First patient enrolled in new study where the Diamyd® diabetes vaccine is administered directly into lymph nodes - DIAGNODE has started

Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) informs that the
first patient has been enrolled in the DIAGNODE study. In the study a new way to
administer the Diamyd® diabetes vaccine is tested, directly into inguinal lymph
nodes.
DIAGNODE is the first study of its kind, where a low dose of Diamyd® is
administered directly into lymph nodes in combination with treatment with
vitamin D. The concept, for which Diamyd Medical has submitted a patent
application, can be compared to the development in allergy therapy, where the
administration of allergen into lymph nodes has significantly improved efficacy.
It is an interesting approach that is now being tried at Linköping University in
a small group of adult subjects recently diagnosed with type 1-diabetes.

DIAGNODE is an open label pilot study with five patients between 18 and 30 years
of age who have been diagnosed with type 1 diabetes within 6 months. An initial
evaluation will be made after 6 months, with a focus on safety and immunological
markers, and the patients will thereafter be followed for another 24 months.

All five participants will receive a low dose (4μg) of Diamyd® in the lymph node
on three occasions. Diamyd® is in this study combined with a high dose of
vitamin D. The vitamin D is provided in order to down regulate the immune
system’s inflammatory components to thereby increase the diabetes vaccine’s
tolerance inducing effect in regard of preserving the patient's insulin
producing capacity.

”This is a unique study where we hope that the effect of the diabetes vaccine
will be enhanced,” says Professor Johnny Ludvigsson, Linköping University,
Sweden, who is the Principal Investigator of the study. “Giving the diabetes
vaccine directly into lymph nodes is an innovative approach that may become of
importance both in the treatment of type 1 diabetes as well as other autoimmune
diseases.”

About the Diamyd® diabetes vaccine
Diamyd® is the world’s furthest developed Antigen Based Therapy for preventing,
delaying or stopping the autoimmune attack on beta cells in type 1 diabetes and
other forms of autoimmune diabetes and thus preserving the body’s own ability to
produce insulin. The diabetes vaccine Diamyd® is easily administered in any
clinical setting and has been used in studies with more than 1000 diabetes
patients. In a European Phase III study with children and adolescents recently
diagnosed with type 1 diabetes, Diamyd® showed an overall 16% efficacy (p=0.10)
versus placebo in preserving endogenous insulin secretion. Ongoing development
work is aimed at enhancing the efficacy of the treatment by combining Diamyd®
with other agents. Three clinical studies with Diamyd® are ongoing and an
additional three are being launched.

  · DIABGAD-1. A placebo-controlled study, where Diamyd® is being tested in
combination with ibuprofen and vitamin D. The study comprises a total of 64
patients between the ages of 10 and 18 recently diagnosed with type 1 diabetes,
and will continue for a total of 30 months. The aim of the combination treatment
is to preserve the body’s residual capacity to produce insulin. All of the
participants have been enrolled in the study and the initial six-month results,
focusing on immunological markers, are expected to be presented in the spring of
2015. The study runs at nine clinics in Sweden and is led by Professor Johnny
Ludvigsson at Linköping University.

  · DIAPREV-IT. A placebo-controlled study, where Diamyd® is being tested in
children with early stages of type 1 diabetes, meaning that they have been found
to have an ongoing autoimmune process but do not yet have any clinical symptoms
of diabetes. A total of 50 participants from the age of four have been enrolled
in the study, which will last for five years. The aim of the study is to
evaluate whether Diamyd® can delay or prevent the participants from presenting
with type 1 diabetes. The study is taking place in Sweden led by Dr. Helena
Elding Larsson at Lund University. Results are expected at the end of 2016.

  · DIAGNODE. An open label study, where Diamyd® is administered directly into
lymph nodes in combination with treatment with vitamin D. The study will
comprise five patients between the ages of 18 and 30 who have been newly
diagnosed with type 1 diabetes, and will continue for a total of 30 months. The
aim of the study is to evaluate the safety of the combination treatment and the
effect on the immune system and the patients’ insulin producing capacity. The
study is taking place in Sweden led by Professor Johnny Ludvigsson and enrolled
the first patient in February 2015.

  · DIAMYD®/GABA. A placebo-controlled study, where Diamyd® is being tested in
combination with GABA. The study will comprise 75 patients between the ages of 4
and 18 recently diagnosed with type 1 diabetes, and will continue for a total of
12 months. The aim of the combination treatment is to preserve the body’s
residual capacity to produce insulin. The study is taking place in the US led by
Professor Kenneth McCormick at the University of Alabama at Birmingham and is in
the start-up phase.

  · DIAPREV-IT 2. A placebo-controlled study, where Diamyd® is being tested in
combination with vitamin D in children with early stages type 1 diabetes,
meaning that they have been found to have an ongoing autoimmune process but do
not yet have any clinical symptoms of diabetes. A total of 80 participants
between the ages of 4 and 18 will be enrolled in the study, which will last for
five years. The aim of the study is to evaluate whether Diamyd® can delay or
prevent the participants from presenting with type 1 diabetes. The study is
taking place in Sweden led by Dr. Helena Elding Larsson and is in the start-up
phase.

  · EDCR IIa. An open label study, where Diamyd® is combined with etanercept and
vitamin D. The study will comprise 20 patients between the ages of 8 and 18 who
have been newly diagnosed with type 1 diabetes, and will continue for a total of
30 months. The aim of the study is to evaluate the safety of the combination
treatment and the effect on the immune system and the patients’ insulin
producing capacity. The study is taking place in Sweden led by Professor Johnny
Ludvigsson and is in the start-up phase.

About Diamyd Medical
Diamyd Medical is dedicated to fighting type 1 diabetes and to working toward a
cure for the disease. Its projects include development of combination regimens
with the GAD-based Diamyd® diabetes vaccine for arresting the successive
destruction of insulin-producing beta cells. Diamyd Medical has an exclusive
license to patent rights held by the UCLA related to the GAD molecule. The
company has also an exclusive license from UCLA for GABA for the treatment of
diabetes and other inflammation-related conditions.

Diamyd Medical is a shareholder in the stem cell company Cellaviva AB, which is
establishing a Swedish commercial bank for private family saving of stem cells
in umbilical cord blood and other sources of stem cells. Stem cells are expected
to be used in Personalized Regenerative Medicine (PRM), for example, to restore
beta cell mass in diabetes patients where autoimmunity has been arrested. Diamyd
Medical also has an ownership stake in the US medical technology company
Companion Medical, Inc., and a minor shareholding and other financial interests
in the US gene therapy company Periphagen Holdings, Inc.

Remium Nordic AB is the Company’s Certified Adviser.
For further information, please contact:
Anders Essen-Möller, Chairman, Phone: +46 70 55 10 679. E-mail: anders.essen
-moller@diamyd.com
Diamyd Medical AB (publ), Kungsgatan 29, SE-111 56 Stockholm, Sweden. Phone: +46
8 661 00 26,
Fax: +46 8 661 63 68. E-mail: info@diamyd.com. Reg. no.: 556242-3797. Website:
www.diamyd.com.