Cancer - The 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*.

CEL-SCI's lead investigational therapy Multikine is currently being developed as a potential therapeutic agent directed at using the immune system to produce an anti-tumor immune response. Data from Phase I and Phase II clinical trials suggest that Multikine may simulate a healthy person's immune system, enabling it to use the body's own anti-tumor immune response. If it were to be approved for use following completion of our clinical development program, Multikine would be a different kind of therapy in the fight against cancer: one that is designed with the intent to employ our body's natural ability to fight tumors. CEL-SCI is currently conducting a large Phase III clinical study with Multikine in head and neck cancer patients with advanced disease who are treatment na´ve (i.e., have received no prior treatment).

On September 26, 2016, the FDA placed the Phase 3 clinical trial on partial clinical hold. Subject to the partial clinical hold, CEL-SCI is not be able to enroll any additional patients in the Phase 3 study unless FDA lifts the partial clinical hold. CEL-SCI is diligently continuing to work with the FDA to have the partial clinical hold lifted. CEL-SCI has been in a continuing dialogue with the FDA to try to resolve their questions and to supply them with supplemental information. In accordance with the partial clinical hold, CEL-SCI is continuing to follow the 928 patients enrolled in the study, and this includes following patients until the targeted 298 deaths between the 2 comparison groups is observed. This number of deaths is required to evaluate if the study's primary endpoint is achieved. Currently CEL-SCI is not looking to enroll any more patients. CEL-SCI will not be able to enroll any additional patients in the Phase 3 study unless FDA lifts the partial clinical hold.

The current standard of care for initial treatment of these patients according to the NCCN guidelines (published by the National Comprehensive Cancer Network) is surgery followed by radiotherapy or surgery followed by combined radiochemotherapy - depending on pathology assessment of the resected tumor following surgery. In CEL-SCI's ongoing study, Multikine is administered to patients before these other treatments are given. At the completion of CEL-SCI's clinical development program, if the results indicate that this investigational therapy met its pre-specified endpoints, a Biologics License Application will be prepared and submitted to the FDA by CEL-SCI.

Multikine has the potential to be the first of a new class of cancer immunotherapy drugs. It is thought to be the first known combination immunotherapy, possessing both active and passive properties.

Multikine is designed to directly affect both the tumor cells themselves and activate an anti-tumor immune response. Read more about Multikine

CEL-SCI's business strategy is to create genuinely new and innovative therapies that meet unmet medical needs, as opposed to minor innovations to existing therapies or 'me-too' products.

In order to truly understand the potential for Multikine to be an innovative immunotherapy product, we invite you to read a brief summary of the field of cancer immunotherapy, which briefly summarizes the different therapies in this field.

  o Introduction to Cancer Immunotherapy  
  o Types of Biological Cancer Immunotherapy  
  o Passive Immunotherapy  
  Monoclonal Antibodies (mAbs)  
> Limitations of mAbs  
  o Active Immunotherapy  
  Cancer Vaccines  
> Limitations of Cancer Vaccines  
  Cellular Therapies  
> Limitations of Cellular Immunotherapies  
> Limitations of Adjuvant Immunotherapies  
  o Investigational Combination Immunotherapy  
  Multikine Investigational Therapy  
  o Limitations of Current Immunotherapies  
  o What is the Investigational Therapy Multikine?  
  o Introduction to Investigational Therapy Multikine  
  o Multikine has the potential to be in a new class of immunotherapy drugs  
  o Clinical Trial Status of Investigational Therapy Multikine  
  o Investigational Therapy Multikine Phase III clinical trial design  
  o Current Knowledge of the Mechanism of Action of the Investigational Therapy Multikine  
  o Potential Relevance of The Investigational Therapy Multikine to the Medical Community Responsible for Head and Neck Cancer Patients with Advanced Disease if Approved for Marketing by the FDA  
  o Head and Neck Cancer  
  Key Points  
  Questions and Answers  
> Cigarette Smoking and Cancer: Q&A  
  Related Resources  



* 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 for sale, barter or exchange 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 on Partial Clinical Hold by the US FDA.