Stockholm, August 24, 2000
Diamyd diabetes vaccine approved for Phase II
Diamyd Medical AB, (traded at Stockholm SBI-list, Reuter: DIAMb.epfn; Bloomberg: Diam b SS), announces that regulatory authorities in Sweden (MPA) has approved the company´s application to conduct a Phase II study with its diabetes vaccine Diamyd.
"In a year where much promising news has been published with respect to islet transplantation as a cure for type 1 diabetes, little has been optimistically noted regarding the development of agents capable of actually preventing the disease. This announcement surely forms the basis for the latter" says Professor Mark Atkinson, American Diabetes Association Professor for Diabetes Research at The University of Florida.
"GAD vaccination was more effective in protecting the insulin-producing cells from destruction in diabetes-prone mice than vaccination with any other autoantigen tested and we are pleased that this technology is brought one step further" says Professor Daniel Kaufman, Department of Molecular & Medical Pharmacology, UCLA, Los Angeles.
Professor Carl-David Agardh, Department of Endocrinology, Malmö University Hospital, Sweden will lead the study. There are around 100 million non-insulin dependent (type 2) diabetes patients in the world of whom 10% have antibodies to GAD (LADA patients). The risk that these 10% develop insulin dependent (type 1) within a certain time is 85 per cent. The Phase II study that has now been approved aims to ascertain if the development of insulin dependent diabetes in LADA patients can be prevented. The study is expected to take about a year. "The differentiation between type 2 diabetes and LADA patients is well advanced in Sweden," says Agardh. "This makes the country suitable for carrying out this Phase II study and patients can be recruited in a short time".
"With the Phase II approval, chances to reach the market with the Diamyd diabetes vaccine has significantly improved. We may also see an increased sales of our GAD- antibody and other diabetes diagnostic tests" says Anders Essen-Möller, CEO of Diamyd Medical.
For further information, please contact:
Diamyd Medical AB
115 25 Stockholm
tel: +46-8-6610026; fax: +46-8-6616368
This information includes statements concerning present status and forward-looking items and is to the ?best of knowledge? of the management of Diamyd Medical only and the actual status and results achieved by the Company may differ materially from these statements. The Company assumes no obligation to update these statements to reflect actual results, changes in assumptions or changes in other factors affecting such statements.