Potential Relevance of the Investigational Therapy Multikine® (Leukocyte Interleukin, Injection) to the Medical Community Responsible for Head and Neck Cancer Patients with Advanced Disease if Approved for Marketing by the FDA

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.

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 become weakened and may be less able to mount an anti-tumor immune response.

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. Current scientific leaders' in the field think that immunotherapy should be used early in the disease process and a combination of therapies may be needed to overcome cancer.

Potential Implications of First-Line Treatment:

Safety reports from Phase I and Phase II clinical trials (as reported by the clinical investigators): During the early investigational phase, in Phase I and Phase II clinical trials in over 220 subjects who received the investigational therapy Multikine in (daily) doses of 200 to 3200 IU as IL-2, no serious adverse events were reported as being expressly due to administration of this investigational therapy.  The most frequently reported adverse events included pain at the injection site, local minor bleeding and edema at the injection site, diarrhea, headache, nausea, and constipation. No "abnormal" laboratory results were reported following Multikine treatment - other than those commonly seen by treating physicians in this patient population - regardless of Multikine administration. Similarly, in these early-phase clinical studies in patients, there was no reported increased toxicity of follow-on treatments (as a result of Multikine administration). No complications following surgery (such as increased time for wound healing) were reported. No definitive conclusions can be drawn from these data about the safety or efficacy profile of this investigational therapy, and further research is required and ongoing in an effort to confirm these results.  Potential conclusions could only be drawn if the initial observations in the early-phase studies relating to the potential adverse events associated with Multikine administration and its potential efficacy in treating head and neck cancer are confirmed in the well controlled Multikine Phase III clinical study, CEL-SCI's Phase III efficacy study is completed successfully, and the FDA licenses the product following their review of all of the data related to Multikine submitted in CEL-SCI's license application. 

Potential effect on recurrence of cancer: Tumor cells can persist after treatment with radiation, chemotherapy and surgery. The persistence of these cells is thought to be responsible (at least in part) for cancer recurrence.  Multikine is injected around the tumor and in the vicinity of the local lymph nodes because these are the areas where metastases are believed to be most likely to develop and where the cancer may recur.  It is believed that the Multikine investigational treatment possibly could enable the immune system's to have a potential effect on those tumor cells before they can cause tumor recurrence.

Off the shelf product / does not need to be customized: The investigational Multikine therapy is mass-produced for clinical investigations under current Good Manufacturing Practices and is being developed as a potential ready-to-use anti-cancer immunotherapy for advanced primary head and neck cancer. As opposed to certain cancer vaccines, Multikine does not need to be customized or developed from the patient's own cancer, immune or other cells.

Multikine investigational therapy is developed in a dedicated manufacturing facility

Early-phase data suggests Multikine potentially has combination immunotherapy activity: it may have the potential to simultaneously present both active and passive properties to act against the cancer cells (Timar et al. Laryngoscope 2003 and JCO 2005). These combined activities, if confirmed, would seem to suggest that the activity of Multikine potentially could closely resemble the activity imparted by a healthy person's immune system, which can monitor for and take action against cancer cells.

One immunotherapy vs. a mixture of immunotherapies: The Multikine investigational therapy is a defined combination (mixture) of natural cytokines; each of its molecular components is present in similar proportions as would be seen if it were secreted directly by the cells of a person with a healthy immune system.  Thus the right combination (proportions) of the immunotherapeutic agents (cytokines) are believed to potentially be delivered in the Multikine investigational therapy.

If, following completion of CEL-SCI's large, global, well-controlled Phase III clinical trial and submission and FDA review of CEL-SCI's Multikine marketing application, this investigational therapy were to be approved for marketing, CEL-SCI would intend for it to be readily available as an "off-the-shelf" injectable preparation.

Potential role in multiple tumors to be explored in future R&D: Preliminary data from the ongoing clinical development program for the Multikine investigational therapy suggests that it may have a potential role in other cancers. Because the Multikine investigational therapy already has shown preliminary biological activity in very early-phase clinical studies in both cervical dysplasia/neoplasia and prostate cancer, CEL-SCI intends to pursue further R&D to investigate these potential roles in the future.

* 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.