Prevention study with Diamyd´s diabetes vaccine fully recruited
A total of 50 children aged four and older with a high risk of developing type 1
diabetes have been enrolled in a researcher-initiated Phase II study,
DiAPREV-IT, with Diamyd Medical’s diabetes vaccine Diamyd®. The study is thus
fully recruited. The purpose of the study is to evaluate whether preventive
treatment with Diamyd® can delay or halt the progression of the disease so that
the children do not develop clinical symptoms of type 1 diabetes.
The children enrolled in the study are healthy, but have all been found to have
an ongoing autoimmune process, where their blood sugar-regulating beta cells in
the pancreas are being destroyed by their own immune system. If the destruction
is not stopped, it can with time lead to type 1 diabetes. Preventive treatment
with Diamyd® is intended to intervene in the autoimmune process at an early
stage, and thus prevent the disease from developing. Today there is no treatment
that can halt the progress of disease in type 1 diabetes.
“It is very exciting to follow the children in this prevention study, which is
the first of its kind,” says Peter Zerhouni, President and CEO of Diamyd
Medical. “This study provides valuable information that can form the basis for
larger prevention studies. If it turns out that preventive treatment with our
diabetes vaccine reduces the risk of developing type 1 diabetes in these
children it would be a great step forward in diabetes research.”
The study is being conducted by a research group at Lund University and is led
by Dr. Helena Elding Larsson, a pediatrician in Malmö and researcher at Lund
University. The study is funded by research grants, but Diamyd Medical has
participated in the design of the study and can utilize the study results.
“I think there is a good chance that the diabetes vaccine can have effect in the
preventive treatment of children who have not yet been diagnosed with type 1
diabetes,” says Helena Elding Larsson. “In DiAPREV-IT, we vaccinate the children
early in the disease process when they still have many beta cells left to save
and the disease process is not as aggressive as in newly diagnosed, which should
increase the chance that the vaccine will have an effect.”
DiAPREV-IT, which was started in 2009, is a double-blind, placebo-controlled
Phase II study including a total of 50 children aged four and older who through
analysis of diabetes markers, so-called auto-antibodies, in the blood are
demonstrated to be at high risk of developing type 1 diabetes. Study
participants have auto-antibodies against GAD65 and at least one other
auto-antibody. Half of the children receive two injections of Diamyd®, and the
remaining half receive placebo (inactive substance). The children will be
monitored for a total of five years by means of sampling and glucose tolerance
tests to evaluate the beta cell function, a measure of the body's own ability to
regulate blood sugar. The first results are expected to be compiled three years
after the last participant is enrolled, and can thereby be presented in 2015.
Diamyd® has previously been evaluated in a Phase III study of children already
diagnosed with type 1 diabetes. The Phase III study did not met the primary
efficacy endpoint of preserving beta cell function. Safety data from the study
showed that Diamyd® was well tolerated, as demonstrated by a similar number of
adverse events reported across all treatment groups.
For more information, please contact:
Peter Zerhouni, President and CEO Diamyd Medical AB
Phone: 46 8 661 00 26
For press material, please contact:
Andreas Ericsson, Diamyd Medical AB
press@diamyd.com
Phone: 46 8 661 00 26
