Clarifications regarding article in the medical journal Läkemedelsvärlden
In an article published today in the medical journal “Läkemedelsvärlden”, Professor Johnny Ludvigsson is interviewed regarding a trial with Diamyd Medical’s study drug Diamyd® (GAD65). The article deals with an investigator initiated trial, ie, a trial run by a researcher/university which is then the Sponsor of the study. The investigator initiated trial is led by Professor Johnny Ludvigsson at Linköping University. In the trial Diamyd® is tested to be administered into the lymph node. Diamyd Medical's role in the trial is to provide the study drug Diamyd®, safety reporting, and financial support. Professor Ludvigsson/Linköping University is responsible for the implementation of the study, which includes activities such as recruitment, control, monitoring of patients and analysis.
Diamyd Medical is currently involved in six investigator initiated studies with Diamyd®. In the article in Läkemedelsvärlden, Professor Ludvigsson says that he tries new regimes of GAD65. This refers to various methods to administer the study drug and in combination with other drugs, in the ongoing, investigator initiated studies with Diamyd® in which Professor Ludvigsson is Principal Investigator and Sponsor; besides the trial DIAGNODE, also DIABGAD and EDCR IIa.
Information not previously announced by Diamyd Medical is that 10 patients out of a total of 15 are now enrolled in the DIAGNODE trial. Diamyd Medical announced on October 24, 2016, interim results for the first six patients in the trial.
In the article, Professor Ludvigsson also mentions that that he aims to conduct a comprehensive, phase II study.
The ambition of drug development is to managing projects to the next clinical phase and finally to market. Diamyd Medical has not decided on such a new clinical trial.
DIAGNODE-1 is an open label pilot study, comprising a total of fifteen 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.
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®, an antigen-specific immunotherapy based on the exclusively licensed GAD-molecule. At this time six clinical studies are ongoing with Diamyd®. GABA constitutes alongside with the diabetes vaccine a key asset in Diamyd Medical and the Company uses its GABA in-licensed technology to develop a proprietary 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 Stockholm First North under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser.
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