10. March 2010 03:20
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®.
The global Phase III program aims to investigate whether Diamyd® can
halt or slow the autoimmune destruction of beta cells in type 1
diabetes, preserving the body's own ability to control blood sugar
levels. An improved blood sugar control reduces the risk for both acute
and long-term diabetes complications. Diamyd® has been shown, in Phase
II studies, to preserve the remaining beta cell function in children and
adolescents recently diagnosed with type 1 diabetes.
The DiaPrevent study centers were opened for children as young as 10
years of age during autumn 2009 after previously having included only
age 16-20 years. New study sites are added as they receive ethics board
approvals.
More information about the DiaPrevent study can be found at www.diaprevent.com
and at www.diaprevent.diamyd.com.
The parallel European Phase III study was fully recruited in November
2009 and results are expected during spring 2011.
Source Diamyd Medical
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