Diamyd performs immunological marker evaluation of diabetes vaccine
DIABGAD is just one of the company’s five ongoing clinical studies seeking a vaccine for diabetes. The vaccine combines ibuprofen, vitamin D and a combination of single or double doses of vitamin D. The evaluation results show that the Diamyd treatment has affected both inflammatory as well as anti-inflammatory immunological markers and reveals positive feedback about the treatment’s safety.
“Thus far we can see that vitamin D concentrations in serum are elevated, GAD antibodies are induced as expected, and that the treatment has GAD-specific effects both with regards to anti-inflammatory and inflammatory cytokine responses,” principal investigator Johnny Ludvigsson of Linköping, Sweden, said. “It will be exciting to see how this can affect parameters such as endogenous insulin producing capacity at 15 months.”
The company plans to release information about the metabolic results of the study and the vaccine by the end of 2015, at which time all of the patient subjects will have finished their follow-up after 15 months of treatment. Metabolic rates are important for a diabetes patient, as these rates impact the body’s ability to secrete insulin.
“These immunological results, six months into the study, should be seen as partial results of the complete study DIABGAD,” Diamyd Medical CEO and President Anders Essen-Möller said. “We can also use them to compare the immunological influence of different treatment concepts in other studies with Diamyd. To attack the disease process from several angles simultaneously by combining Diamyd with other drugs, or by administering Diamyd directly into lymph nodes or earlier in the disease process, are alternative approaches tested in five different clinical studies today. From a safety perspective we consider the six-month results good. Even if we cannot draw any conclusion from these immunological results with regards to a clinically relevant effect on metabolic diabetes associated parameters, we have good hope, as previously informed, that the 15-month results by the end of this year will show positive metabolic results.”