Diamyd Medical plans first interim report from open label pilot study EDCR IIa with the diabetes vaccine Diamyd® in the first quarter of 2016
Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced that a first six month interim report comprising five patients treated with etanercept and the diabetes vaccine Diamyd® is intended to be presented during the first quarter of 2016. The study is open labeled, meaning not placebo-controlled, and is conducted at nine pediatric diabetes clinics in Sweden. Professor Johnny Ludvigsson, Linköping University is principal investigator and sponsor of the study.
EDCR IIa is an open label trial, where Diamyd® is combined with etanercept and vitamin D. The trial comprises 20 patients between the ages of 8 and 18, newly diagnosed with type 1 diabetes, and will continue for a total of 30 months. The aim of the trial is to evaluate the safety of the combination treatment and the effect on the immune system and the patients’ insulin producing capacity. The trial is led by Professor Johnny Ludvigsson at Linköping University, Sweden. The first patient was included in May 2015, and now half of the subjects are included. The study is conducted at pediatric diabetes clinics in Linköping, Lund, Uddevalla, , Malmö, Helsingborg, Eskilstuna, Örebro, Västerås and Stockholm.
EDCR IIa is included in a series of combination studies with the diabetes vaccine Diamyd® to enhance the effect (16%, p=0.1) previously seen in a European Phase III study including 334 newly diagnosed type 1 diabetes patients. EDCR IIa is conducted at nine different pediatric diabetes clinics in Sweden.
“We are excitedly looking forward to report certain interim results from this study during the first quarter of 2016,” says Anders Essen-Möller, President and CEO of Diamyd Medical. “EDCR IIa is a small study which is not placebo-controlled. As such, it is known that all patients have received active treatment which enables analysis of groups of for example five patients, to be performed after their respective six month visits, without affecting the scientific value.”
About Diamyd Medical
Diamyd Medical is dedicated to finding a cure for autoimmune diabetes through pharmaceutical development and investments in stem cell and medical technology.
Diamyd Medical develops the diabetes vaccine Diamyd®, an Antigen Based Therapy (ABT) based on the exclusively licensed GAD-molecule. The Company’s licensed technologies for GABA and Gliadin have also potential to become key pieces of the puzzle of a future solution to prevent, treat or cure autoimmune diabetes, and also certain inflammatory diseases. At this time six clinical studies are ongoing. Diamyd Medical is one of the major shareholders in the stem cell company Cellaviva AB, active in private family saving of stem cells from the umbilical cord. Stem cells can be expected to be used in Personalized Regenerative Medicine (PRM), for example for restoration of beta cell mass in diabetes patients where the autoimmune component of the disease has been arrested by ABT.
Diamyd Medical’s B-share is traded on Nasdaq Stockholm First North under the ticker DMYD B. Remium Nordic AB is the Company’s Certified Adviser.
For further information, please contact:
Anders Essen-Möller, President and CEO
Phone: +46 70 55 10 679. E-mail: anders.essen-moller@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.
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