Last patient completes the EU Phase III study of Diamyd® antigen based therapy for type 1 diabetes

Last patient completes the EU Phase III study of Diamyd® antigen based
therapy for type 1 diabetes

The final patient has performed the last visit of the main study period
in Diamyd Medical's European Phase III study. Treatment with the antigen
based therapy Diamyd® is made to investigate whether beta cell function
and thereby blood sugar control can be preserved in children and
adolescents with new onset type 1 diabetes. The top line results from
this study are expected to be reported as planned, in late spring 2011.

The last patient in the EU Diamyd Phase III clinical study has completed
the 15-month visit, meaning that all patients in this study have
completed the main 15 month study period in this trial. This important
achievement in the Diamyd® Phase III program will now be followed by an
intense period where the data will be compiled from the more than 60
clinics throughout Europe and from the central laboratory. The extensive
work of data compilation and processing will continue for the next
months, after which the study will be unblinded. The top line results
are expected to be reported as planned, in late spring 2011. With good
results, Diamyd intends to apply for market approval by the end of this
year.

"This is an extremely important period not only for Diamyd Medical, but
also for the physicians who perform this study as well as for all the
children, adolescents and parents who have chosen to participate in the
study. The results are also of tremendous importance for the entire
field of diabetes research,” says Elisabeth Lindner, CEO and President
of Diamyd Medical.

The first patient in the Diamyd EU Phase III study was enrolled in the
autumn of 2008, and the trial was fully recruited in November 2009. All
patients have now been followed for 15 months, which is the main study
period for this trial. As part of a planned, longer term follow on
study, the patients will be followed for an additional 15 months, to
further evaluate the safety and efficacy of the antigen based therapy
Diamyd®.

The EU Phase III study is a multinational, multicenter, double-blind,
randomized, placebo-controlled trial enrolling approximately 320
patients between 10 and 20 years of age who have been diagnosed with
type 1 diabetes within three months. The study is being conducted at
more than 60 clinics in nine European countries, i.e. Finland, France,
Germany, Holland, Italy, Slovenia, Spain, Sweden and UK. One third of
the patients received four injections with Diamyd®, one third received
two injections with Diamyd® followed by two injections with placebo, and
one third has received four injections with placebo. The injections were
given on Day one, and then after one month, three months and nine
months.

In its global Phase III program, Diamyd is also conducting a similar
study in the U.S., DiaPrevent, which was fully enrolled in December
2010. Diamyd expects to complete the main study period of this study
during the spring of 2012.

The global Phase III program aims to investigate whether Diamyd® can
halt or slow the destruction of beta cells in the pancreas in type 1
diabetes, preserving the beta cell function and the body's own ability
to control the blood sugar level. This in turn reduces the risk of both
short and long term diabetes complications. In Phase II studies, the
Diamyd® therapy has been shown to slow the loss of beta cell function
compared to placebo.

The two studies have now enrolled more than 640 recently diagnosed type
1 diabetes patients between 10 and 20 years of age in Europe and USA.

For more information, please contact:
Elisabeth Lindner, President and CEO Diamyd Medical AB (publ.)
Phone: +46 8 661 0026

For pictures and press material, please contact:
Andreas Ericsson, Diamyd Medical AB (publ.)
andreas.ericsson@diamyd.com
Phone: +46 8 661 0026