Human Genome Sciences selected repifermin for development as a drug because of its potential to promote healing of skin wounds and internal wounds of the mucous membranes that line the gastrointestinal tract. In laboratory studies, repifermin contributed to healing of injuries to tissues containing keratinocytes and fibroblasts, including skin wounds, intestinal ulcers and other ulcers of mucous membranes. Used to treat full-thickness skin wounds, it completely restored normal skin tissue. Venous Ulcers Venous ulcers are lesions on the skin of the ankle or lower leg and can take more than a year to heal. They are caused by chronic venous insufficiency, which leads to pooling of blood in the extremities, causing swelling, or edema, and mild redness and scaling of the skin, often over a varicose vein.
Ulceration gradually develops as the skin becomes inflamed.
Current therapy protocols for these wounds include compression dressing, management of infection and debridement and may involve skin substitutes. However, treatment often extends for several months and frequently ends without success. Venous leg ulcers are responsible for more than half of lower extremity ulcerations, with an overall prevalence ranging from 0.06 to 2 percent. This variance may be due a number of contributory factors including the often inaccurate assessment of ulcer duration, healing and recurrence. In the United States, it is conservatively estimated that 400,000 to 600,000 patients suffer from venous ulcers each year.