The diabetes vaccine Diamyd® in new study to stop type 1 diabetes in children

Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) informs that
DiAPREV-IT 2 has started. In this new study, the second of its kind, the
diabetes vaccine Diamyd® is tested to prevent or delay the onset of type 1
diabetes in children at very high risk of presenting with the disease.
The first participant out of 80 has now been included in DiAPREV-IT 2, a placebo
controlled Phase II study where the diabetes vaccine Diamyd® is administered
with the aim of preventing or delaying type 1 diabetes. The children
participating in the study are seemingly healthy, but have been identified to
have a very high risk of presenting with type 1 diabetes. The participants will
also be supplemented with Vitamin D with the aim of strengthening the efficacy
of the diabetes vaccine.

The autoimmune process causing type 1 diabetes starts before the appearance of
any clinical symptoms of the disease. Years or months prior to symptoms of
insulin deficiency the immune system has already started to attack the insulin
producing cells in the body. During this period there are not yet any noticeable
symptoms of the disease but the autoimmune process can be detected by screening
for certain markers in the blood. In large screening studies at Lund University,
Sweden, children with these markers have been identified and those children will
thus most probably present with symptomatic type 1 diabetes.

“We have noted a great interest to participate in the study, and there are many
candidates in line,” says Helena Elding Larsson, pediatrician in Malmö and
researcher at Lund University but also the lead investigator and sponsor for the
study. “It is very satisfying to be able to offer these children a study with
the aim of preventing or delaying the disease process.”

“Through a blood sample, it is today possible to identify individuals in which
the autoimmune process leading to type 1 diabetes has started,” says Åke
Lernmark, Professor of Experimental Diabetes Research at Lund University. “It is
important to intervene before it is too late and two injections with the
diabetes vaccine Diamyd®, which has been shown to be safe in studies with more
than 1000 diabetes patients, seem to be the most promising treatment today.”

The new study, DiAPREV-IT 2, is a complement to the ongoing study DiAPREV-IT.
When the children are included in the study they will be stratified according to
which of the early stages of the autoimmune process leading to type 1 diabetes
they are in. The first stage comprises children with two or more auto-antibodies
directed at their own insulin-producing cells, but with normal glucose
metabolism. The second stage comprises children with both auto-antibodies and
impaired glucose metabolism. Vitamin D supplement is given to down-regulate the
immune system’s inflammatory components in order to increase the diabetes
vaccine’s tolerance-inducing effect regarding the preservation of the body’s
insulin-producing capacity.

The study is double-blind and placebo-controlled. Half of the participants will
be randomized to receive two injections of Diamyd® and half will be randomized
to receive placebo (non-active substance), but no one will know which treatment
group they are randomized to until the study is completed after 5 years. The
children that present with symptomatic type 1 diabetes during the study will
receive injections of active Diamyd® after diagnosis, regardless of what they
received as preventative treatment. This way, the effect of the diabetes vaccine
can be monitored also in new-onset patients.

DiAPREV-IT and DiAPREV-IT 2 are conducted by a research team at Lund University
and co-funded by research grants. Diamyd Medical is providing the study drug and
has the right to utilize the findings of the studies in a potential future
market registration.

About type 1 diabetes
Type 1 diabetes is an autoimmune disease where the immune system attacks the
patients’ own insulin producing beta cells. By analyzing markers in the blood it
is possible to identify persons in whom this autoimmune process is ongoing,
although has not yet caused clinical symptoms of diabetes. When type 1 diabetes
presents with clinical symptoms, patients must be treated daily, for the rest of
their lives, with insulin to sustain life. The importance of finding a cure is
high for the world’s health care systems and the wellbeing of patients. The
annual market for an easy to use, successful therapeutic is estimated to several
billion dollars.

About the diabetes vaccine Diamyd®
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 1,000 diabetes
patients and has shown a good safety profile. 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. Five clinical studies with
Diamyd® are now ongoing and one 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 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 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 fighting type 1 diabetes and to working toward a
cure for the disease. Its projects include development of combination regimens
with the GAD-based diabetes vaccine Diamyd® 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, 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.