Cel-Sci to bump standard of care in head, neck cancer
Source: www.bioworld.com Author: Catherine Shaffer Cel-Sci Corp. began a carefully designed Phase III trial of Multikine, its investigational immunotherapy for head and neck cancer. Because Multikine is designed to recruit the support of a mostly healthy immune system, Cel-Sci is making a headlong charge at the goal of first-line therapy, instead of trying to develop the product in patients who have already received surgery, radiation and chemotherapy, and have suppressed or damaged immune systems as a result. If Cel-Sci can prove the therapy works in the narrow three-week testing window granted by the FDA, Multikine stands to replace a standard of care that has changed little in half a century. "It makes no sense to develop an immunotherapy product for late-stage patients. You should develop it as a first line therapy, ahead of radiation or chemotherapy," Cel-Sci CEO Geert Kersten told BioWorld Today. Vienna, Va.-based Cel-Sci's clinical trial plan takes advantage of a nearly inevitable delay of up to six weeks between diagnosis and surgery in most head and neck cancers. The FDA has allowed Cel-Sci a three-week period to give Multikine to patients before they commence with surgery, radiation, and chemotherapy. This will not deprive any patients of the best possible standard-of-care while they also try an experimental therapy. Head and neck cancer strikes about 500,000 people annually worldwide. Some causal factors include smoking, drinking and chewing tobacco. Most cases are diagnosed outside the U.S., and about two-thirds of patients appear with advanced disease. The standard treatment for it [...]