Diamyd Medical announces that its lead drug candidate, Diamyd(TM), has demonstrated overall statistically significant efficacy in preserving insulin production in a Phase II clinical trial in 70 children and adolescents with Type 1 diabetes. No serious adverse events associated with the therapy were observed. The Principal Investigator found that the treatment is easy to give and that the study outcomes are of clinical importance for the treatment of Type 1 diabetes.
The results from the Diamyd(TM) study demonstrate that the group of 35 recently diagnosed Type 1 diabetes patients that received Diamyd(TM) produced approximately twice as much meal stimulated insulin (as measured by C-peptide) 15 months after the first treatment as compared to the placebo group (p ~ 0.01).
The ability of the beta cells to produce insulin in response to a meal is considered to be the key factor when it comes to assessing beta cell function. As insulin and C-peptide are produced in equal amounts and C-peptide is easier to measure, meal stimulated C-peptide levels are the most important parameter to follow in a Type 1 diabetes study where the aim is to preserve beta cell function. The C-peptide production in both groups experienced a decline but the decline was significantly inhibited in the Diamyd(TM) group. There were no significant differences in fasting C-peptide levels between the two groups. The treatment itself consisted of two injections of 20 mg Diamyd(TM), one at day one and one at day 30.
"This is a breakthrough," states Johnny Ludvigsson, M.D., Professor of Pediatrics at the University Hospital, Linkoping University, Sweden and the Principle Investigator on the study that was carried out at 8 hospitals in Sweden. "This clearly offers the potential to improve treatment of Type 1 diabetes. Endogenous insulin production is very important as it helps patients to better control their disease and reduce complications. The demonstrated effect is of clinical importance. The treatment is very easy to give, only two injections in total and it was very well received by patients, parents and doctors. In this trial, safety was not an issue."
"That Diamyd(TM) demonstrated the ability to preserve the function of pancreatic beta cells in Type 1 diabetes patients is a very encouraging trial result," stated Professor Mark Atkinson, Sebastian Family Eminent Scholar for Diabetes Research at the University of Florida, from which Diamyd Medical has licensed the rights to use GAD65 for treatment of diabetes.
Diamyd Medical’s research program was preceded by studies from the early 1980s where Professors Johnny Ludvigsson, Ake Lernmark, and Steinun Baekkskov discovered the autoantigen that later proved to be GAD65, the active ingredient in the Diamyd(TM) therapeutic. The GAD genes were subsequently isolated by Dr. Allan Tobin’s laboratory at UCLA. In 1996, Drs. Daniel Kaufman and Jide Tian (UCLA) demonstrated that GAD-specific autoantigen therapy could effectively prevent Type 1 diabetes-prone mice, providing a proof of principle for subsequent clinical trials.
A scientific and in depth presentation of the study results will be presented on September 17, by Professor Johnny Ludvigsson at the European Diabetes Congress, EASD, in Copenhagen.
Diamyd Medical News Release
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