Published on May 11th, 2017 | by TFS0
Diamyd Medical enters agreement with TFS for the DIAGNODE-2 trial
Diamyd Medical has contracted the global contract research company (CRO) TFS Trial Form Support International for the implementation of DIAGNODE-2, a clinical trial in children and young adults recently diagnosed with type 1 diabetes.
The placebo-controlled Phase II trial is a pivotal follow-up trial with an innovative and patent-pending concept where the diabetes vaccine Diamyd® is administered directly into the lymph node. The trial, which is expected to start recruiting patients this fall, is made possible by the aggressive rights issue approved at yesterday’s extraordinary general meeting.
DIAGNODE-2 will be conducted at a number of selected clinics in some countries in Europe including Sweden. The trial includes approximately 80 patients aged 12-24 years, newly diagnosed with type 1 diabetes, and will follow the patients for 15 months. The aim of the trial is to evaluate the effect of the treatment in preserving the patient’s own insulin production. The Coordinating Investigator for the trial is Professor Johnny Ludvigsson at Linköping University.
”We are very pleased to have TFS as our partner for this decisive trial with our diabetes vaccine”, says Ulf Hannelius, President and CEO of Diamyd Medical. “We have a very good cooperation with TFS and their extensive experience in running multinational clinical studies in diabetes is of course valuable. Our highest mutual priority is now to advance the trial as efficiently and quickly as possible.”
The process of having the trial approved by the Competent Authorities and Ethics Committees in each country is underway and the trial is expected to start in the fall of 2017. DIAGNODE-2 will be financed by Diamyd Medical, sponsor of the trial, through a newly approved rights issue with subscription period 10 – 24 May 2017.
The decision to implement the trial is based on highly promising preliminary clinical results from the ongoing open-label DIAGNODE-1 trial in which children and adolescents recently diagnosed with type 1 diabetes are given Diamyd® directly into the lymph node. The clinical effect of preserving the patient’s own insulin production is estimated to be significantly improved as the diabetes vaccine Diamyd® is given directly into the lymph node, as compared to injecting it under the skin as in previous Phase III trials. The Diamyd Medical patented concept can be compared to the development of allergy treatment where it has been found that the administration of allergen into the lymph node significantly improves the treatment effect.
Photo Ulf Hannelius: Johan Ohlsson