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, 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 September 26, 2016, the FDA placed the Phase 3 clinical trial on partial clinical hold. Subject to the partial clinical hold, CEL-SCI is not be able to enroll any additional patients in the Phase 3 study unless FDA lifts the partial clinical hold. CEL-SCI is diligently continuing to work with the FDA to have the partial clinical hold lifted. CEL-SCI has been in a continuing dialogue with the FDA to try to resolve their questions and to supply them with supplemental information. In accordance with the partial clinical hold, CEL-SCI is continuing to follow the 928 patients enrolled in the study, and this includes following patients until the targeted 298 deaths between the 2 comparison groups is observed. This number of deaths is required to evaluate if the study's primary endpoint is achieved. Currently CEL-SCI is not looking to enroll any more patients. However, if CEL-SCI determines that it needs to enroll more patients in the Phase 3 study, it would not be able to do so unless FDA lifts the partial clinical hold and approves an amendment for the additional patients.

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 on Partial Clinical Hold by the US FDA.