Introduction to Investigational Therapy Multikine® (Leukocyte Interleukin, Injection)

Multikine (Leukocyte Interleukin, Injection)* is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this page as Multikine.  Multikine is a potential new type of immunotherapy. It is combination immunotherapy (i.e., it has both active and passive immune activity). Multikine is currently under development as an investigational drug (in treatment of advanced primary head and neck cancer). Multikine has not been licensed or approved by the FDA or by any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data summarized on this page or elsewhere on this website involving this investigational therapy.

CEL-SCI believes combination immunotherapy has the potential to most closely resemble the workings of the natural immune system in the sense that it can possibly work on multiple fronts against advanced primary head and neck cancer.

Combination immunotherapy:

  o Is thought to have the potential to cause a direct effect on tumor cells; and  
       
  o Is thought to have the potential to activate the immune system to produce an anti-tumor immune response.  

Multikine investigational therapy is comprised of a mixture of cytokines; it is not one cell or one protein; it is a combination of molecules and proteins (interleukins, interferons, chemokines, and colony stimulating factors) derived from the stimulation in culture of normal immune system cells.

  o Multikine investigational therapy is a patented defined mixture of biologically active, natural cytokines, for which preliminary evidence from studies to date suggests the potential to simulate the body's healthy immune response.  
       
  o Cytokines are generally known to play a key role in regulating the body’s immune system.  
       
  o Multikine investigational therapy is not an autologous treatment, (it is not derived from and customized for the same patient). It is being developed and clinically studied as a ready-to-use, mass produced, off-the-shelf investigational therapy.  
       

* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved by the FDA or by any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data summarized on this page or elsewhere on this website involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.