Diamyd Medical announces that the first six-month interim report from DIAGNODE-1, a clinical pilot study in which the diabetes vaccine Diamyd is administered directly into lymph nodes, preliminarily shows that the treatment appears to be safe and tolerable and that the clinical progression in patients is positive in terms of the body’s own capacity to produce insulin, as well as long-term blood sugar and insulin dose.
This preliminary evaluation was submitted by Professor Johnny Ludvigsson, principal investigator and sponsor of the study, as an abstract for the SSSD diabetes meeting to be held in Reykjavik in April 2016.
DIAGNODE-1 is a clinical pilot study in young adults with type 1 diabetes in which a low dose of the diabetes vaccine Diamyd is injected directly into lymph nodes. The treatment is combined with orally administered vitamin D. The initial preliminary data is being presented from four patients that have been monitored for six months since inclusion in the study, meaning five months after the first of three injections of the diabetes vaccine Diamyd (4µg per dose) was administered directly into the lymph nodes. This new, method of administration is in analogy to the development in allergy therapy, where administration of allergen into lymph nodes significantly improved the efficacy. 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.
Professor Johnny Ludvigsson reports that the preliminary data for the four patients, with an average age of 21.8, who have been monitored for six months indicates good safety and no serious side effects have been reported. HbA1c (a way of measuring long-term blood sugar) decreased in all four patients. The insulin dose was reduced in three of the four patients. Over the six-month period the body’s own ability to produce insulin (measured as C-peptide, AUC) increased in two of the patients by 32 and 6 percent respectively, and decreased in two of the patients by 29 and 2 percent, respectively. On average, the group increased its ability to produce insulin by 2 percent, while HbA1c and insulin dose decreased by 32 and 25 percent, respectively.
Immunological parameters were also preliminarily evaluated, which showed a clear effect on the immune response compared with other studies in which the diabetes vaccine Diamyd® was injected subcutaneously with a higher dose, instead of a low dose injected directly into the lymph nodes, as in this study.
Professor Johnny Ludvigsson submitted an abstract with these interim results to the “51st Annual Meeting of the Scandinavian Society for the Study of Diabetes (SSSD)”, in Reykjavik, Iceland, which will be held on April 21-22, 2016.
“Although the study is very small and the data that we are now presenting after only six months is preliminary, the results appear positive,” says Professor Johnny Ludvigsson at Linköping University, principal investigator and sponsor of the study. “Perhaps we have succeeded in extending the remission phase for these young patients. My conclusion in the abstract that I sent to the SSSD meeting is that a low dose of the diabetes vaccine Diamyd administered directly into lymph nodes, combined with oral vitamin D treatment, appears not only to be feasible, tolerable and safe, but also appears to create a strong immune response and could preserve the body’s own insulin-producing ability. We now intend to expand the study to include additional patients. It is very exciting.”
DIAGNODE-1 is an open pilot study comprising a total of five patients between the ages of 18 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 this study, Diamy is combined with orally administered vitamin D. A study-expansion application has been submitted to the Swedish Medical Products Agency.