STOCKHOLM, March 14 /CNW/ - Diamyd Medical AB (http://www.omxgroup.com,
ticker: DIAM B; http://www.otcqx.com, ticker DMYDY). The FDA has given Diamyd
Medical permission to start a Phase III clinical study in type 1 diabetes
patients in the US with the therapeutic diabetes vaccine Diamyd(R).
(Logo: http://www.newscom.com/cgi-bin/prnh/20080314/297194 )
"We are eager to start this study and to be able to offer this promising
drug to our newly diagnosed type 1 diabetes patients", says Professor Jerry
Palmer, University of Washington in Seattle, USA, who will be the Lead
Investigator for the US study.
"We are extremely pleased with this progress," says Elisabeth Lindner,
President and CEO of Diamyd Medical. "Over the past months we have received
dozens of patient inquiries with requests to participate in our Phase III type
1 diabetes studies in the US and in Europe. It is very satisfying to be able
to start the studies now."
The US Phase III study will enroll 306 new-onset type 1 diabetes
patients, who are within 3 months of diagnosis. Results of the study will be
analyzed 15 months after all patients have been enrolled. A parallel Phase III
study is planned to be conducted in Europe and together, pending a positive
outcome of the trials, these pivotal studies can be used for market
registration of the drug.
In a previous Phase II study in young type 1 diabetes patients, Diamyd(R)
showed efficacy in preserving the patients' own insulin producing capacity for
at least 30 months. No safety concerns have to date been reported in any
clinical study with Diamyd(R).
Company website: http://www.diamyd.com
Diamyd Medical AB (publ). Linnegatan 89 B, SE-115 23 Stockholm, Sweden
Disclaimer: This document contains certain statements relating to the
progress, timing and completion of our research, development and clinical
trials. These statements can be affected by inaccurate assumptions or by known
or unknown risks and uncertainties. Diamyd Medical undertakes no obligation to
publicly update such statements, whether because of new information, future
events or otherwise, nor does Diamyd Medical give any guarantees that the
statements, given or implied, are correct. This document is a translation from
the Swedish original. No guarantees are made that the translation is free from
For further information:
For further information: Stockholm office, Elisabeth Lindner, CEO and
President, +46-8-661-0026, firstname.lastname@example.org; Anders Essen-Moller,
Chairman, +46-8-661-0026, email@example.com