Elios Therapeutics, LLC
Elios Therapeutics, LLC is a single purpose, Texas based entity with the mission of conducting a randomized, placebo controlled, double blinded phase II (b) trial for stage III and IV (resected) melanoma patients. These patients typically have a 60-70% chance of recurrence. There is currently no non-toxic effective therapy for treating patients that are at a particular time clinically disease free. The Elios vaccine creates and effective immune response to a patient’s specific disease and is non-toxic, making it an appropriate therapy in the preventative setting.
The Elios technology being tested in this trial (NCT#02301611) is the next development stage of one of the work of one of the world’s leading immunologists, Thomas Wagner, PhD. Dr. Wagner has been studying cancer for over 50 years. The last 15 years of his work has been focused on directing the immune system to identify and eliminate cancer cells. The Elios vaccine’s phase II (b) trial is based on clinical success in phase I and II trial conducted between 2000 and 2009.
The Elios immunotherapy is a dendritic cell based vaccine that uses a novel method to deliver the entire antigenic and molecular profile of a patient’s disease to the immune system. This delivery method places the disease profile into the cytoplasm of the dendritic cell. When these completely educated dendritic cells are reintroduced to the patient through an intradermal injection, they create a strong “Killer T-Cell” immune response. Not only is the response effective, but it is also non-toxic allowing for the administration of the vaccine in the preventative (adjuvant) setting. Elios leadership is convinced that this setting is the most appropriate for a vaccine.
George Peoples, MD, FACS, Elios Therapeutics’ Chief Medical Officer, has structured the trial to prove the effectiveness of the Elios vaccine to prevent recurrence in late stage but clinically disease free patients, and has assembled many of the top melanoma centers in the country as participating sites, including the lead site for the trial, John Wayne Cancer Center in Santa Barbara, CA.
The trial began enrolling in January 2015, and will admit 120 stage III or stage IV (resected) to study the effect of recurrence for a two year period. These are patients that, once their tumor has been removed, they are clinically disease free at that time, but have a high likelihood of having remaining microscopic disease, which would lead to a recurrence within two years.
The Elios vaccine has shown to be effective in this setting in earlier clinical studies, and because of its very attractive safety profile can be administered without significant side effects in a preventative setting.