A randomized, double-blinded, placebo-controlled Phase I trial to determine the safety and induction of antibody response of an Interleukin-1beta vaccine (CYT013-IL1bQb) in type 2 diabetic patients

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SUN 839-872-Diabetes & Obesity Management
Clinical
Sunday, June 16, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SUN-871
Claudia Cavelti-Weder1, Katharina Timper*2, Eleonora Seelig2, Cornelia Keller1, Martin Osranek1, Patrik Maurer3, Gunther Spohn3, Jörg Willers3, Martin Bachmann3 and Marc Y Donath2
1University Hospital Zürich, Zürich, Switzerland, 2University Hospital Basel, Basel, Switzerland, 3CYTOS, Schlieren, Switzerland
Title: A randomized, double-blinded, placebo-controlled Phase I trial to determine the safety and induction of antibody response of an Interleukin-1beta vaccine (CYT013-IL1bQb) in type 2 diabetic patients

Authors: Claudia Cavelti-Weder, Katharina Timper (presenting author), Eleonora Seelig, Cornelia Keller, Martin Osranek, Patrik Maurer, Gunther Spohn, Jörg Willers, Martin Bachmann, Marc Y. Donath

Interleukin-1beta (IL-1beta) is a key cytokine involved in inflammatory illnesses including type 2 diabetes. We developed and evaluated the safety and induction of antibody response (ELISA and neutralizing antibody assay) of a novel vaccine against IL-1beta (CYT013-IL1bQb) in animal models and in a randomized, double-blinded, placebo-controlled Phase I trial in patients with type 2 diabetes.

Murine and simian preclinical trials showed prompt induction of IL-1beta antibodies upon vaccination. In the clinical study involving 48 type 2 diabetic patients, 6 staggered cohorts of 8 patients each (6 patients IL1bQb, 2 Placebo) were treated with stepwise increasing doses and number of injections at predetermined time points. CYT013-IL1bQb was safe and well-tolerated. IL-1beta-specific antibody responses could be observed in most patients after immunization with the vaccine. IL-1beta-neutralizing antibodies indicating the clinical relevance of the immune response, however, were only evident in the highest dose group. There was preliminary indication of in vivo activity in patients with neutralizing antibodies as apparent from decreased HbA1c and glucose levels. In summary, IL-1beta-vaccine may represent a novel treatment modality for the IL-1beta-dependent diseases such as type 2 diabetes.

Disclosure: PM: Employee, CYTOS Biotechnology AG. GS: Employee, CYTOS Biotechnology AG. JW: Employee, CYTOS Biotechnology AG. MB: Employee, CYTOS Biotechnology AG. MYD: Coinvestigator, CYTOS Biotechnology AG. Nothing to Disclose: CC, KT, ES, CK, MO

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm

Sources of Research Support: CYTOS Biotechnology AG