9 January 2012 - A researcher-initiated Phase II trial of Diamyd Medical's diabetes vaccine Diamyd has met its recruitment target enrolling 50 healthy children aged four and older with a high risk of developing Type 1 diabetes, the Swedish biotech company said in a regulatory filing.

The prevention study, DiAPREV-IT, which was initiated in 2009, seeks to establish whether preventive vaccination with Diamyd can defer or stop the progress of the disease so that the children do not develop clinical symptoms of Type 1 diabetes.

The double-blind, placebo-controlled Phase II trial is being performed by a research group at Lund University and is led by Helena Elding Larsson, a pediatrician in Malmo and researcher at Lund University. The study is financed by research grants, but Diamyd Medical has taken part in the design of the trial and can use the trial results.

The children recruited in the study have an ongoing autoimmune process, where their blood sugar-regulating beta cells in the pancreas are being destroyed by their own immune system. The children can develop Type 1 diabetes if the destruction of the beta cells is not halted. Preventive treatment with Diamyd aims to intervene in the autoimmune process at an early stage, thus preventing the disease from developing.

The children participating in the trial have auto-antibodies against GAD65 and at least one other auto-antibody. They will be monitored for five years by sampling and glucose tolerance tests to assess the beta cell function. The first results will be available in 2015.

Diamyd has previously been assessed in a Phase III trial of children already diagnosed with Type 1 diabetes. This study did not achieve the primary efficacy endpoint of preserving beta cell function. Safety data showed that Diamyd was well tolerated with similar number of adverse events registered across all treatment groups.