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Diamyd Discussing Potential Consolidation of Phase III Trials

Thu. April 16, 2009; Posted: 04:25 AM
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STOCKHOLM, Sweden, Apr 16, 2009 (GlobeNewswire via COMTEX) -- DMYDY | Quote | Chart | News | PowerRating -- Diamyd Medical is conducting two clinical Phase III trials of the Diamyd(r) diabetes vaccine in children and adolescents with recent onset type 1 diabetes: one in the U.S. 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 U.S. The plan is for the global trial to serve as the basis for market approval in both Europe and the U.S. 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 U.S. 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 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(r) for type 1 diabetes. Phase III trials for this drug are in progress in both the U.S. and Europe. In addition, the Company has initiated clinical studies in the U.S. 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 U.S. Shares are listed on the OMX Stockholm Nordic Exchange (ticker: DIAM B) and on OTCQX in the U.S. (Pink Sheets: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.)
 Linnegatan 89 B, SE-115 23 Stockholm, Sweden.
 Tel: +46 (0)8 6610026, Fax: +46 8661 63 68
 E-mail: info@diamyd.com. VAT no: SE556530-142001.
 (www.omxnordicexchange.com) (ticker: DIAM B) (www.otcqx.com)
 (Pink Sheets:DMYDY)

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: Diamyd Medical AB

Diamyd Medical AB
          Elisabeth Lindner, President and CEO  
          +46 (0)8 6610026
For full details for DMYDY click here.

    


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