Diamyd Medical receives approval from the Swedish Medical Products Agency for the Phase II trial DIAGNODE-2
The Swedish Medical Products Agency has approved the conduction of DIAGNODE-2, a pivotal follow-up clinical trial in children and adolescents recently diagnosed with type 1 diabetes.
The placebo-controlled Phase II trial DIAGNODE-2 will investigate an innovative and patent-pending concept, where the diabetes vaccine Diamyd® is administered directly into the lymph node. Submission of applications to the respective Competent Authorities in Spain and the Czech Republic are ongoing, as well as to the relevant Ethics Committees. The clinical trial is expected to commence patient recruitment by the autumn of 2017.
The placebo controlled clinical trial DIAGNODE-2, where the diabetes vaccine Diamyd® is administered directly into lymph nodes, will include approximately 80 patients aged 12-24 years, recently diagnosed with type 1 diabetes. The patients will be followed for 15 months with the aim to evaluate the safety of the combination treatment and the effect on the immune system and the insulin producing capacity. The Coordinating Investigator for the trial is Professor Johnny Ludvigsson at Linköping University.
About Diamyd Medical
Diamyd Medical is dedicated to finding a cure for diabetes and other serious inflammatory diseases through pharmaceutical development and investments in stem cell and medical technology.
Diamyd Medical develops the diabetes vaccine Diamyd®, for antigen-specific immunotherapy based on the exclusively licensed GAD-molecule. Four clinical trials are ongoing with Diamyd®. The Company's trial DIAGNODE-2, where the diabetes vaccine is administered directly into the lymph node, is expected to start recruiting patients in the fall. An exclusive license for GABA for the treatment of diabetes and inflammatory diseases constitutes alongside with the diabetes vaccine a key asset in Diamyd Medical and the Company uses its GABA in-licensed technology to develop a GABA drug product. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB. Diamyd Medical also has holdings in the medtech company Companion Medical, Inc., San Diego, USA and in the gene therapy company Periphagen, Inc., Pittsburgh, USA.
Diamyd Medical’s B-share is traded on Nasdaq First North under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser.
For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
Diamyd Medical AB (publ)
Kungsgatan 29, SE-111 56 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: email@example.com. Reg. no.: 556242-3797. Website: www.diamyd.com.
This information is information that Diamyd Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 17:00 CET on June 27, 2017.