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, CEL-SCI received verbal notice from the FDA that the Phase 3 clinical trial has been placed on clinical hold. On October 21, 2016, CEL-SCI issued a press release stating that, "following up on our press release issued on September 26, 2016, we have received the Partial Clinical Hold letter from the FDA. CEL-SCI is working on a response to the FDA and will work diligently with the FDA to seek to have the partial clinical hold lifted." Updated information on the partial clinical hold is available on CEL-SCI's Form 8-K filed with the SEC on December 22, 2016.
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.