Diamyd(R) Diabetes Vaccine Receives Approval to Start Phase III Trials in Europe
Diamyd Medical AB (http://www.omxgroup.com, OMX: DIAM B; http://www.otcqx.com, OTC: DMYDY)
STOCKHOLM, Sweden, March 19 /PRNewswire-FirstCall/ -- Diamyd Medical
(OMX: DIAM B)(OTC: DMYDY)announced today that the Swedish Medical Products
Agency (MPA) has approved the Company's application to commence Phase III
studies with the therapeutic diabetes vaccine Diamyd(R).
'I am extremely glad that we now can offer our recently diagnosed type 1
diabetes patients the possibility to participate also in the European study,'
says Professor Johnny Ludvigsson, Linkoping, Sweden, Principal Investigator
for the study.
Diabetes teams from approximately 20 Swedish pediatric clinics will meet
in Linkoping, Sweden on April 4 to go through details for the study, which
will comprise 306 new onset type 1 diabetes patients. Diamyd Medical is
planning to file clinical trial applications in another 3-4 European
countries and include additionally 20 clinics in the study.
'The approval from the Swedish MPA is another important step in the
development of Diamyd(R) towards the market,' says Elisabeth Lindner,
President and CEO of Diamyd Medical. 'Last week we received authorization
from the FDA to start a parallel Phase III trial in the US, and together with
TrialNet's planned study in the US, the interest in Diamyd is strong. We
receive daily inquiries from parents of patients wanting to participate in
our studies.'
