Research & Clinical Trials

At CEL-SCI, we are dedicated to changing the way cancer and other diseases are treated. 

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*.

CEL-SCI's research and development programs focus on utilizing immunotherapy to develop new therapies that have the potential to address the unmet medical needs of patients with cancer and infectious diseases. To that end, CEL-SCI has initiated a Global Phase III clinical trial of Multikine in patients with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity and soft palate (Head and Neck Cancer), a debilitating life-threatening disease, for which the overall five year survival rate has not materially improved over several decades.

On August 14, 2017, CEL-SCI announced that it has received a letter from the FDA stating that the clinical hold that had been imposed on the Company's Phase III cancer study with Multikine has been removed and that all clinical trial activities under this Investigational New Drug application, or IND, may resume.

Nine hundred twenty-eight (928) newly diagnosed head and neck cancer patients have been enrolled in this Phase III cancer study and all the patients who have completed treatment continue to be followed for protocol-specific outcomes in accordance with the Study Protocol. The study's primary endpoint is a 10% increase in overall survival for patients treated with the Multikine treatment regimen plus Standard of Care (SOC) versus those who receive SOC only. The determination if the study's primary end point has been met will occur when there are a total of 298 deaths in those two groups. Current SOC for this indication is surgery, followed by radiation therapy alone or followed by concurrent radio-chemotherapy.

For more information on Multikine's Phase III clinical trial design, please read Investigational Therapy Multikine Phase III Clinical Trial Design or you can also visit http://www.clinicaltrials.gov.

 

* 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 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.