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Diamyd Medical contracts global CRO for Phase III trial with the diabetes vaccine Diamyd®

Diamyd Medical contracts global CRO for Phase III trial with the diabetes vaccine Diamyd®
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Diamyd Medical contracts global CRO for Phase III trial with the diabetes vaccine Diamyd

Diamyd Medical contracts global CRO for Phase III trial with the diabetes vaccine Diamyd STOCKHOLM, April 15, 2021 /PRNewswire/ Diamyd Medical has contracted the global contract research organization (CRO) ICON plc for DIAGNODE-3, a placebo-controlled Phase III precision medicine trial with the diabetes vaccine Diamyd . The trial is designed to confirm the efficacy and safety of Diamyd in individuals recently diagnosed with type 1 diabetes who carry the genetically defined haplotype HLA DR3-DQ2. The trial is expected to begin recruiting patients later this year. We have gotten to know ICON as a very skilled and committed collaboration partner during the preparation of our Phase III trial, says Ulf Hannelius, CEO of Diamyd Medical. Now we take the next critical step together with a focus on precision medicine for type 1 diabetes, and with over SEK 200 million in cash, we can move full speed ahead with getting the trial started in all countries and clinics.

Diamyd Medical Selects Cytiva s FlexFactory Platform

Diamyd Medical Selects Cytiva s FlexFactory Platform
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Update on the design of a Phase III Precision Medicine trial with the Diabetes Vaccine Diamyd

Update on the design of a Phase III Precision Medicine trial with the Diabetes Vaccine Diamyd The upcoming Phase III trial with Diamyd in new-onset type 1 diabetes will be based on the first precision medicine approach in the field. The trial is designed to confirm the effect and safety of Diamyd in individuals recently diagnosed with type 1 diabetes who carry the genetic HLA DR3-DQ2 haplotype. The Phase III trial is designed to enroll approximately 330 individuals aged 12 to 28, recently diagnosed with type 1 diabetes, who carry the HLA DR3-DQ2 haplotype. This patient population is based on clinical efficacy and safety results from the Phase IIa and Phase IIb trials DIAGNODE-1 and DIAGNODE-2, as well as the large-scale meta-analysis encompassing data from more than 600 individuals from previous Phase II and Phase III trials using Diamyd

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