What is the investigational therapy Multikine (Leukocyte Interleukin, Injection)?

Introduction to Investigational Therapy Multikine

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 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.

Multikine is an investigational immunotherapeutic agent being developed as a potential treatment for head and neck cancer, and peri-anal warts or cervical dysplasia in HIV/HPV (human immunodeficiency virus / and human papillomavirus) co-infected patients. The first indication we are pursuing for Multikine is an indication for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck, or SCCHN. In clinical studies conducted to date, and in our ongoing Phase III clinical trial, Multikine is administered prior to any other cancer therapy because it is generally accepted in the scientific community that this represents the period when the anti-tumor immune response still has the potential to be more fully activated. If it were to be approved for use following completion of our clinical development program, Multikine could be part of the next generation of cancer immunotherapy because:

  o It is being developed as an off-the-shelf investigational therapy making large scale manufacturing at a reasonable cost possible;  
       
  o It is being developed with both active and passive immunity, which means that no outside antigens are needed; and  
       
  o It is being studied for administration prior to surgery, radiation and chemotherapy, when the immune system may be more intact and thus with greater potential to be activated.  

Multikine investigational therapy has the potential to be a new type of immunotherapy. It is a defined mixture of cytokines (small proteins released by cells that have a specific effect on the interactions between cells). The cytokine mixture includes interleukins, interferons, chemokines, and colony stimulating factors; all of which are molecules which stimulate the body's healthy immune response.  Multikine belongs to a new class of experimental immunotherapy called combination immunotherapy (i.e., it has both active and passive immune activity).

Combination immunotherapy may have the potential to most closely resemble the workings of the natural immune system in the sense that it could work on multiple fronts to potentially elicit or activate a response against cancer. More...

CLINICAL TRIAL STATUS OF INVESTIGATIONAL THERAPY MULTIKINE

The first clinical development indication being pursued for this investigational therapy (Multikine) is as a potential first-line therapy for advanced primary head and neck cancer. This form of cancer is a deadly cancer with only about 50% or less survival at 3-5 years from diagnosis and represents a clear unmet medical need.

Current standard of care cancer therapies (surgery followed by radiation, chemotherapy or radio-chemotherapy - as recommended by the NCCN Clinical Practice Guidelines in Oncology; of issued by the National Comprehensive Cancer Network) cannot completely arrest the disease because they are unable to completely remove or kill all of the cancer cells.

The pivotal Phase III study for Multikine in head and neck cancer which is intended to support a subsequent marketing application and possible subsequent regulatory approval subject to FDA's review of our entire data set, started in late December 2010, but initially encountered enrollment problems following the purchase of the Clinical Research Organization (CRO) that was in charge of the Phase 3 study by a Private Equity owned CRO that was doing a roll-up of many CROs. These issues have successfully been addressed with new CRO management. More...

Investigational Therapy Multikine Phase III Clinical Trial Design

Following submissions to regulatory authorities in 24 countries around the world, including the FDA in the United States, a global Phase 3 clinical trial of the investigational Multikine therapy as a potential neoadjuvant therapy in patients with SCCHN was initially commenced in late 2010. This trial is expected to be the largest head and neck cancer clinical study ever conducted. More...

CURRENT KNOWLEDGE OF THE Mechanism of Action OF THE INVESTIGATIONAL THERAPY MULTIKINE

The current underlying understanding of Multikine's apparent mode of action, which presently is based on data from animal/human studies to date, is that it appears to activate the immune system to potentially mount an anti-tumor immune response against the specific individual tumor within each subject treated. More...

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

Potential first-line immunotherapy: Multikine is an investigational immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer.  In Phase I and Phase II clinical trials, and in the ongoing Phase III clinical trial, Multikine was/is being administered prior to any other cancer therapy because CEL-SCI believes that this is the period when there is a greater potential likelihood of activating an anti-tumor immune response.  Once the patient has had surgery or has received radiation and/or chemotherapy, the immune system may be weakened and may be less able to mount an anti-tumor immune response.

Multikine is given for three weeks following diagnosis, during the usual four weeks of scheduling the surgery. Therefore Multikine does not delay the standard of care therapies. It is clearly recognized by regulators and hospital review boards that it is not acceptable to delay the proven therapies to try new therapies.

To date, other immunotherapies have been administered later in cancer therapy (i.e., after radiation, chemotherapy, surgery). This potentially may be one of the reasons other immunotherapies may not have had the initially expected response. Currently, many scientific leaders in this field think that immunotherapy should be used early in the disease process and a combination of therapies may be needed to overcome cancer. More...

Head and Neck Cancer

This section is dedicated to helping you understand head and neck cancer, the first type of cancer for which the Multikine investigational therapy is being developed. The following is a selection of online information adapted from the website of the National Cancer Institute (http://www.cancer.gov, accessed September 28, 2007), which provides information about many types of cancer, information about clinical trials, resources for people dealing with cancer, and information for researchers and health professionals. More...

Cigarette Smoking and Cancer: Questions and Answers

Tobacco use, particularly cigarette smoking, is the single most preventable cause of death in the United States. Cigarette smoking alone is directly responsible for approximately 30 percent of all cancer deaths annually in the United States (1). Cigarette smoking also causes chronic lung disease (emphysema and chronic bronchitis), cardiovascular disease, stroke, and cataracts. Smoking during pregnancy can cause stillbirth, low birth weight, Sudden Infant Death Syndrome (SIDS), and other serious pregnancy complications (2). Quitting smoking greatly reduces a person's risk of developing the diseases mentioned, and can limit adverse health effects on the developing child. More...

 

* 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 in progress.