairs and Marketing at Carbylan. "There is a clear clinical need for a safe, fast-acting, long lasting therapy to treat the pain associated with osteoarthritis of the knee. We believe that Hydros and Hydros TA are particularly well positioned to address this need."

In addition, Carbylan announced that on November 9, 2010 the US Patent Office issued a key Carbylan patent covering novel modified hyaluronic acid polymer compositions and methods (US Pat. 7,829,118). This patent protects the composition of matter for Hydros and Hydros TA as well as the proprietary chemistry used to trap the steroidal suspension inside the hydrogel component for Hydros TA from generic competition until 2030.

About Hydros and Hydros TA Joint Therapies

Hydros Joint Therapy ("Hydros") is an intra-articular injection therapy comprised of non-animal sourced hyaluronic acid (HA) which is chemically modified to form hydrogel beads. Hydros is biodegradable and resides in the joint for up to thirty days and is expected to provide sustained pain relief for up to six months with a single injection. Traditional viscosupplements are cleared from the joint in less than a week. Hydros TA Joint Therapy ("Hydros TA") is a novel dual mode viscosupplement which traps 10mg of triamcinolone acetonide (corticosteroid) inside the Hydros hydrogel beads. Hydros TA is expected to provide faster acting, longer lasting pain relief than either viscosupplements or steroids alone. Hydros TA allows for sustained local delivery of a low dose steroid reducing the risk of systemic steroid exposure and the potential cartilage degradation associated with steroid injections in the knee. There is currently no similar viscosupplement/steroid combination product available to treat the pain associated with osteoarthritis.

About Osteoarthritis

Osteoarthritis (OA), also known as degenerative arthritis or degenerative joint disease, is a group of mechanical abnormalities involving degradation of joints. Knee osteoarthritis is the most common type of osteoarthritis. More than 10 million Americans have knee osteoarthritis. It is also the most common cause of disability in the United States.

About Carbylan BioSurgery

Carbylan was founded in 2005 to develop and market medical devices and device/drug combination products based on novel chemically engineered polymer systems incorporating hyaluronic acid, a well known polysaccharide widely present in the human body. Its initial market focus is therapeutic medical devices and combination products to treat the pain associated with osteoarthritis. Carbylan biopolymers are biocompatible, non-immunogenic and, when combined with pharmaceutical agents, uniquely enable controlled, sustained local drug delivery.

SOURCE Carbylan BioSurgery, Inc.


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