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| |  Regranex Approved In Canada For Diabetic Ulcer Treatment RARITAN, NJ -- March 1, 1999 -- The Health Protection Branch of Health Canada has approved Janssen-Ortho, Inc.’s Regranex(R) (becaplermin) 0.01% for the treatment of full thickness lower extremity diabetic ulcers. Diabetic foot ulcers are non-healing sores that extend to the subcutaneous tissue or beyond and are the leading cause of amputation among Canadians with diabetes. According to the Canadian Diabetes Association, it is estimated that 15 percent of the 1.5 million Canadians with diabetes will develop foot ulcers at some point over the course of their lives. Foot ulcers often go undetected since other ailments associated with diabetes -- such as nerve damage and visual and circulatory problems -- make it difficult for patients to feel or see the ulcer as it develops. These open sores often do not heal and may lead to serious complications, including severe infection, hospitalisation and, in some cases, amputation. Clinical trials have demonstrated that a once-daily topical application of Regranex Gel plus good ulcer care healed more diabetic ulcers than placebo gel plus good ulcer care. Good ulcer care practices, including initial sharp debridement (removal of dead tissue), daily dressing changes (moist dressings changed at a frequency to maintain a moist wound-healing environment), treatment of infection -- if present -- and pressure relief are required to achieve the best results with Regranex Gel. The active ingredient in Regranex Gel is becaplermin, a genetically-engineered platelet-derived growth factor that mimics a protein that occurs naturally in the body (such as PDGF-BB). The growth factor stimulates the migration of cells -- key to wound healing -- to the ulcer site, encouraging the patient's body to grow new tissue that helps heal these open wounds. Becaplermin is produced by recombinant technology in yeast cells and is not derived from blood. Regranex Gel has not been studied in superficial diabetic foot ulcers. It is contraindicated in patients with known skin cancers at the site of application. Regranex Gel should not be used on wounds that are stitched or stapled. A small percentage (two percent) of patients treated with Regranex Gel or placebo gel experienced a rash near the wound. It should not be used in patients sensitive to any components of this product.
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