CEL-SCI receives Chinese patent for Multikine cancer drug

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.

In Phase II clinical studies, subjects with locally advanced disease who received the investigational therapy Multikine (Leukocyte Interleukin, Injection) as first-line investigational treatment were observed to have demonstrated a 33% increase in overall survival rate as compared to the overall survival rate that was determined from a review of 55 trials of the same cancer population, which were reported (in the scientific literature) between 1987 and 2007. However, no definitive conclusions can be drawn from these data about the potential efficacy profile of this investigational therapy. Moreover, further research is required, and these results must be confirmed in a well-controlled Phase III clinical trial of this investigational therapy that is currently in progress. Subject to completion of that Phase III trial and FDA's review of our entire data set on this investigational therapy, CEL-SCI believes that these early-stage clinical trial results indicate the potential for this investigational therapy to be a breakthrough in the treatment of advanced primary head and neck cancer. The U.S. Food and Drug Administration also granted orphan drug status to Multikine (Leukocyte Interleukin, Injection) in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.