Swedish clinical-stage diabetes company Diamyd Medical AB (Nasdaq First North Growth Market:DMYD-B) announced on Thursday a new investigator-initiated clinical trial to evaluate an additional injection (booster) with antigen-specific immunotherapy Diamyd.
The trial, DIAGNODE-B, is planned to start this spring.
The Swedish Medical Products Agency and the Ethical Review Authority have approved the trial, which will be offered to approximately six Type 1 diabetes patients from the previous trials DIAGNODE-1 and DIAGNODE-2.
Participants will have previously been treated with either three or four intralymphatic injections of Diamyd. All patients carry the genetically defined HLA DR3-DQ2 haplotype, which has shown to be linked to significant and clinically relevant treatment efficacy with Diamyd, the company said.
The aim of the new trial is to evaluate the safety of a booster (fourth/fifth) injection with Diamyd and the effect on the immune system and endogenous insulin production. The patients will be followed for 12 months after injection.
Diamyd Medical granted US FDA Fast Track designation for Diamyd diabetes treatment
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