Press Release, February 13, 2009
DIAMYD® APPROVED FOR GROUNDBREAKING STUDY IN NORWAY
Diamyd Medical reports today that a prevention study with the Diamyd® diabetes
vaccine has been approved by the Norwegian Medicines Agency. As previously
communicated on December 9, 2008, the objective of the study is to investigate
the disease process before type 1 diabetes onset and if treatment with the
Diamyd® diabetes vaccine stops the process.
In type 1 diabetes, the insulin-producing capacity is gradually destroyed by the
immune system. Already before any symptoms of diabetes appear the disease can be
detected through analysis of biomarkers in the blood. If Diamyd® treatment is
initiated at this early stage it is likely that the onset of type 1 diabetes can
be delayed or prevented.
A unique feature of the study is that tissue samples from the pancreas are
taken. Analysis of these tissue samples can provide direct insight into how
Diamyd® reduces the destruction of beta cells, i.e. the cells that produce
insulin. This study includes 90 adults at high risk for developing type 1
diabetes and an additional 60 recent-onset type 1 diabetes patients.
“This is a major step in diabetes research. We have never previously studied
what actually happens to the beta cells during onset of type 1 diabetes,” says
Professor Knut Dahl-Jørgensen who will lead the study. “In addition to studying
how the Diamyd® vaccine affects the insulin producing cells in people at high
risk for developing type 1 diabetes, as well as how Diamyd® preserves the
insulin producing capacity in recent-onset patients, we will specifically
investigate whether type 1 diabetes may be caused by viral infection.”
”This study may be groundbreaking,” says Elisabeth Lindner, President and CEO of
Diamyd Medical. ”This is the first time our diabetes vaccine Diamyd® will be
used in an attempt to prevent the disease progression in persons at risk for
type 1 diabetes.”
The study will be conducted by a leading diabetes research group at Oslo
University Hospital, Oslo Diabetes Research Centre in Norway, under the
direction of Professor Knut Dahl-Jørgensen. The study is financed by
Helse-SørØst, Oslo University Hospital and University of Oslo, Norway. The
clinical study protocol is developed by the Norwegian research group in
cooperation with Diamyd Medical and Professor Johnny Ludvigsson, Linköping
University, Sweden.
The Diamyd® vaccine is being tested in the company's own Phase III studies in
Europe and the US for children and adolescents with recent-onset type 1
diabetes.
For more information, please contact:
Elisabeth Lindner, President and CEO Diamyd Medical AB (publ.),
elisabeth.lindner@diamyd.com
Phone: +46-8-661 00 26
For pictures and press material, please contact:
Sonja Catani, Chief Communications Officer Diamyd Medical AB (publ.),
sonja.catani@diamyd.com
Phone: +46-8-661 00 26
This information is disclosed in accordance with the Securities Markets Act, the
Financial Instruments Trading Act or demands made in the exchange rules.
Diamyd Medical is a Swedish biopharmaceutical company focusing on development of
pharmaceuticals for treatment of autoimmune diabetes and its complications. The
company's most advanced project is the GAD-based drug Diamyd® for type 1
diabetes for which Phase III trials are ongoing in both the US and Europe.
Furthermore, the company has started clinical studies within chronic pain, using
its Nerve Targeting Drug Delivery System (NTDDS). The company has also
out-licensed the use of GAD for the treatment of Parkinson's disease.
Diamyd Medical has offices in Sweden and in the US. The share is quoted on the
OMX Stockholm Nordic Exchange (ticker: DIAM B) and on OTCQX in the US (ticker:
DMYDY) administered by the Pink Sheets and the Bank of New York (PAL). Further
information is available on the company's web site: www.diamyd.com.
Diamyd Medical AB (publ.)
Linnégatan 89 B, SE-115 23 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8
661 63 68
E-mail: info@diamyd.com. VATno: SE556530-142001.
(www.omxnordicexchange.com ticker: DIAM B; www.otcqx.com ticker: DMYDY)
