Ten percent screened in European phase III study of Diamyd® diabetes vaccine
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.”