|[January 30, 2013]
Diamyd Medical: New Clinical Study with Diamyd's Diabetes Vaccine
STOCKHOLM --(Business Wire)--
Diamyd Medical AB (STO:DIAMB) (Pink Sheets:DMYDY) reports that a new
clinical study with the diabetes vaccine Diamyd® is planned to start in
February 2013. In the study Diamyd® will be tested in a unique
combination with other drugs, aiming to potentiate the effect of the
diabetes vaccine. The Company has entered into an agreement with
Linköping University to conduct the researcher-initiated study. The
study has been approved by the Swedish Medical Products Agency.
The study, which is the first study of its kind, combines the diabetes
vaccine Diamyd® with relatively high doses of vitamin D and the
anti-inflammatory drug ibuprofen. The purpose of the treatment is to
preserve the body's own ability to control the blood sugar level in
children and adolescents newly diagnosed with type 1 diabetes.
"I am excited to start this new important study and I strongly believe
in combining Diamyd® with vitamin D and anti-inflammatory drugs," says
Professor Johnny Ludvigsson at Linköping University, principal
investigator and sponsor of the study. "The aim of the combination is to
create favorable conditions for the diabetes vaccine Diamyd® to take
effect by temporarily dampen the inflammation in the pancreas, while
vitamin D is believed to strengthen the part of the immune system that
Diamyd® should stimulate."
The study is called DIABGAD-1 and will also evaluate the effect of a
double dose of Diamyd® and the protein GAD, which is the active
substance in Diamyd®. The study will include 60 children and adolescents
in Sweden and it will be conducted at pediatric diabetes clinics in
Malmö, Lund, Halmstad, Kalmar, Jönköping, 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.
"Diamyd Medical's collaboration with the researchers in this pilot study
is a good example of our strategy to evaluate different treatment
concepts with the diabetes vaccine Diamyd® through externally funded
clinical trials," says Peter Zerhouni, President and CEO of Diamyd
Medical. "We strongly believe in attacking the disease process in type 1
diabetes from several sides simultaneously through the combination of
different drugs, and this is one of the first such studies in the world.
By following immunological markers the study period has been shortened
and it will provide new and important insights for the further
commercial development of our diabetes vaccine."
DIABGAD-1 is a double-blin, randomized and placebo-controlled Phase II
study including a total of 60 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
already after 6 months. The study has been approved by the Swedish
Medical Products Agency and is scheduled to start screening patients in
the beginning of February 2013. Four different treatment groups, each
including 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 booster
injections 4 weeks later, and vitamin D for 450 days; and the fourth
group will receive placebo only.
About type 1 diabetes and the diabetes vaccine Diamyd®
Type 1 diabetes, also known as juvenile diabetes, is a lifelong and very
serious disease that often affects young children. It is an autoimmune
disease caused by the body's own immune system attacking and destroying
the insulin secreting beta cells in the pancreas, resulting in insulin
deficiency and inability to control blood sugar levels. There is
currently no treatment on the market addressing the autoimmune process
that causes type 1 diabetes.
Current treatment strategies involve controlling the blood sugar level
by adding external insulin, either by injections or by insulin pump. The
aim is to reach as stable a blood sugar level as possible, neither too
high nor too low. Consistently high and fluctuating blood sugar levels
cause diabetes complications, including kidney and eye damage,
cardiovascular disease, nerve damage as well as severe hypoglycemia and
Diamyd Medical's drug development in diabetes originates from the
protein GAD, which is the active substance in the Company's diabetes
vaccine Diamyd® for the prevention and treatment of autoimmune diabetes.
Treatment with Diamyd® is intended to prevent, delay, or stop the
autoimmune attack on the beta cells. The aim is to prevent the onset of
autoimmune diabetes, or to preserve the body's capacity to regulate
blood sugar. Studies have shown that even a very small preservation of
endogenous insulin secretion and slight improvement of the blood sugar
control can significantly reduce the risk of both acute and long-term
Since 2009 the diabetes vaccine Diamyd® is being evaluated in a Swedish
researcher-initiated Phase II study, DiAPREV-IT. That study includes a
total of 50 children aged four and older who, through analysis of
diabetes markers in the blood, are demonstrated to be at high risk of
developing type 1 diabetes, but have not yet presented with disease. The
purpose of the study is to evaluate whether preventive treatment with
Diamyd®, compared to placebo, can delay or halt the progression of the
disease so that the children do not develop clinical symptoms of type 1
diabetes. The first results are expected to be compiled in 2015.
About Diamyd Medical
Diamyd Medical was founded in 1996 and is active in the field of
pharmaceutical development. Diamyd Medical is headquartered in
Stockholm, Sweden. The Company's development project consists of the
protein GAD for the treatment and prevention of autoimmune diabetes. A
Swedish researcher-initiated Phase II study is ongoing to evaluate
whether GAD can prevent type 1 diabetes in children who are at high risk
of developing the disease.
Diamyd Medical also has holdings in the gene therapy company Periphagen
Holdings, Inc. (USA), the vaccine company Protein Sciences Corporation
(USA) and the diagnostics company Mercodia AB (Sweden).
Diamyd shares are listed on Nasdaq OMX (segment Small Cap) in Stockholm
(ticker: DIAM B) and on OTCQX in the US (ticker: DMYDY) administered by
the Pink OTC Markets and the Bank of New York Mellon (PAL). Further
information is available on the Company's website: www.diamyd.com.
This information is disclosed in accordance with the Swedish Securities
Markets Act, the Swedish Financial Instruments Trading Act, or the
requirements stated in the listing agreements.
Diamyd Medical AB (publ)
Karlavägen 108, SE-115 26 Stockholm, Sweden. Phone (News - Alert): +46 8 661 00 26,
Fax: +46 8 661 63 68
E-mail: firstname.lastname@example.org. Reg. no:
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