Diamyd Medical submits application to the Medical Products Agency for the DIAGNODE-2 trial
Diamyd Medical today announced that the Company has submitted an application to the Swedish Medical Products Agency to conduct DIAGNODE-2, a pivotal follow-up clinical trial in children and adolescents recently diagnosed with type 1 diabetes. The placebo-controlled Phase II trial will investigate an innovative and patent-pending concept, where the diabetes vaccine Diamyd® is administered directly into the lymph nodes. The trial will be conducted in Sweden, Spain and the Czech Republic at selected diabetes clinics, with established contacts and interests to achieve the best possible cooperation and patient recruitment.
“Our application for a follow-up clinical Phase II trial with the diabetes vaccine Diamyd® is an important milestone," says Ulf Hannelius, CEO of Diamyd Medical. “I am very pleased with how the preparations progress and impressed by the efficiency and dedication that permeates the work of all involved.”
Diamyd Medical collaborates with the global contract research company TFS Trial Form Support International, and now follows the applications to have the trial approved by the respective Competent Authorities in Spain and the Czech Republic, as well as to the relevant Ethics Committees. DIAGNODE-2 is expected to start recruiting patients this autumn 2017. The trial is financed by Diamyd Medical, sponsor of the trial, through funds from the ongoing rights issue with the subscription period 10 - 24 May 2017.
About DIAGNODE-2
DIAGNODE-2 includes approximately 80 patients aged 12-24 years, recently diagnosed with type 1 diabetes, and the patients will be followed for 15 months. The aim of the trial is to evaluate the effect of the treatment in preserving the patients' insulin producing capacity. The trial is based on the ongoing open-label pilot trial DIAGNODE?1, where preliminary results indicate that the intralymphatic administration of the diabetes vaccine Diamyd® appears to increase the effect of the vaccine as compared to injecting under the skin (subcutaneous). 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®, an antigen-specific immunotherapy based on the exclusively licensed GAD-molecule. Five clinical trials 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.
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 08:30 CET on May 22, 2017.