As a result of these consequences, mucositis is considered to be a significant dose-limiting toxicity of radiation and chemotherapy. We are hopeful that the encouraging preclinical results seen with Repifermin will translate into clinical efficacy and provide a solution to a major dose-limiting toxicity of radiation and chemical therapies for cancer. Phase I human clinical studies have shown that systemically administered Repifermin is safe and well tolerated in healthy human subjects at doses proposed for subsequent clinical studies. None of the subjects withdrew from the study or required dose modification because of adverse effects. HGS scientists believe that Repifermin is a naturally occurring growth factor in the human body and is activated when there is an epithelial tissue wound.
Epithelial cells make up almost one-third of all the human body's cells.
Though best known as the major cell type in the skin, they also make up the lining of the mouth, throat, gastrointestinal tract and several other organs. Repifermin may work by attracting fibroblasts, collagen and connective tissues to the site of the wound to heal it through the creation of new tissue. In mucositis, Repifermin causes the creation of new mucosal tissue. We hope that this drug will treat a significant side-effect experienced by many cancer patients. HGS discovered Repifermin through its functional genomics program, a systematic review of thousands of full-length genes.