Diamyd Logo
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

diabetes.

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.)

andreas.ericsson@diamyd.com

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

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 6610026, Fax: +46 (0)8 661 63 68

E-mail: info@diamyd.com. VAT no: SE556530-142001.

(www.omxnordicexchange.com

ticker: DIAM B; www.otcqx.com ticker: DMYDY)

Attachments:



Bookmark and Share