New method to give Diamyd® will be tested in adults with type 1 diabetes

Diamyd Medical (NASDAQ OMX First North, Ticker: DMYD B) informs that a new way
to give Diamyd® will be tested in a clinical study with five adults newly
diagnosed with type 1 diabetes. The investigator initiated study has been
approved by the Swedish MPA.
In analogy to the development in allergy therapy, where the administration of
allergen into lymph nodes has significantly improved the efficacy, Diamyd® will
in this study be administered directly into lymph nodes in combination with
treatment with vitamin D.

“This is an innovative approach that may become important both for the treatment
of type 1 diabetes as well as other autoimmune diseases,” says Professor Johnny
Ludvigsson at Linköping University, principal investigator of the study. “We
have previously shown that Diamyd® has some effect in terms of preservation of
the insulin producing beta cells and now we are trying different ways to enhance
this effect. Direct intralymphatic administration is one such way. Combination
regimens with potentially effective molecules that fight the disease from other
angles is another way. Just as in cancer therapy, different combination regimens
must be tested to arrive at a cure of autoimmune diabetes.”

Diamyd® is an Antigen Based Therapy (ABT) developed for the treatment and
prevention of type 1 diabetes. The active ingredient is the autoantigen GAD.
Diamyd® has shown an overall 16% efficacy (p = 0.10) in a European Phase III
study and is intended to be included as a component in combination therapies for
the disease.

“Diamyd® is today the furthest developed ABT for the treatment and prevention of
type 1 diabetes,” says Anders Essen-Möller, Chairman of Diamyd Medical. “We have
identified several approved drugs that we believe act synergistically with our
ABT. A clinical study with Diamyd® in combination with ibuprofen and vitamin D
is ongoing and several others are being prepared.”

The new study, DIAGNODE, is an open label pilot study with five patients between
18 and 30 years of age who have been diagnosed with type 1 diabetes within 6
months. An initial evaluation will be made after 6 months, with a focus on
safety and immunological markers, and the patients will thereafter be followed
for another 24 months.

All five participants will receive a low dose (4μg) of Diamyd® in the lymph node
on three occasions. Diamyd® is in this study combined with a high dose of
vitamin D. The vitamin D is provided in order to down regulate the immune
system’s inflammatory components to thereby increase the ABT's tolerance
inducing effect in regard of preserving the patient's insulin producing
capacity.

About type 1 diabetes
Type 1 diabetes is an autoimmune disease where the immune system attacks the
patients’ own insulin producing beta cells. For these patients, daily treatment
with insulin is mandatory 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 Diamyd®
Diamyd® is a therapeutic under development for the treatment and prevention of
autoimmune diabetes. Diamyd® has been used in trials totaling more than one
thousand patients with an excellent safety profile. Diamyd has shown an overall
16% efficacy (p=0.1) versus placebo regarding preservation of the patients’
endogenous insulin secretion in a European Phase III trial and is currently
being further developed in combination regimens with other therapeutic
compounds. Diamyd® is easy to administer in any clinical setting.
For further information, please contact:
Anders Essen-Möller, Chairman Diamyd Medical AB
Phone: +46 70 55 10 679. E-mail: anders.essen-moller@diamyd.com
About Diamyd Medical

Diamyd Medical is dedicated to fight type 1 diabetes and to work towards a cure
for the disease. Diamyd Medical’s current projects include development of
combination regimens for arresting the successive destruction of insulin
producing beta cells using the Company’s GAD65-based diabetes vaccine Diamyd®,
such as Diamyd®+ Vitamin D with or without an anti-inflammatory compound; and
Diamyd®+ GABA, for which Diamyd Medical licenses exclusive intellectual rights
from the University of California in Los Angeles (UCLA). Diamyd Medical has
further acquired 46% of the stem cell company Cellaviva AB that is establishing
a Swedish commercial bank for private family saving of umbilical cord blood and
other sources of stem cells. Stem cells are required for 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.

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.