The Investigational Therapy Multikine (Leukocyte Interleukin, Injection)* as a potential treatment of Human Papilloma virus (HPV) caused diseases in HIV infected patients:
HPV is the most common sexually transmitted disease. The U.S. Center for Disease Control and Prevention (CDC) has named HPV the 4th largest health threat the U.S. will face in 2014. According to the CDC, about 360,000 people in the U.S. get genital warts each year. Persistent HPV infection in the anal region is thought to be responsible for anal warts and for up to 80% of anal cancers. HPV is an even more significant health problem in the HIV infected population as individuals are living longer as a result of greatly improved HIV medications, but are mostly unable to clear HPV due to their weakened immune system. The current treatments for these immune suppressed patients are not considered to be effective.
CEL-SCI using Multikine for the treatment of peri-anal warts in HIV/HPV co-infected men and women:
The U.S. Navy and CEL-SCI signed a CRADA (Collaborative Research and Development Agreement) in the fall of 2013. Pursuant to this agreement, the US Naval Medical Center, San Diego was going to conduct a Human Subjects Institutional Review Board approved Phase I dose escalation study of CEL-SCI's investigational immunotherapy Multikine in HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI would contribute the investigational study drug Multikine and would retain all rights to any currently owned technology and would have the right to exclusively license any new technology developed from the collaboration.
In July 2015, CEL-SCI added a site at the University of California, San Francisco, or UCSF, and Key Opinion Leader, or KOL, to the ongoing Phase 1 study. In August 2016, the U.S. Navy discontinued this Phase 1 study because of difficulties in enrolling patients. UCSF is continuing with the study.
The purpose of this dose escalation study is to evaluate the safety and clinical impact of Multikine as a treatment of peri-anal warts and assess the effect on anal intraepithelial dysplasia/neoplasia (AIN) in HIV/HPV co-infected men and women. Five participants will be treated with Multikine injections around the peri-anal warts at the lower dose for 5 days/week for 2 weeks, off 2 weeks, then 5 days per week for two more 2 weeks. If no serious adverse events are noted, 10 more patients will receive the higher dose of Multikine in the same manner. The study is open to adult HIV positive men and women that are eligible for medical care.
Multikine is being given to the HIV/HPV co-infected patients with peri-anal warts because promising early results were seen in another Institutional Review Board approved Multikine Phase I study conducted at the University of Maryland. In this study, investigational therapy Multikine was given to HIV/HPV co-infected women with cervical dysplasia resulting in visual and histological evidence of clearance of lesions. Furthermore, elimination of a number of HPV strains was determined by in situ polymerase chain reaction (PCR) performed on tissue biopsy collected before and after Multikine treatment. As reported by the study investigators, the study volunteers all appeared to tolerate the treatment with no reported serious adverse events.
* 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 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.
L.E.A.P.S.(TM)** (Ligand Epitope Antigen Presentation System) is a patented, T-cell modulation, peptide epitope delivery technology that enables CEL-SCI to design and synthesize proprietary peptide immunogens. L.E.A.P.S.(TM) compounds consist of a small T-cell binding peptide ligand linked with a disease-associated peptide antigen.
This technology has been shown 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) are potential candidates for development using this technology platform. More...
No L.E.A.P.S. product 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.
** L.E.A.P.S. is the trademark of CEL-SCI for this investigational platform technology, and this proprietary name is subject to FDA review.