Press Release, May 14, 2009
Diamyd Medical reported today that 166 out of a total of 320 patients, who are
part of the European Phase III study of the Diamyd® diabetes vaccine, have now
been included in the study. Discussions with regulatory agencies are ongoing
regarding how the brisk rate of recruitment in Europe can best be utilized in
Diamyd's global Phase III program. The company estimates that the program will
be fully recruited during 2009.
The global Phase III program includes two studies with respectively 320 patients
in Europe and 320 in the United States ages 10 to 20. The objective of the
program is to evaluate the ability of the Diamyd® vaccine to halt or slow the
autoimmune attack on insulin-producing beta cells, thereby preserving the body's
own ability to produce insulin in children and adolescents with recent onset
type 1 diabetes.
“The rate of recruitment is now excellent. During a short period of time we have
nearly doubled the recruitment of patients for our European Phase III study,”
says Elisabeth Lindner, President and CEO of Diamyd Medical. “This enables us to
increase the proportion of European patients in the global Phase III program,”
Lindner continues.
Initially, the US study is only recruiting patients ages 16 to 20, an age group
with a limited patient population. Diamyd Medical is pursuing discussions with
the regulatory agencies about expanding the age range in the US to 10-20, and
about altering the design of the Phase III program, so that countries with the
fastest rate of patient recruitment can be utilized to the greatest extent.
For additional information, please contact:
Elisabeth Lindner, President and CEO Diamyd Medical AB (publ.)
Tel: +46 (0)8 6610026
For pictures and press material, please contact:
Alexandra Fleetwood, Director Communications Diamyd Medical AB (publ.),
alexandra.fleetwood@diamyd.com
Tel: +46 (0)8 661 0026
About Diamyd Medical
Diamyd Medical is a Swedish biopharmaceutical 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 the OMX
First North (ticker: DIAM B) and on OTCQX in the US (ticker: DMYDY)
administered by the Pink OTC Markets and the Bank of New York (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)
