CEL-SCI's Multikine cancer drug receives key Japanese patent

CEL-SCI Corporation (NYSE MKT: CVM) today announced that the Japanese patent office has issued a key patent covering CEL-SCI's investigational cancer drug, Multikine (Leukocyte Interleukin, Injection). The patent, Japanese patent number 5,122,279, is titled, "A Method of Pre-Sensitizing Cancer Prior to Treatment with Radiation and/or Chemotherapy and a Novel Cytokine Mixture". Key patents on Multikine have now been issued in the largest pharmaceutical markets in the world: the United States, European Union, China and Japan.

This invention relates to a novel effect of Multikine observed during clinical trials that CEL-SCI believes indicates it has the potential to pre-sensitize cancer cells to a therapeutic treatment such as chemotherapy, radiation therapy or immunotherapy. Phase I and II clinical studies with Multikine demonstrated that Multikine induced cancerous cells to enter into the cell cycle phase, and thereby possibly increased their vulnerability to chemotherapy and radiation therapy. Further research is required and currently underway in CEL-SCI's Phase III clinical trial in an effort to confirm the observed potential synergies of Multikine.

In CEL-SCI's ongoing Phase III global trial, advanced primary (not yet treated) head and neck cancer subjects randomized to Multikine treatment are administered Multikine ahead of surgery, radiation and chemotherapy, in the same way as it was given during CEL-SCI's Phase I and II trials. A recent interim review of the safety data from the Phase III trial by an Independent Data Monitoring Committee (IDMC) raised no safety concerns. The IDMC also indicated that no safety signals were found that would call into question the benefit/risk of continuing the study. CEL-SCI considers the results of the IDMC review important since the findings from this interim review were similar to those reported by investigators during CEL-SCI's Phase I-II trials in which the potential synergistic effects of Multikine on radiotherapy and chemotherapy were observed.

Head and neck cancer accounts for about 6% of the world's cancer cases, for a total of about 650,000 new cases every year and is associated mainly with excessive alcohol and tobacco use. Many head and neck cancers are also associated with and are thought to be caused by the Human Pappiloma Virus (HPV), the same virus that causes cervical cancer.

Multikine, an investigational immunotherapeutic agent consisting of a mixture of naturally occurring cytokines, including interleukins, interferons, chemokines and colony-stimulating factors, is currently being developed for treatment of head and neck cancer.

Multikine is the first immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer. If it were to be approved for use following completion of the Company's clinical development program, Multikine would become an additional and different kind of therapy in the fight against cancer: one that employs the body's natural ability to fight tumors.