New class of immunotherapy drugs

The investigational therapy Multikine® (Leukocyte Interleukin, Injection), a potential combination immunotherapy in what may become a new class of immunotherapy drugs

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.

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Multikine is an investigational immunotherapy currently under development for the treatment of head and neck cancer, and peri-anal warts or cervical dysplasia in HIV/HPV (human immunodeficiency virus / human papillomavirus) co-infected patients. It is considered to be in what may become a new class of immunotherapy drugs called combination immunotherapy based upon the following characteristics preliminarily evidenced in studies to date:

oPotential first-line treatment: Multikine is administered prior to any other 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.
oPotential to work with the body: Multikine investigational immunotherapy is directed at activating and possibly boosting the body’s own anti-tumor immune response to potentially help the body in addressing the tumor.
oA mixture of different immune molecules, potentially simulating the natural immune system: Multikine is composed of a defined mixture of naturally occurring molecules which in early-phase studies have been reported to be biologically/immunologically active.

Research at the U.S. 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

oPreliminary data from early clinical studies suggest Multikine has the potential to:
oAct on multiple receptors on the cancer cells.
oAct on multiple components of the immune response, and on the tumor cells themselves.
oActivate immune pathways known to be necessary for addressing the tumor.

* 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 involving summarized on this page or elsewhere on this website 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.

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