- Thousand Oaks, Calif.
Amgen (Nasdaq: AMGN), announced today that rHu-KGF decreased the duration and incidence of severe oral mucositis in a phase 3 study of patients undergoing bone marrow transplantation treatment for hematologic malignancies such as lymphoma, multiple myeloma, and leukemia. Natural keratinocyte growth factor stimulates the growth and development of epithelial cells, including the cells that line the gastrointestinal tract. Amgen is studying a recombinant human keratinocyte growth factor (rHu-KGF) to protect epithelial cells from injury caused by anti-tumor treatments such as radiation and chemotherapy. Mucositis is a painful and debilitating condition in which patients experience severe mouth ulcerations that can make swallowing difficult or impossible. Preliminary results from the Phase 3 randomized, double blind trial were positive on all end-points showing highly significant decrease in both the duration and incidence of severe mucositis. The trial also showed that KGF was well tolerated. Roger Perlmutter, Amgen’s executive vice president of research and development, said: There is no currently approved therapy to treat oral mucositis, a sometimes devastating complication of cancer chemotherapy. We are looking forward to discussing our phase 3 results that address this critical unmet medical need with regulatory agencies in the near future. Amgen will now investigate the efficacy and safety of KGF in other patient populations who suffer from high rates of mucositis associated with their anti-tumor treatments.
OCF NOTE: OCF is excited about Amgen bringing this product to market and investigating is efficacy in the treatment of oral mucositis, a considerable problem for patients undergoing radiation or chemotherapy for the treatment of oral cancer.