New analyses by international diabetes expertise provides strong support for the Diamyd® diabetes vaccine

Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) informs that
internationally leading researchers within the field of type 1 diabetes,
independently of Diamyd Medical, has reanalyzed results from previous clinical
studies with the Diamyd® diabetes vaccine using alternative statistical methods,
termed Bayesian analysis. In an abstract submitted to a scientific meeting the
authors conclude that the GAD-based diabetes vaccine Diamyd®, with very high
probability preserves patients’ insulin producing capacity and that the
continued development should aim to increase the efficacy.
The authors that include several of the most respected researchers within type 1
diabetes, Craig Beam, Colleen MacCallum, Kevan Herold, Diane Wherrett, Jerry
Palmer, Johnny Ludvigsson and the Type 1 Diabetes TrialNet Study Group, have
compiled the abstract entitled ”GAD65 Vaccination Probably Reduces Insulin Loss
in Recent Onset Type 1 Diabetes”.

“We are pleased to see that reevaluation of the recent studies with the GAD
-vaccine using Bayesian methods shows that the GAD-vaccine likely has a beta
cell preserving effect in new onset type 1-diabetes patients,” says Professor
Craig Beam, Division Director, Epidemiology and Biostatistics, at Western
Michigan University Homer Stryker MD School of Medicine in Kalamazoo, USA.
“Bayesian statistics is an emerging way of assessing probabilities and has now
permeated all the major areas of medical statistics, including clinical trials,
epidemiology, meta-analyses and more.”

”It is very encouraging that several prominent international researchers now
support the notion that antigen specific treatment with Diamyd® with very high
probability has an effect in type 1 diabetes,” says Professor Johnny Ludvigsson,
Linköping University, Sweden, who has been the Principal Investigator for
several of the previous studies. “We continue to study if combinations with
other drugs can strengthen the effect of GAD treatment in several new clinical
studies.”

In short the authors state the following in the abstract:

The GAD65 vaccine has been studied in several randomized controlled trials (1-3)
as an effective intervention for insulin preservation in Type 1-diabetes.
Reevaluation of the studies using Bayesian methods resulted for the initial
study (1), that the probability of a reduction in insulin loss (measured by
stimulated C-peptide) from GAD to be 99.38%. Bayesian analysis of the first
follow-up study (2) lowered the probability of reduced insulin loss from GAD to
68.82%. The second follow-up study (3) increased the probability of insulin-loss
reduction from GAD to over 97.00%. In sum, evidence from published randomized
controlled trials consistently suggest that the GAD vaccine probably acts to
lessen the loss of insulin production in the new onset Type 1 diabetic patient.
It is concluded that the entirety of published evidence points toward continued
investigation of the GAD vaccine and, specifically, into ways to increase its
effectiveness.

1.             Ludvigsson J, Faresjo M, Hjorth M, et al. GAD treatment and
insulin secretion in recent-onset type 1 diabetes. The New England journal of
medicine. Oct 30 2008;359(18):1909-1920.

2.             Wherrett DK, Bundy B, Becker DJ, et al. Antigen-based therapy
with glutamic acid decarboxylase (GAD) vaccine in patients with recent-onset
type 1 diabetes: a randomised double-blind trial. Lancet. Jul 23
2011;378(9788):319-327.

3.             Ludvigsson J, Krisky D, Casas R, et al. GAD65 antigen therapy in
recently diagnosed type 1 diabetes mellitus. The New England journal of
medicine. Feb 2 2012;366(5):433-442.

About the Diamyd® diabetes vaccine
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 1000 diabetes
patients. 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. Two clinical studies with Diamyd® are ongoing and an
additional four are 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 early stages of 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.

  · 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 and is in
the start-up phase.

  · DIAPREV-IT 2. A placebo-controlled study, where Diamyd® is being tested in
combination with vitamin D in children with early stages 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 and is in the start-up
phase.

  · 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 is in the
start-up phase.

  · 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 Diamyd® diabetes vaccine 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, Chairman, 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.