Ten Percent Screened In European Phase III Study Of Diamyd® Diabetes Vaccine

Main Category: Diabetes
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials
Article Date: 03 Oct 2008 - 1:00 PST

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Ten percent of the children participating in the European phase III study have been screened and about a dozen have received their first injection.

"The studies are progressing as planned and we expect to keep on schedule," says Erika Hillborg, Director of clinical trials at Diamyd Medical. "The Swedish part of the study began right before summer and we are just starting in Holland, England, Germany, France, Finland, Slovenia, Italy, and Spain. We have already injected the first patients in the parallel phase III study in the US."

Strategically, the most important date for the study is when the last patient receives his/her first injection (last patient in) since this determines the results date. If all goes as planned, the study's 15-month results will come in during the latter part of 2010, after which the market registration application for the Diamyd® vaccine can be completed.

"Diamyd Medical could have the world's first diabetes vaccine out on the market in 2011," says Elisabeth Lindner, President and CEO. "We are going through big changes and are preparing the company to become a pharmaceutical company. There is enormous potential for the future."

Diamyd Medical is a Swedish biopharmaceutical company focusing on development of pharmaceuticals for treatment of autoimmune diabetes and its complications. The company's most advanced project is the GAD-based drug Diamyd® for type 1 diabetes and for which Phase III trials are ongoing in both the US and Europe. Furthermore, the company has initiated clinical studies within 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.

Diamyd Medical has offices in Sweden and in the US. The share is quoted 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 web site: http://www.diamyd.com

This information is disclosed in accordance with the Securities Markets Act, the Financial Instruments Trading Act or demands made in the exchange rules.

Diamyd Medical