Diamyd Medical AB 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-blind, 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 ketoacidosis.
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
diabetes complications.
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.
For more 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 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: +46 8 661 00 26, Fax: +46 8
661 63 68
E-mail: info@diamyd.com. Reg. no: 556530-1420
