Investigational type 1 diabetes drug reaches Phase III trial
The selective chemokine interleukin-8 inhibitor has been advanced into a Phase III trial after previous studies showed it can improve the efficacy and safety of transplantation of pancreatic islet cells in type 1 diabetics .
Described by Dompe as "the new frontier in type 1 diabetes", islet transplantation is an experimental procedure that involves taking isolated islet cells - clusters of cells in the pancreas that include insulin-producing beta cells - from a donor pancreas and transferring them into another person to enable the production and release of insulin, which is required for regulating blood glucose levels.
"The idea that a targeted anti-inflammatory treatment could help pancreatic islet transplantation become a standard procedure has been confirmed in earlier clinical trials on this investigational drug," said principal investigator, Lorenzo Piemonti of the San Raffaele Hospital in Milan.
"Our hope and goal is to see significant improvement of patient's quality of life and lower immune suppression-related risk."
The Phase III trial will involve a total of 60 patients and will be conducted in 10 centres across Europe and America.
Dompe chief executive, Eugenio Aringhieri, said the beginning of the late-stage study "marks a key milestone" for the Milan-based firm, adding that global cases of type 1 diabetes are on the rise, causing a significant impact on "the young population".
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