Investigational Therapy Multikine® (Leukocyte Interleukin, Injection) Phase III Clinical Trial Design and Status

The Phase III Clinical Trial: Multikine (Leukocyte Interleukin, Injection) was cleared for a global Phase III trial in advanced primary head and neck cancer over 10 years ago. It received a go-ahead from 24 Regulatory Agencies worldwide including leading regulators in the U.S., Canada, France and the United Kingdom. Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, it 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.

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Because of Multikine’s orphan drug status in the USA, it currently is anticipated that only one pivotal study is expected to be necessary for Multikine’s approval. The indication for which Multikine was investigated as a potential treatment in the Multikine Phase III Study is advanced primary, not yet treated, squamous cell carcinoma (head and neck cancer), a recognized unmet medical need.

Nine hundred twenty-eight (928) newly diagnosed (and not yet treated) head and neck cancer patients were enrolled in this Phase III cancer study and all the patients who completed treatment were followed for protocol-specific outcomes in accordance with the Study Protocol. The last patient was enrolled in the study in September 2016. Approximately 135 patients were enrolled in the study from 2011 to 2013, about 195 were enrolled in 2014, about 340 in 2015, and about 260 in 2016.

Our global pivotal Phase III trial tested the hypothesis that Multikine treatment regimen administered prior to standard of care (SOC) for these patients, will extend overall survival, enhance the local/regional control of the disease and reduce the rate of disease progression in patients with squamous cell carcinoma of the head and neck, (SCCHN). SCCHN represents about 90% of all head and neck cancer. Current SOC for this indication is surgery, followed by radiation therapy alone or surgery followed by concurrent radio-chemotherapy (as defined by the National Comprehensive Cancer Network, or NCCN, guidelines) depending on the severity of the disease.

This study is also thought to be the first Phase III study in the world in which immunotherapy is given to patients first, after diagnosis and before any conventional treatment for cancer. It seems logical that boosting an intact immune system should be more helpful to patients than trying to boost a significantly weakened immune system after surgery, radiation and chemotherapy. Below is a general overview of the Phase III clinical trial.

Study Summary: A Pivotal Phase III, Open-label, Randomized, Controlled Multi-center Global Study of the Effects of Multikine Plus Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent Chemoradiotherapy) in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity and Soft Palate Versus Standard of Care Only.

Objectives: As set forth in the study protocol, the primary objective of this Phase III trial was to evaluate the efficacy of peri-tumoral and peri-lymphatic injection of the investigational Multikine therapy given prior to SOC. This was primarily evaluated based upon measurements of overall survival. The secondary objectives were to evaluate the effects of the investigational Multikine therapy on the cumulative incidence of local-regional control, progression-free survival, tumor histopathology, and quality of life, while also seeking to confirm Multikine safety in this patient population. Tumor response was a tertiary outcome in this immunotherapy study.

Number of Subjects Enrolled: 928

Clinical Centers: approximately 100 globally distributed; North America, Europe, Asia

For more information about the Phase III Study please see www.clinicaltrials.gov (NCT number: NCT01265849).

* 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 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.

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