Swine influenza vaccination might have had an impact on treatment with the diabetes vaccine Diamyd® in Phase III clinical trial
A scientific article published today in Diabetologia supports the notion that vaccination against influenza A (H1N1) 2009, commonly known as the Swine flu, might have had a negative impact on the outcome of the treatment with the diabetes vaccine Diamyd® in the European Phase III clinical trial conducted in 2008-2011. In the patient group receiving two doses of Diamyd®, there was greater preservation of residual insulin production when there was at least 150 days between the Swine flu vaccination and the first injection of Diamyd®.
In the article published today in the scientific journal Diabetologia, the authors show an association between vaccination against the influenza A (H1N1) 2009 (Swine flu) and the effect of the Diamyd®-vaccination in patients participating in the placebo controlled Diamyd® European Phase III trial. The study that was conducted in 2008-2011 did not reach the primary endpoint, although a clinical effect was observed in several subgroups.
“The results published in Diabetologia are of importance and shed new light on one of the possible factors underlying the Phase III trial outcome,“ says Johnny Ludvigsson, Professor at Linköping University and Coordinating Investigator of the study.
Antibodies to GAD65 were higher in all patients given the diabetes vaccine Diamyd®, and for which the time between receiving the vaccination against the Swine flu and the Diamyd®-vaccine was longer than 210 days. In the patient group receiving two doses of Diamyd® there was greater preservation of residual insulin production and a more pronounced Th2 character of the immune response when there was at least 150 days between the Swine flu vaccination and the first injection of Diamyd®.
“One known element of uncertainty that has been discussed, is the possible impact another vaccination may have when given during the treament with the diabetes vaccine Diamyd® ,” says Ulf Hannelius, CEO of Diamyd Medical. “These results provide valuable new facts that will be considered in ongoing and future planning of clinical trials.”
The article is available on http://link.springer.com/article/10.1007/s00125-017-4263-x
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 five 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 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: ulf.hannelius@diamyd.com
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: info@diamyd.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 12:00 CET on March 31, 2017.
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