CEL-SCI Corporation (NYSE AMEX: CVM) today announced that the Chinese patent office has issued a key patent covering CEL-SCI's investigational cancer drug, Multikine® (Leukocyte Interleukin, Injection). The patent, Chinese patent number ZL200480025403.6, is titled, "A Method of Pre-Sensitizing Cancer Prior to Treatment with Radiation and/or Chemotherapy and a Novel Cytokine Mixture".
This invention relates to a novel investigational therapy that CEL-SCI believes has the potential to be a method for pre-sensitizing cancer with Multikine (Leukocyte Interleukin, Injection) prior to a therapeutic treatment such as chemotherapy, radiation therapy or immunotherapy. Clinical studies conducted to date on CEL-SCI's investigational drug Multikine (Leukocyte Interleukin, Injection) indicate its potential to be able to induce cancerous cells' entry into the cell cycle phase thereby possibly increasing their vulnerability to chemotherapy and radiation therapy. Further research is required and underway in an effort to confirm these results. In the ongoing Phase III clinical study, Multikine (Leukocyte Interleukin, Injection) is administered to patients receiving this investigational therapy ahead of surgery, radiation and chemotherapy, in advanced primary (not yet treated) head and neck cancer.
Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent consisting of a mixture of naturally occurring cytokines, including interleukins, interferons, chemokines and colony-stimulating factors, currently being developed for treatment of head and neck cancer.
CEL-SCI's Phase III clinical trial is an open-label, randomized, controlled, multi-center study designed to determine if Multikine (Leukocyte Interleukin, Injection) administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Radiochemotherapy) used for treatment naive (yet untreated) subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival versus the subjects treated with standard of care only. It is the first trial in which immunotherapy will be administered before any other traditional means of care are attempted.