Diamyd-licensed technology cures diabetes in pre-clinical model

Diamyd Medical (NASDAQ OMX First North, Ticker: DMYD B) informs that researchers
at UCLA have confirmed earlier findings that combinations of GABA and Antigen
Based Therapy (ABT) works synergistically as a treatment in the NOD mouse model
of type 1 diabetes. Diamyd Medical is the exclusive licensee for the
commercialization of UCLA’s GABA technology for metabolic diseases including in
diabetes.
A recent paper (Tian, Dang, Kaufman, et al. Diabetes 2014;63:3128–3134) reports
that newly diabetic NOD mice have successfully been treated and some even cured
using a combination regimen consisting of GABA and Antigen Based Therapy (ABT).
The ABT used in the study was pro-insulin formulated in alum, while similar
results were obtained with GAD65 in alum as the ABT in a previous paper using an
islet transplantation NOD model (Tian, Dang, Kaufman. PLoS One 2011;6:e25337).
GAD65 is the active substance in Diamyd®, the Company’s ABT which is currently
being tested in children for the treatment and prevention of type 1 diabetes.

The findings provide proof-of-principle that combining ABT with an anti
-inflammatory agent, such as GABA, can effectively restore normoglycemia in
newly diabetic mice. The therapy is reported to preserve insulin producing cells
as well as to promote their replication. It is concluded in the new paper, that
the use of GABA in combination with an ABT may hold promise for type 1 diabetes
intervention in humans.

A group at the University of Alabama, Birmingham, in collaboration with Diamyd
Medical, is planning a randomized, double-blind, placebo-controlled clinical
study with the combination GABA and Diamyd® as ABT in patients with new onset
type 1 diabetes. Discussions with the FDA regarding the study design are
ongoing.

“Diamyd® is to our knowledge the world’s furthest developed ABT for type 1
diabetes,” says Anders Essen-Möller, Chairman of Diamyd Medical. “ABT is
considered an essential component of a future successful combination therapy for
this disease. Several combinations are being studied or are in the pipeline to
be studied and there is a good chance that Diamyd® will be the first ABT to
cross the winning line.”

Type 1 diabetes is an autoimmune form of diabetes 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 GABA
GABA stands for gamma amino butyric acid and is produced in the body as
glutamate is decarboxylased by the GAD enzyme. GABA is an important suppressive
and “calming” neurotransmitter. Recent pre-clinical findings support the use of
GABA as a synergistic component for treatment of autoimmune diabetes and beta
cell regeneration as well as for controlling inflammation, such as in rheumatoid
arthritis, metabolic syndrome and type 2 diabetes. Diamyd Medical has licensed
Intellectual Proprietary Rights from UCLA for these applications.

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=0.10) 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 for example 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.