These wounds occur on the lower leg, and often take more than a year to heal. The study was designed to test the safety of repifermin in venous ulcer patients and provide initial information about dosing and effectiveness. HGS also is investigating intravenous repifermin for mucositis resulting from chemotherapy. Mucositis can result in painful swelling, ulceration and bleeding in the gastrointestinal tract that may limit the dose of cancer therapy. No effective treatment now exists.
Patients risk infection and can require hospitalization.
As high-dose chemotherapy regimens and combination chemotherapy and radiotherapy become more widely used, mucositis will become more common. HGS is conducting a Phase II clinical trial of repifermin for mucositis in patients undergoing high-dose chemotherapy in preparation for bone marrow transplantation. This study is designed to test safety in patients and gain a preliminary indication of how much of the product is needed to be effective. Ulcerative colitis is a relapsing and remitting chronic disease characterized by acute inflammation of the colorectal mucous membranes. The primary cause of the disease is unknown.