Diamyd® Phase III study approved for younger patients in the US

Press Release, June 8, 2009

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 Medical is conducting two parallel Phase III studies, one in Europe and

one in USA, comprising a total of 640 patients. The objective of the studies is

to evaluate the ability of the Diamyd® 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


The European study, which is 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 both #2431 at the ADA's 69th Scientific

Sessions in New Orleans, USA.

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.),


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

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: 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

Phone: +46 (0)8 6610026, Fax: +46 (0)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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