Diamyd Medical agrees on new GABA/GAD study

Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced
that the Company has signed an agreement with Uppsala University and Uppsala
University Hospital to conduct a clinical study with the diabetes vaccine
Diamyd® combined with one or several GABA-related substances for which the stem
cell researcher Professor Per-Ola Carlsson will be the Principal Investigator.
The planned researcher-initiated combination study will be discussed with the
Swedish Medical Products Agency this spring and is the first of its kind where
GABA combined with the diabetes vaccine Diamyd® will play a large role in the
treatment of type 1 diabetes patients who have had the disease for a longer
period of time but still have some residual insulin secretion left. It differs
thereby from other studies where the treatment usually is initiated early in the
disease process.

Professor Per-Ola Carlsson, stem cell researcher and endocrinologist at Uppsala
University Hospital will be the Principal Investigator of the study, while
Uppsala University will be represented by the GABA expert Professor Bryndis
Birnir, who is also a member of Diamyd Medical’s Scientific Advisory Board.

“The research around GABA and GABA-related drugs and how these affect endogenous
insulin secretion has been our main focus for the last couple of years, and we
have now reached a point where we can transfer this to clinical studies, the
goal for our team for a long time,” says Professor Bryndis Birnir, Department of
Neuroscience; Physiology; Molecular Physiology and Neuroscience at Uppsala
University.

The intention is that the GABA-related molecules will support beta cell function
and simultaneously decrease the autoimmune inflammation so that a fertile milieu
is generated for the GAD-based Antigen Based Therapy Diamyd® to induce tolerance
for a longer period of time.

“This new concept, to attack type 1 diabetes with both GAD and GABA-related
drugs is interesting,” says Professor Per-Ola Carlsson, Department of Medical
Cell Biology, Uppsala University and Department of Medical Sciences,
Transplantation and Regenerative Medicine, Uppsala University Hospital. “If we
with this regimen can stop the autoimmune attack on the insulin-producing beta
cells, it may, together with our other approach – to increase beta cell mass
through transplantation with autologous stem cells – eventually become what will
lead to a cure for the disease.”

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 five patients
between the ages of 18 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. A study-expansion application has been submitted to
the Swedish Medical Products Agency.

  · 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. A first interim report is planned in the
first quarter of 2016.

  · 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 39% 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.