That trial was designed to evaluate repifermin's safety in patients and provide initial information about dosing and effectiveness. The clinical trial program announced today is the next step in repifermin's clinical development as a treatment for chronic venous ulcers. Repifermin's Other Clinical Development Programs Human Genome Sciences 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. Human Genome Sciences is conducting a Phase II clinical development program to evaluate repifermin for mucositis in patients undergoing high-dose chemotherapy in preparation for bone marrow transplantation. This study is designed to test safety 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, but studies suggest that some patients are genetically predisposed.