Diamyd Medical today announced that DIAGNODE-1, an open-label clinical pilot study in which the diabetes vaccine Diamyd is administered directly into lymph nodes, has been approved by the Swedish Medical Products Agency and the Ethics Review Board to be expanded from five to nine patients and to include children from 12 years of age.

Professor Johnny Ludvigsson, principal investigator and sponsor of DIAGNODE-1, has submitted a first preliminary evaluation of data from the first four patients that have been monitored for six months in the study, as an abstract for the diabetes meeting “51st Annual Meeting of the Scandinavian Society for the Study of Diabetes (SSSD)” to be held in Reykjavik, Iceland, on April 21-22, 2016. This evaluation preliminarily shows that the treatment appears to be safe and tolerable. Even if the clinical progression in patients shows certain positive data in terms of the body’s own capacity to produce insulin, as well as better long-term blood sugar and lower insulin dose (please see press release issued on February 11, 2016), no conclusions are drawn regarding metabolic parameters in these few patients who still may be in the so called honeymoon-phase, often characterized by some regression of the disease.

This data has served as the basis for an application to expand the study from five to nine participants and also to include children and adolescents from 12 years of age. This application has now been approved by the Swedish Medical Products Agency and the Ethics Review Board.

“This is a step forward for this new innovative treatment concept; to be able to study more but also younger patients where the value of immune intervention to save residual insulin secretion is deemed the most important,” says Professor Johnny Ludvigsson at Linköping University, principal investigator and sponsor of the study.

The pilot study DIAGNODE-1 is the first study of its kind, where a low dose of Diamyd® is administered directly into lymph nodes in combination with treatment with vitamin D. The concept, for which Diamyd Medical has submitted a patent application, can be compared to the development in allergy therapy, where the administration of allergen into lymph nodes has significantly improved efficacy, while concurrently decreasing the dose. Vitamin D is provided in order to down regulate the immune system’s inflammatory components to thereby increase the diabetes vaccine’s tolerance inducing effect with the aim of preserving the patient’s insulin producing capacity.

DIAGNODE-1 is an open pilot study which after this approval comprises a total of nine patients between the ages of 12 and 30 who have been diagnosed with type 1 diabetes in the past six months. The patients are monitored for 30 months. All participants are given a low dose (4µg) of Diamyd® into a lymph node on three occasions, in combination with intake of vitamin D.