Immunological markers affected after six months in a first combination study with the diabetes vaccine Diamyd®

Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) announced today
that a first evaluation, after six months, of immunological markers in DIABGAD
has been performed. DIABGAD is one of five ongoing clinical studies with the
diabetes vaccine Diamyd®. Both anti-inflammatory and inflammatory immunological
markers are affected by the Diamyd® treatment. The safety profile is good, with
regards to the combination of Diamyd® with vitamin D and ibuprofen, as well as
the combination of single or double doses of Diamyd® with vitamin D. Metabolic
results, such as the treatment’s effect on the ability to produce insulin, are
expected to be ready for presentation by end of 2015 when all patients have
completed their 15-month follow-up.
The immunological results after six months are presented at an international
diabetes congress, IDS, held in Munich on April 12-16, 2015.

“This far we can see that vitamin D concentrations in serum are elevated, GAD
antibodies are induced as expected, and that the treatment has GAD-specific
effects both with regards to anti-inflammatory and inflammatory cytokine
responses,” says Professor Johnny Ludvigsson, Linköping, Sweden, principal
investigator and sponsor of the study. “It will be exciting to see how this can
affect parameters such as endogenous insulin producing capacity at 15 months.”

The study DIABGAD, which is the first study of its kind, combines the diabetes
vaccine Diamyd® with relatively high daily doses of vitamin D and the anti
-inflammatory drug ibuprofen. The aim with the combination treatment is, after
15 months, to see a difference between treated patients and placebo with regards
to the body’s own ability to produce insulin in children and adolescents, newly
diagnosed with type 1 diabetes. The patients will be followed for a total period
of 30 months.

“These immunological results, six months into the study, should be seen as
partial results of the complete study DIABGAD,” says Anders Essen-Möller,
President and CEO of Diamyd Medical. “We can also use them to compare the
immunological influence of different treatment concepts in other studies with
Diamyd®. To attack the disease process from several angles simultaneously by
combining Diamyd® with other drugs, or by administering Diamyd® directly into
lymph nodes or earlier in the disease process, are alternative approaches tested
in five different clinical studies today. From a safety perspective we consider
the six-month results good. Even if we cannot draw any conclusion from these
immunological results with regards to a clinically relevant effect on metabolic
diabetes associated parameters, we have good hope, as previously informed, that
the 15-month results by the end of this year will show positive metabolic
results.”

DIABGAD is a double-blind, randomized and placebo-controlled Phase II study in
which 64 children and adolescents, 10-18 years of age and newly diagnosed with
type 1 diabetes, have been treated with either the diabetes vaccine Diamyd® or
placebo in combination with ibuprofen and vitamin D. The patients are randomly
assigned to four treatment groups: a) Diamyd® in combination with ibuprofen and
vitamin D, b) Diamyd® in combination with vitamin D, c) Diamyd® in double dose
in combination with vitamin D; d) Placebo (inactive substance).

About the diabetes vaccine Diamyd®
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. Diamyd® is considered to be the world’s furthest developed
Antigen Based Therapy (ABT) for treating the disease. 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 study Diamyd® showed good clinical effect in
several subgroups, and a limited overall 16% efficacy (p=0.10) in preserving
endogenous insulin secretion. To enhance the overall effect, combination
treatments with Diamyd® and other approved agents are being pursued. Diamyd® is
easy to administer in any clinical setting. The potential annual market is
estimated to several billion dollars.

Five researcher-initiated clinical studies with Diamyd® are ongoing and one
additional is 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 presented in April 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 very 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 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. The
first patient was included in March 2015.

  · DiAPREV-IT 2. A placebo-controlled study, where Diamyd® is being tested in
combination with vitamin D in children with very 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 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. The first
patient was included in March 2015.

  · 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 working toward a cure for type 1 diabetes and
LADA. The Company’s projects include development of combination regimens with
the GAD-based diabetes vaccine Diamyd® for arresting the destruction of insulin
-producing beta cells. The Company exclusively licenses UCLA-rights to GAD65,
the active ingredient in the vaccine, for which the last patent expires in 2032.
Additionally, the Company exclusively licenses UCLA patents for using GABA for
the treatment of diabetes and other inflammation-related conditions.

Diamyd Medical is one of the major shareholders 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 can be expected to be used in Personalized Regenerative Medicine
(PRM), for example, to restore beta cell mass in diabetes patients where
autoimmunity has been arrested.

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.