Diamyd(R) Phase III Study Approved for Younger Patients in the US



    STOCKHOLM, June 8 /CNW/ - Diamyd Medical reported today that the company
has received approval from the US Food and Drug Administration (FDA) to
include children with type 1 diabetes from 10 years of age in the company's
Phase III study with the diabetes vaccine Diamyd(R).

    (Logo: http://www.newscom.com/cgi-bin/prnh/20080314/297194 )

    Diamyd Medical is conducting two parallel phase III studies, one in
Europe and one in the USA, comprising a total of 640 patients. The objective
of the studies is to evaluate the ability of the Diamyd(R) vaccine to halt or
delay the autoimmune attack on the body's insulin-producing cells, thereby
preserving the body's own ability to produce insulin in children and
adolescents with recent-onset type 1 diabetes.
    The European study, which is being conducted in nine countries, is
approved for patients between 10 and 20 years of age, whilst the US study so
far has been approved only for patients 16 to 20 years, an age group with few
recent-onset type 1 diabetes patients. The company is, with the new approval,
allowed to begin enrollment of children from 10 years of age in the US phase
III study.
    "This is a big step forward giving us the opportunity to accelerate
patient recruitment in the US," says Elisabeth Lindner, President and CEO of
Diamyd Medical. "We are pleased that the approval comes now in connection with
the world's largest diabetes conference, the ADA's 69th Scientific Sessions,
which is currently ongoing in New Orleans."
    The company will now, in pace with Institutional Review Board (IRB)
approvals in USA, increase the number of American pediatric clinics in the
study. The application for market approval is, as before, planned for spring
2011.
    Diamyd Medical is represented at booth No. 2431 at the ADA's 69th
Scientific Sessions in New Orleans, USA.

    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(R) for type 1 diabetes. Phase III trials for this drug are in progress
in both Europe and the US. In addition, the company has started clinical
studies in the US in the area of 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. The company has currently three
clinical-phase products.
    Diamyd Medical has offices in Sweden and in the US. Shares are listed on
the Nasdaq OMX 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:
http://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.

    Photo: http://www.newscom.com/cgi-bin/prnh/20080314/297194





For further information:

For further information: Elisabeth Lindner, President and CEO Diamyd
Medical AB (publ.), Tel: +46(0)8-661-00-26. For pictures and press material,
please contact: Alexandra Fleetwood, Director Communications Diamyd Medical AB
(publ.), alexandra.fleetwood@diamyd.com, Tel: +46(0)8-661-00-26

Organization Profile

DIAMYD MEDICAL AB (PUBL)

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