Press Release, April 16, 2009
Diamyd Medical is conducting two clinical Phase III trials of
the Diamyd®
diabetes vaccine in children and adolescents with recent
onset type 1 diabetes:
one in the US and one in nine European countries. In
parallel the company is
discussing with the regulatory agencies about
combining the two trials into one
global trial.
In addition to reducing costs,
combining the trials would mean that countries
with the fastest rate of
patient recruitment could contribute to the greatest
extent. The Phase III
program encompasses ten countries: Italy, Finland, France,
the Netherlands,
Slovenia, Spain, the UK, Sweden, Germany and the US. The plan
is for the
global trial to serve as the basis for market approval in both Europe
and the
US. Diamyd Medical's continued intention is to report Phase III data
during the fourth quarter of 2010.
Patient recruitment is growing sharply at present, as more clinics are
being
added. There are currently 74 active recruiting clinics in the US
and Europe, 34
of which have joined since the beginning of the year.
“We estimate that the expanded number of clinics will
enable us to screen 100
children and adolescents in April,” says Elisabeth
Lindner, President and CEO of
Diamyd Medical.
For additional information, please contact:
Elisabeth Lindner, President and CEO
Diamyd Medical AB (publ.)
Tel: +46 (0)8 6610026
For pictures and press
material, please contact:
Alexandra Fleetwood,
Director Communications Diamyd Medical AB (publ.),
alexandra.fleetwood@diamyd.com
Tel: +46 (0)8 661 0026
About Diamyd Medical
Diamyd Medical is a Swedish biopharmaceutical company focusing on the
development of pharmaceuticals for the treatment of autoimmune
diabetes and its
complications. The company's most advanced project is the
GAD-based drug Diamyd®
for type 1 diabetes. Phase III trials for this drug are
in progress in both the
US and Europe. In addition, the Company has initiated
clinical studies in the US
in the area of chronic pain, using its Nerve
Targeting Drug Delivery System. 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. Shares are listed 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 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.)
Linnégatan 89 B, SE-115 23 Stockholm, Sweden. Tel: +46 (0)8
6610026, Fax: +46 8
661 63 68
E-mail: info@diamyd.com. VAT no: SE556530-142001.
(www.omxnordicexchange.com ticker: DIAM B;
www.otcqx.com ticker: DMYDY
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