Diamyd to include children and accelerate patient recruitment in US Phase III study with the Diamyd® diabetes vaccine
Diamyd to include children and accelerate patient recruitment in US Phase III
study with the Diamyd® diabetes vaccine
Diamyd Medical reported today that from September 1, children from 10 years of
age with type 1 diabetes will be included in the company's US Phase III study of
the Diamyd® diabetes vaccine. The company is also trebling the number of clinics
and is investing in expanded recruitment activities in the US.
Diamyd Medical's Phase III study of the Diamyd® diabetes vaccine in the US has
so far only been open to patients with type 1 diabetes aged between 16 and 20
years. From September 1, 2009, the study will also be open to children in the
age range 10 to 15 years. Following the FDA's decision in June to reduce the
lower age limit from 16 to 10 years, the company has concentrated on contacting,
visiting and applying for ethical approval for pediatric diabetes clinics
throughout the US, and will now begin recruiting younger children. The company
will retain 13 of the existing clinics and is negotiating with around 30 new
pediatric diabetes clinics in an effort to gradually increase the number of
participating clinics to 40.
Diamyd previously announced the evaluation of a consolidation of the company's
two Phase III studies. On the advice of the FDA, a decision has now been made to
keep the two Phase III studies in Europe and the US separate, but to investigate
the practical possibilities of including European patients in the US study,
which is conducted under the supervision of the FDA.
"We are now working diligently to recruit patients in the US," says Elisabeth
Lindner, CEO and President of Diamyd Medical. "Most people who develop type 1
diabetes do so between the ages of 10 and 15 years, which is why the speed of
recruitment may increase rapidly in the US study when we include this age group
and expand the number of clinics. Our plan is still to obtain market approval
for Diamyd® in 2012."
Diamyd Medical is conducting a global Phase III program for the Diamyd® diabetes
vaccine, which includes a total of 640 children and adolescents newly diagnosed
with type 1 diabetes. The program comprises one study involving nine European
countries and one parallel study in the US. The purpose of the Phase III studies
is to confirm and evaluate the ability of the Diamyd® vaccine to halt or slow
the autoimmune destruction of the body's insulin-producing cells, thereby
preserving the body's own ability to produce insulin in people with type 1
In addition to the Phase III program, additional clinical trials with the
Diamyd® diabetes vaccine are conducted:
Long-term follow up of the children with type 1 diabetes, who participated in
the company's previously reported Phase II study, for the purpose of evaluating
the long-term effect of the Diamyd® vaccine.
A Phase II study in the US aiming to preserve the body's own ability to produce
insulin, as well as to further investigate the immunological mechanism of action
of the Diamyd® diabetes vaccine. This study is conducted by TrialNet/National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/National
Institutes of Health (NIH).
A Phase II study in the US aiming to stimulate regrowth of insulin-producing
cells. This study is conducted by the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK)/National Institutes of Health (NIH).
A Phase II study in Norway aiming to study the disease process of type 1
diabetes in adults with a high risk of developing the disease.
A Phase II study in Sweden at Malmö University Hospital, Lund University, aiming
to vaccinate children at high risk of developing type 1 diabetes, thereby
preventing the disease.
For additional information, please contact:
Elisabeth Lindner, President and CEO Diamyd Medical AB (publ.)
Tel: +46 (0)8 661 0026
For pictures and press material, please contact:
Andreas Ericsson, Diamyd Medical AB (publ.)
Tel:+46 (0)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
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 6610026, Fax: +46 (0)8 661 63 68
E-mail: email@example.com. VAT no: SE556530-142001.
ticker: DIAM B; www.otcqx.com ticker: DMYDY)