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 potentially 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 for the potential treatment of certain head and neck cancers, and peri-anal warts or cervical dysplasia in human immunodeficiency virus, or HIV, and human papillomavirus, or HPV co-infected patients . 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, meaning 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.  
       
  o Multikine is a patented defined mixture of 14 pro-inflammatory human cytokines. Many cytokines are approved for use in the treatment of cancer and are/have been used extensively.  

Multikine Cytokines

  o CEL-SCI is using this proven concept (cytokines in the treatment of cancer) to develop a more successful and less toxic cancer therapy by using the following concepts:
  1. Multikine is administered locally, not systemically, in small supra physiological doses to avoid the serious toxicities previously seen with many cytokine treatments;
  2. Multikine is administrered while the immune system is still intact, with intent to improve the cure rate, while other cytokine treatment are generally used in recurrent cancer patients, and 
  3. Multikine combines cytokines in a manner similar to the way the body does it naturally as opposed to giving only one or two of them.
 
       
  o Research at the US National Institutes of Health has shown that the cytokines in Multikine (shown in red in the table) are the ones that are required to reject any tumor  
       
  o Injected for 3 weeks before any other cancer therapy around the tumor and near adjacent lymph nodes to stimulate the immune system to recognize the cancer cells and micro-metastases. Once the immune system is able to "see" the cancer, the still intact immune system does what it is meant to do - destroy the cancer.  
       
  o The goal is to kill the tumor micrometastases thought to be responsible for recurrence, thereby reducing cancer recurrence and increasing survival.  
       

* 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.