Clinical study with Diamyd Medical’s diabetes vaccine fully recruited

All participants have been included in a Phase II clinical study, DIABGAD-1, in
which Diamyd Medical’s diabetes vaccine Diamyd®, in a unique combination with
other drugs, is tested in children and adolescents recently diagnosed with type
1 diabetes. The first results from the researcher initiated study will thereby
be available in the beginning of 2015.
The study, DIABGAD-1, which is the first study of its kind, combines the
diabetes vaccine Diamyd® with vitamin D and the anti-inflammatory drug
ibuprofen. The Phase II study also evaluates the effect of a double dose of
Diamyd® and the protein GAD, which is the active substance in Diamyd®. The
purpose of the treatment is to preserve the body's own insulin producing
capacity and ability to control the blood sugar level in children and
adolescents newly diagnosed with type 1 diabetes.

The study will continue for a total of 30 months after all participants have
been included, with a first analysis focusing on immunological markers already
after 6 months. Since the final participant now has been included, the first
analysis will be initiated at the end of 2014 and the results can be presented
in the beginning of 2015.

“We strongly believe in attacking the disease process underlying type 1 diabetes
simultaneously from several angels through the combination of our diabetes
vaccine Diamyd® with other therapeutics, and this is one of the first such
studies in the world,” says Peter Zerhouni, President and CEO of Diamyd Medical.
“I am very happy and grateful that so many children and adolescents with their
families have chosen to participate in the study and also for the strong
commitment from the clinical researchers and other staff.”

The study is conducted at nine pediatric diabetes clinics in Sweden. It is
researcher initiated and led by Professor Johnny Ludvigsson at Linköping
University. The clinics have now included a total of 64 children and
adolescents, between 10 and 18 years of age, recently diagnosed with type 1
diabetes.

“I am extremely excited this important study is now fully recruited,” says
Professor Johnny Ludvigsson at Linköping University, principal investigator and
sponsor of the study. “The aim of the combination therapy is to create favorable
conditions for the diabetes vaccine Diamyd® to take effect by temporarily dampen
the inflammation in the pancreas with ibuprofen, while vitamin D is believed to
strengthen the part of the immune system that Diamyd® should stimulate. In this
study we also try to shorten the study period by analyzing immunological markers
already after 6 months, which will provide new and important insights for the
further development of the diabetes vaccine.”

About DIABGAD-1
DIABGAD-1 is a double-blind, randomized and placebo-controlled Phase II study
including a total of 64 participants between 10 and 18 years old, newly
diagnosed with type 1 diabetes. The study will comprise a total of 30 months,
with a first analysis focusing on immunological markers after 6 months. Four
different treatment groups, each including approximately 15 participants, will
be evaluated: the first group will receive one prime injection of Diamyd® and a
booster injection 4 weeks later, combined with ibuprofen for 90 days and vitamin
D for 450 days; the second group will receive one prime injection of Diamyd® and
a booster injection 4 weeks later, and vitamin D for 450 days; the third group
will receive two prime injections of Diamyd® and two additional booster
injections 4 weeks later, and vitamin D for 450 days; and the fourth group will
receive placebo only (no active substance). Chance will decide which treatment
group a patient is randomized to and nobody knows who is randomized to which
group. The study is conducted at pediatric diabetes clinics in Malmö, Lund,
Halmstad, Uddevalla, Örebro, Linköping and Stockholm. The study is funded by
research grants, while Diamyd Medical is responsible for providing study drug
and certain other costs, and can utilize the study results.

About type 1 diabetes and the diabetes vaccine Diamyd®
Type 1 diabetes is an autoimmune form of diabetes that ordinarily occurs in
children. The disease is caused by an autoimmune attack, which means that the
body’s own immune system destroys the insulin-producing beta cells in the
pancreas that control the blood sugar. To survive with type 1 diabetes intensive
treatment with insulin is needed every day for life, either through injections
or an insulin pump, and the blood sugar must be checked through blood samples 7
-10 times a day. Both too much and too little insulin can lead to
unconsciousness and even death. Type 1 diabetes can also cause serious long-term
complications, such as blindness, cardiovascular disease, nephropathy and
neuropathy. Today there is no cure for type 1 diabetes and the disease cannot be
prevented.

Diamyd Medical’s diabetes vaccine Diamyd® is intended to prevent, delay, or stop
the autoimmune attack on the beta cells. The aim is to prevent the onset of
diabetes, or to preserve the body’s remaining capacity to regulate blood sugar.
Studies have shown that even a very limited preservation of endogenous insulin
secretion and a slight improvement of the blood sugar control significantly
reduce the risk of both acute and long-term diabetes complications.
For further information, please contact:
Peter Zerhouni, President and CEO Diamyd Medical AB
Phone: +46 8 661 00 26. E-mail: press@diamyd.com
About Diamyd Medical
Diamyd Medical is a Swedish diabetes company. The Company’s primary development
project consists of the GAD-based diabetes vaccine Diamyd®for the treatment and
prevention of autoimmune diabetes. Two Swedish researcher-initiated Phase II
studies with Diamyd®are currently ongoing. One study evaluates whether the
diabetes vaccine can prevent type 1 diabetes in children who are at high risk of
developing the disease, while the other study evaluates whether Diamyd®in
combination with vitamin D and ibuprofen can preserve the body's own ability to
regulate the blood sugar level in children and adolescents newly diagnosed with
type 1 diabetes.

In 2013 the Company concluded an exclusive licensing agreement with the
University of California in Los Angeles (UCLA) relating to a patent portfolio
for the therapeutic use of GABA (gamma-aminobutyric acid) and GABA receptor
agonists for the treatment and prevention of type 1 and type 2 diabetes and
other inflammation-related conditions, such as metabolic syndrome, rheumatoid
arthritis and allergies.

In April 2014, Diamyd Medical entered an agreement with a group of founding
partners and Karolinska Institutet Holding AB, in order to establish a
commercial cord blood bank in Sweden for private family saving of umbilical cord
blood and other sources of stem cells. The intention is also to collect and make
available stem cells from umbilical cord tissue for research purposes in order
to advance the fields of stem cells and regenerative medicine, including
research within type 1 diabetes.

Diamyd Medical also has interests in the gene therapy company Periphagen
Holdings, Inc. (US) and Companion Medical, Inc. (US).

Diamyd Medical’s Series B share is traded on NASDAQ OMX First North under the
ticker DMYD B. Remium Nordic AB is the Company’s Certified Adviser. Further
information is available on the Company’s website: www.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.