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The article is now available on the journal's web site(http://www.nejm.org) and will be in print on October 30. It presents theresults of the concluded Phase II study of the Diamyd(R) diabetes vaccine.The article provides detailed information about the study, which showed thatDiamyd(R) helped children and adolescents with type 1 diabetes, whoparticipated in the study, retain the ability to produce their own insulinwithout causing any serious side effects.
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"The results show that treatment with Diamyd(R) clearly has a positiveeffect on the course of type 1 diabetes, the most common serious, chronicdisease among children," says Professor Johnny Ludvigsson at LinkopingUniversity Hospital, who is first author of the article and responsible forthe study.
The New England Journal of Medicine is the world's oldest and mostinfluential medical journal, recognized for the high scientific standards ofits content. Every year they receive more than 5,000 scientific articles fromaround the world, but only a fraction of them are selected for publication.Articles published in the journal are often noted over the entire world andreach many researchers, doctors and other interested parties.
"This is the ultimate scientific validation of the study results," saysPeter Zerhouni, Director of Business Development at Diamyd and co-author ofthe article. "The material was reviewed and scrutinized several times byexperts from different areas before publication."
"That our results are considered to be of such quality and clinical valuestrengthens our position in the medical and industrial worlds," saysElisabeth Lindner, president and CEO of Diamyd. "We are now moving forwardpreparing the market introduction of Diamyd(R)."
About the article:
"GAD Treatment and Insulin Secretion in Recent-Onset Type 1 Diabetes"
J Ludvigsson et al., N Engl J Med 2008;359 (Epub ahead of print10.1056/NEJMoa0804328)
About Diamyd(R) Type 1:
Diamyd(R) Type 1 is the treatment of recently diagnosed patients with theDiamyd(R) diabetes vaccine. Diamyd(R) Type 1 is a simple treatment withoutany serious side effects. This treatment is now being tested in Phase IIIstudies in Europe and the US. The company plans to complete the applicationfor market approval in late 2010. The annual market for Diamyd(R) Type 1 isestimated at about one billion dollars.
About the mechanism of action:
Type 1 diabetes is an autoimmune disease in which the body's own immunesystem attacks the cells in the body that produce insulin. The activeingredient in Diamyd(R) is glutamic acid decarboxylase (GAD), which is adominant antigen in type 1 diabetes. By treating with GAD formulated as avaccine, the patient's immune system is affected in such a way that it downregulates the attack on the insulin-producing cells. Stopping this autoimmuneprocess is the cornerstone in curing type 1 diabetes.
Immunological analyses from the Phase II study as presented in the NewEngland Journal of Medicine help to form an understanding of the Diamyd(R)vaccine's mechanism of action. A significant increase in regulatory T-cellactivity was seen, which is considered decisive in counteracting the courseof autoimmune diseases.
About the Phase II study:
The Phase II study now being presented comprised 70 patients aged 10-18with type 1 diabetes. The patients, who received two injections of Diamyd(R),retained their own ability to produce insulin significantly better than thepatients, who received placebo. The best effect was seen in patients, forwhom treatment was begun shortly after diagnosis, since those patients stillretained a significant amount of the cells that produce insulin. The resultsindicate that the Diamyd(R) vaccine may also be effective in preventing type1 diabetes.
About ongoing Phase III studies with Diamyd(R) Type 1:
There are currently two Phase III studies in progress: one in Europe andone in the US. The studies apply to children and adolescents diagnosed withtype 1 diabetes within the last three months.
This information is disclosed in accordance with the Securities MarketsAct, the Financial Instruments Trading Act or demands made in the exchangerules.
Diamyd Medical is a Swedish biopharmaceutical company focusing ondevelopment of pharmaceuticals for treatment of autoimmune diabetes and itscomplications. The company's most advanced project is the GAD-based drugDiamyd(R) for type 1 diabetes and for which Phase III trials are ongoing inboth the US and Europe. Furthermore, the company has initiated clinicalstudies within chronic pain, using its Nerve Targeting Drug Delivery System(NTDDS). The company has also out-licensed the use of GAD for the treatmentof Parkinson's disease.
Diamyd Medical has offices in Sweden and in the US. The share is quotedon 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:http://www.diamyd.comFor more information, please contact: Elisabeth Lindner, President and CEO Diamyd Medical AB (publ.), [email protected] , Phone: +46-8-661-0026. For pictures and press material, please contact: Sonja Catani, Chief Communications Officer Diamyd Medical AB (publ.), [email protected] , Phone: +46-8-661-00-26.
SOURCE Diamyd Medical AB (publ)
