EDCR has started – first patient included in new study combining the diabetes vaccine Diamyd® with etanercept

Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) announced today
that the first patient has been included in a new study, EDCR, in which the
diabetes vaccine Diamyd® will be combined with two other approved agents, the
immunosuppressive drug etanercept and vitamin D, with the aim to evaluate the
safety of the combination treatment as well as its impact on the immune system
in children and adolescents newly diagnosed with type 1 diabetes. With the start
of EDCR a total of six clinical studies are now ongoing where alternative
approaches with Diamyd® are being tested, either in combination with other
agents or by administering the diabetes vaccine at an earlier stage in the
disease process, prior to type 1 diabetes diagnosis.
The first patient has now been included in the study EDCR (Etanercept-Diamyd®
-Combination-Regimen) which will include 20 children and adolescents between 8
to 18 years of age, newly diagnosed with type 1 diabetes. The aim of the study
is to evaluate the combination treatment of Diamyd®, etanercept and vitamin D,
from a safety and immunological perspective. Etanercept is a so called TNF-alpha
inhibitor used in rheumatic diseases, for example for treating children with
juvenile idiopathic arthritis.

“It is an exciting concept to use etanercept to suppress harmful parts of the
immune system that are activated in new onset type 1 diabetes and
simultaneously, in a discrete antigen-specific fashion, try to induce tolerance
with the diabetes vaccine Diamyd®”, says Professor Johnny Ludvigsson, Linköping,
Sweden, principal investigator and sponsor of the study. “Vitamin D is also an
important part of the treatment. The aim of the combination treatment is to stop
or delay the autoimmune attack of the pancreatic insulin producing cells.”

Diamyd® has shown an overall 16% efficacy (p=0.10) in a European Phase III trial
and a good safety profile. Data from clinical trials shows that Diamyd®
activates components that down-regulate the immune system as well as components
that increase inflammation in type 1 diabetes. By combining the diabetes vaccine
with etanercept, the inflammatory response is reduced and the diabetes vaccine’s
down-regulating, tolerance-inducing effect can have a greater impact. In turn,
vitamin D further down-regulates the immune system’s inflammatory components in
order to strengthen the regulatory effect of the diabetes vaccine. Both vitamin
D and etanercept are also considered to have a direct positive effect on the
beta cells.

EDCR will be conducted at nine pediatric diabetes clinics throughout Sweden. It
is an open label study, meaning that all participants will receive active
treatment. The participants will first receive treatment with vitamin D and
etanercept for the duration of one month. Two injections with Diamyd® will then
be administered one month apart. Treatment with etanercept will continue for a
total period of 90 days, and the vitamin D therapy for 15 months. An initial
safety evaluation will take place six months after all patients have been
included. The participants will subsequently be monitored for another 24 months.

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.

Six researcher-initiated clinical studies with Diamyd® in different treatment
regimens are ongoing:

  · 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 in April 2015 the initial six
-month results, focusing on immunological markers, were presented. 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 and is 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 comprises
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 and is led by Professor Johnny Ludvigsson. The first
patient was included in February 2015.

  · Diamyd®/GABA. A placebo-controlled study, where Diamyd® is being tested in
combination with GABA. The study 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 study is taking place in the US and is 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 and is 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 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 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 and is led by Professor
Johnny Ludvigsson. The first patient was included in May 2015.

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.