Diamyd US Phase III study well under way
Diamyd Medical 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.
For more information, please contact:
Elisabeth Lindner, President and CEO Diamyd Medical AB (publ.)
Phone: +46 8 661 0026
For pictures and press material, please contact:
Andreas Ericsson, Diamyd Medical AB (publ.)
andreas.ericsson@diamyd.com
Phone: +46 8 661 0026
About Diamyd Medical
Diamyd Medical is a Swedish diabetes company focusing on the development of
pharmaceuticals for the treatment of autoimmune diabetes and its complications.
The company's most advanced project is the GAD-based drug Diamyd® for type 1
diabetes. Phase III trials for this drug are in progress in both Europe and the
US. In addition, the company has initiated clinical studies in the US in the
area of 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. The company currently has three clinical-phase products.
Diamyd Medical has offices in Sweden and in the US. Shares are listed on Nasdaq
OMX in Stockholm (ticker: DIAM B) and on OTCQX in the US (ticker: DMYDY)
administered by the Pink OTC Markets and the Bank of New York Mellon (PAL).
Further information is available on the company's website: www.diamyd.com.
This information is disclosed in accordance with the Swedish Securities Markets
Act, the Swedish Financial Instruments Trading Act, or the requirements stated
in the listing agreements.
Diamyd Medical AB (publ.)
Karlavägen 108, SE-115 26 Stockholm, Sweden. Tel: +46 (0)8 6610026, Fax: +46
(0)8 661 63 68
E-mail: info@diamyd.com. VAT no: SE556530-142001.
