Diamyd Medical (STO:DIAMB)(Pink Sheets:DMYDY) announces today that one
hundred study participants have been included in the ongoing US Phase
III study, DiaPrevent. The global Phase III program with the company’s
lead drug candidate Diamyd® has thereby enrolled more than 430 children
newly diagnosed with
type 1 diabetes in Europe and the USA.
One hundred patients are now enrolled in the company’s US Phase III
study called DiaPrevent at 33 diabetes centers throughout the USA and
more sites will be added. The study will include 320 children and
adolescents between 10 and 20 years of age, recently diagnosed with type
1 diabetes.
“After FDA’s approval to include children down to 10 years of age, which
is enabling us to add pediatric sites, the recruitment rate has shown a
remarkable increase. Numerous sites have been added with more to come.
Last month one new patient per day received their first injection and
the recruitment rate is accelerating," says Elisabeth Lindner, CEO and
President of Diamyd Medical.
More than 430 children have received Diamyd® or placebo in the global
Phase III program. To date, no serious side effects related to the drug
have been reported, which supports the strong safety profile seen in
previous studies with Diamyd®.