Products in Development
Multikine® (Leukocyte Interleukin, Injection), or Multikine* -- an investigational immunotherapy under development for the potential treatment of certain head and neck cancers, and peri-anal warts or cervical dysplasia in human immunodeficiency virus, or HIV, and human papillomavirus, or HPV co-infected patients.
L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology, or LEAPS** -- has two investigational therapies, LEAPS-H1N1-DC, a product candidate under development for the potential treatment of pandemic influenza in hospitalized patients, and CEL-2000, a vaccine product candidate under development for the potential treatment of rheumatoid arthritis.
The following chart depicts our product candidates, their indications and their current stage of development:
Multikine, CEL-SCI's lead investigational immunotherapy, is an immunotherapeutic agent that is being developed as a potential first-line neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck, and potentially, as a treatment for peri-anal warts in HIV/HPV co-infected patients. If it were to be approved for use following completion of CEL-SCI's clinical development program, Multikine would be a different kind of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors.
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.
Multikine may also have the potential to be a first in a new class of cancer immunotherapy drugs. It is the first investigational combination immunotherapy thought to have both passive and active immune properties. More...
LEAPS is a patented, T-cell modulation, peptide epitope delivery technology that enables CEL-SCI to design and synthesize proprietary peptide immunogens. LEAPS compounds consist of a small T-cell binding peptide ligand linked with a disease-associated peptide antigen. This technology has been shown the potential in several animal models to preferentially direct immune response to a cellular (e.g., T-cell), humoral (antibody) or mixed pathway. Diseases for which antigenic epitope sequences have been identified, such as some infectious diseases, cancer, autoimmune diseases, allergic asthma and allergy, and select CNS diseases (e.g., Alzheimer's) may be potential candidates for development using this technology platform. More...
* 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 by any other regulatory agency. Similarly, its safety of 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.
** No LEAPS investigational therapy has been approved for sale, barter or exchange by the FDA or any other regulatory agency for any use to treat disease in animals or humans. The safety or efficacy of these products has not been established for any use. Lastly, no definitive conclusions can be drawn from these early-phase, preclinical-trials data involving these investigational products.