Diamyd Medical will test a new way to give Diamyd in a clinical study with five adults newly diagnosed with type 1 diabetes.
Diamyd will in this study be administered directly into lymph nodes in combination with treatment with vitamin D, announces the company. The investigator initiated study has been approved by the Swedish MPA.
“This is an innovative approach that may become important both for the treatment of type 1 diabetes as well as other autoimmune diseases,” says Professor Johnny Ludvigsson at Linköping University, principal investigator of the study. “We have previously shown that Diamyd has some effect in terms of preservation of the insulin producing beta cells and now we are trying different ways to enhance this effect. Direct intralymphatic administration is one such way. Combination regimens with potentially effective molecules that fight the disease from other angles is another way. Just as in cancer therapy, different combination regimens must be tested to arrive at a cure of autoimmune diabetes.”
The new study, DIAGNODE, is an open label pilot study with five patients between 18 and 30 years of age who have been diagnosed with type 1 diabetes within 6 months. An initial evaluation will be made after 6 months, with a focus on safety and immunological markers, and the patients will thereafter be followed for another 24 months. All five participants will receive a low dose (4μg) of Diamyd in the lymph node on three occasions. Diamyd is in this study combined with a high dose of vitamin D. The vitamin D is provided in order to down regulate the immune system’s inflammatory components to thereby increase the ABT’s tolerance inducing effect in regard of preserving the patient’s insulin producing capacity.