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// COLLABORATIONS R&D Diamyd Medical receives FDA Fast Track designation Matti Sällberg, Dean of Karolinska Institutet's Southern Campus The U.S. Food and Drug Administration has granted the designation for Diamyd that is being investigated to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2. SWEDEN DEVASTATING FREEZER FAILURE AT KAROLINSKA INSTITUTET During the Christmas holidays, the automatic filling of the cryotanks with liquid nitrogen was interrupted for an unknown reason in the Neo building on the institute’s Flemingsberg campus. AS A RESULT of the failure, the temperature in 16 of 19 cryogenic tanks rose and large amounts of biological research material dating back decades have been destroyed, reports Karolinska Institutet (KI). The automatic refilling of nitrogen ensures that the correct temperature of -190 °C can be maintained in the tanks but, for reasons unknown, the flow of nitrogen from the external storage tank malfunctioned, and the temperature in 16 of the tanks rose. The Neo’s cryo tanks contain biomaterial and cell lines from multiple departments. The Department of Medicine, Huddinge (MedH), was most affected, and in particular research areas of hematology, endocrinology and cardiology. The samples were all strictly for research so it would not affect the care of any current patients, but had been intended to be used in future research. “Those worst affected are those researching leukemia, they have gathered samples from patients over as much as 30 years,” said Matti Sällberg, Dean of KI's southern campus, to APF. He said no official estimate of the value of the samples lost had been made, but said it was easily in the millions. “The analyses made so far speak for themselves: the malfunction will have far-reaching consequences for the department's research in the affected areas,” stated Professor Petter Höglund, head of MedH, to KI. An internal investigation has been launched at the university and despite there being no indication of sabotage, the incident has also been reported to police. NLS "WE ARE VERY pleased with the FDA’s decision and the potential this provides to accelerate Diamyd’s path to entering the US market,” says Ulf Hannelius, CEO, Diamyd Medical. “Diamyd, currently evaluated in the first ever precision medicine Phase 3 trial in Type 1 diabetes, DIAGNODE-3, represents a significant shift towards personalized medicine in the treatment of type 1 diabetes. This offers new hope beyond the traditional insulin therapy, emphasizing our dedication to advancing care and improving outcomes for patients.” DIAGNODE-3 is ongoing in the United States and in eight European countries: Sweden, Spain, the Czech Republic, the Netherlands, Germany, Poland, Hungary and Estonia. The trial will enroll up to 330 individuals aged 12 to 29 years, recently diagnosed (within six months) with Type 1 Diabetes, who carry the HLA DR3-DQ2 haplotype, a certain genetic risk factor for Type 1 Diabetes. A further stratification for HLA haplotypes is included in order to evaluate the potential super responder group of individuals who are positive for HLA DR3DQ2 and negative for HLA DR4-DQ8. NLS 18 | NORDICLIFESCIENCE.ORG PHOTO ERIK FLYG