Diamyd close to important milestone
Diamyd Medical announces today that 90 percent of the total 320 children and
adolescents with type 1 diabetes due to participate in the company's European
Phase III study with the diabetes vaccine Diamyd® have now been included and
have received injections of Diamyd® or placebo. The company expects all
participants to have been included in the study by November 2009.
Diamyd Medical is conducting a global Phase III program with the diabetes
vaccine Diamyd® comprising a study in nine countries in Europe and a study in
the US. In each study 320 children and adolescents aged 10-20 newly diagnosed
with type 1 diabetes will take part.
"We are now close to our first important milestone in the Phase III program,"
says Elisabeth Lindner, President and CEO of Diamyd Medical. "We expect the
study to be fully recruited by November 2009."
"The results will be analyzed during spring 2011, when all patients have
participated in the study for 15 months."
The purpose of the study is to investigate whether the Diamyd® vaccine can delay
or stop the break-down of beta cells in the pancreas and hence preserve the
body's own ability to control the blood sugar in patients newly diagnosed with
type 1 diabetes. This could in turn reduce the risk for acute and long-term
In the study, two thirds of participants are receiving the Diamyd® vaccine and
one third is receiving placebo (an inactive substance). The study is conducted
at 70 clinics in Europe.
As previously announced, the company is investing in accelerated patient
recruitment for the parallel US Phase III study with the diabetes vaccine
Diamyd® through recruitment campaigns and an increase in the number of
participating US pediatric diabetes clinics.
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.)
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.)
Linnégatan 89 B, SE-115 23 Stockholm, Sweden. Tel: +46 (0)8 661 00 26, Fax: +46
(0)8 661 63 68
E-mail: firstname.lastname@example.org. VAT no: SE556530-142001.