Study where Diamyd® is administered directly into lymph nodes approved for expansion and inclusion of children from 12 years of age

Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced
that DIAGNODE-1, an open-label clinical pilot study in which the diabetes
vaccine Diamyd® is administered directly into lymph nodes, has been approved by
the Swedish Medical Products Agency and the Ethics Review Board to be expanded
from five to nine patients and to include children from 12 years of age.
As previously communicated, Professor Johnny Ludvigsson, principal investigator
and sponsor of DIAGNODE-1, has submitted a first preliminary evaluation of data
from the first four patients that have been monitored for six months in the
study, as an abstract for the diabetes meeting “51st Annual Meeting of the
Scandinavian Society for the Study of Diabetes (SSSD)” to be held in Reykjavik,
Iceland, on April 21-22, 2016. This evaluation preliminarily shows that the
treatment appears to be safe and tolerable. Even if the clinical progression in
patients shows certain positive data in terms of the body’s own capacity to
produce insulin, as well as better long-term blood sugar and lower insulin dose
(please see press release issued on February 11, 2016), no conclusions are drawn
regarding metabolic parameters in these few patients who still may be in the so
called honeymoon-phase, often characterized by some regression of the disease.

This data has served as the basis for an application to expand the study from
five to nine participants and also to include children and adolescents from 12
years of age. This application has now been approved by the Swedish Medical
Products Agency and the Ethics Review Board.

“This is a step forward for this new innovative treatment concept; to be able to
study more but also younger patients where the value of immune intervention to
save residual insulin secretion is deemed the most important,” says Professor
Johnny Ludvigsson at Linköping University, principal investigator and sponsor of
the study.

The pilot study DIAGNODE-1 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,
while concurrently decreasing the dose. 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 with the aim of preserving the
patient’s insulin producing capacity.

DIAGNODE-1 is an open pilot study which after this approval comprises a total of
nine patients between the ages of 12 and 30 who have been diagnosed with type 1
diabetes in the past six months. The patients are monitored for 30 months. All
participants are given a low dose (4µg) of Diamyd® into a lymph node on three
occasions, in combination with intake of vitamin D.

About Diamyd® and combination trials

Type 1 diabetes is a devastating disease which requires daily treatment with
insulin to sustain life. The importance of finding a cure should not be
underestimated. The diabetes vaccine Diamyd® has been used in clinical studies
with more than 1,000 patients and has shown a good safety profile. In a European
Phase III trial Diamyd® showed good clinical effect in several subgroups, and a
limited overall 16% efficacy (p=0.10) in preserving endogenous insulin
secretion. Subsequent development is focused on combination trials to enhance
efficacy. Diamyd® is easy to administer in any clinical setting. The potential
annual market is estimated to several billion dollars per year.

Six researcher initiated clinical trials are ongoing combining Diamyd® with
various other immunomodulatory compounds; etanercept, ibuprofen, vitamin D and
GABA.

  · DIABGAD-1 – COMBINING DIAMYD® WITH IBUPROFEN AND VITAMIN D

A placebo-controlled trial, where Diamyd® is being tested in combination with
ibuprofen and vitamin D. The trial 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 own capacity to produce insulin. The trial runs at nine clinics in
Sweden and is led by Professor Johnny Ludvigsson at Linköping University,
Sweden. 30 month results from the trial are due during the first half year of
2017.

  · DIAGNODE-1 –DIAMYD® IN LYMPH GLANDS IN COMBINATION WITH VITAMIN D

An open label trial, where Diamyd® is administered directly into lymph nodes in
combination with treatment with vitamin D. The trial comprises nine patients
between the ages of 12 and 30 newly diagnosed with type 1 diabetes, and will
continue for a total of 30 months. The aim of the trial is to evaluate the
safety of the combination treatment and the effect on the immune system and the
patients’ insulin producing capacity. The trial is led by Professor Johnny
Ludvigsson at Linköping University, Sweden. The first patient was included in
the trial in February 2015.

  · GABA/DIAMYD® – COMBINING DIAMYD® WITH GABA

A placebo-controlled trial, where Diamyd® is being tested in combination with
GABA. The trial comprises 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 trial is led by Professor Kenneth McCormick at the
University of Alabama at Birmingham, USA. The first patient was included in the
trial in March 2015.

  · EDCR IIa – COMBINING DIAMYD® WITH ETANERCEPT AND VITAMIN D

An open label trial, where Diamyd® is combined with etanercept and vitamin D.
The trial comprises 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 trial is to evaluate the safety of the combination treatment and the
effect on the immune system and the patients’ insulin producing capacity. The
trial is led by Professor Johnny Ludvigsson at Linköping University, Sweden. The
first patient was included in May 2015.

  · DiAPREV-IT 1– DIAMYD®

A placebo-controlled trial, where Diamyd® is being tested in children at high
risk of developing 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 trial, which will last for five years. The aim of the trial is to evaluate
whether Diamyd® can delay or prevent the participants from presenting with type
1 diabetes. The trial is led by Dr. Helena Elding Larsson at Lund University,
Sweden. Five year results are expected at the end of 2016.

  · DiAPREV-IT 2 – COMBINING DIAMYD® WITH VITAMIN D

A placebo-controlled trial, where Diamyd® is being tested in combination with
vitamin D in children at high risk of developing 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 trial, which will last for five years. The
aim of the trial is to evaluate whether Diamyd® can delay or prevent the
participants from presenting with type 1 diabetes. The trial is led by Dr.
Helena Elding Larsson at Lund University, Sweden. The first patient was included
in March 2015.

About Diamyd Medical
Diamyd Medical is dedicated to finding a cure for autoimmune diabetes through
pharmaceutical development and investments in stem cell and medical technology.

Diamyd Medical develops the diabetes vaccine Diamyd®, an Antigen Based Therapy
(ABT) based on the exclusively licensed GAD-molecule. The Company’s licensed
technologies for GABA and Gliadin have also potential to become key pieces of
the puzzle of a future solution to prevent, treat or cure autoimmune diabetes,
and also certain inflammatory diseases. At this time six clinical studies are
ongoing with Diamyd®. Diamyd Medical is with its holdings of 45% one of the
major shareholders in the stem cell company Cellaviva AB. Stem cells can be
expected to be used in Personalized Regenerative Medicine (PRM), for example for
restoration of beta cell mass in diabetes patients where the autoimmune
component of the disease has been arrested. Diamyd Medical also has holdings in
the medtech company Companion Medical, Inc., San Diego, USA and in the gene
therapy company Periphagen, Inc., Pittsburgh, USA.

Diamyd Medical’s B-share is traded on Nasdaq Stockholm First North under the
ticker DMYD B. Remium Nordic AB is the Company’s Certified Adviser.
For further information, please contact:
Anders Essen-Möller, President and CEO
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.