All 12 patients in DIAGNODE-1, an open clinical pilot trial, where the diabetes vaccine Diamyd® is given directly into the lymph node, have now completed their 6-month visit. The database was locked today and the data analysis process can thus begin. Preliminary results will be reported before Christmas.
DIAGNODE-1 is an open label pilot trial, comprising a total of twelve patients between the ages of 12 and 30 with type 1 diabetes, where a low dose of the diabetes vaccine Diamyd® is administered directly into the lymph node in combination with treatment with vitamin D. Twelve patients have been followed for 6 months from inclusion in the trial, that is, 3 months after the third injection with diabetes vaccine Diamyd® (4μg per dose) directly into the lymph node.
DIAGNODE-2 is based on the ongoing open label pilot trial DIAGNODE-1, where preliminary results show a positive clinical progression and desired immunological response as the diabetes vaccine Diamyd® is given directly into the lymph node. DIAGNODE-2 encompasses approximately 80 patients from Spain, the Czech Republic and Sweden, aged 12 – 24 years, recently diagnosed with type 1 diabetes. The patients will be followed for 15 months with the aim to evaluate the remaining insulin producing capacity. Coordinating Investigator 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. Besides the Company’s own European Phase-II trial DIAGNODE-2, where the diabetes vaccine is administered directly into the lymph node, there are four investigator initiated clinical trials ongoing with Diamyd®. Diamyd Medical also develops Remygen®, a proprietary GMP manufactured oral GABA-based study drug. An investigator initiated placebo controlled trial with GABA and Diamyd® in patients recently diagnosed with type 1 diabetes is ongoing at the University of Alabama at Birmingham. Exclusive licenses for GABA and positive allosteric modulators of the GABAA receptor for the treatment of diabetes and inflammatory diseases constitutes alongside with the diabetes vaccine Diamyd® and Remygen® key assets. Diamyd Medical is also one of the major shareholders in the stem cell company NextCell Pharma AB and 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
E-mail: [email protected]
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 14:10 CET on November 30, 2017
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