Policy & Regulation
Diamyd Medical pauses start of diabetes vaccine trial
30 November 2021 -

Diamyd Medical AB (Nasdaq First North Growth:DMYDB) said on Tuesday that it is postponing the start of the precision medicine Phase III trial DIAGNODE-3 as well as the initiation of other clinical trials with the diabetes vaccine Diamyd (GAD/alum) pending additional evaluations of the manufacturing process.

This decision was made after a new analysis showed the potential presence of a contamination early in the manufacturing process of the study drug.

Diamyd Medical will evaluate its specific removal before additional clinical work is conducted, the company said.

"We take this new information seriously and deem it is most prudent to pause the initiation of pending clinical trials in order to thoroughly assess the situation," commented Ulf Hannelius, CEO of Diamyd Medical. "While our insights regarding precision medicine, safety and efficacy have elevated the diabetes vaccine, recent events show that we have challenges with manufacturing."

Hannelius added: "For the time being we will focus all our resources on strengthening the manufacturing platform to make sure the diabetes vaccine Diamyd can reach its full potential."

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