Diamyd's GAD65 Vaccine for New-Onset Type 1 Diabetes Disappoints in Clinical Trial

In recent news, Diamyd Medical released disappointing results from its European phase 3 trial of its self-titled Diamyd GAD65 vaccine for the treatment of new-onset type 1 diabetes. As background, GAD65 is a protein found on beta cells that is thought to be targeted by the immune system in the development of type 1 diabetes. By exposing the immune system to GAD65, the company hopes Diamyd will restore the immune system's ability to recognize GAD65 in a non-destructive manner, thereby slowing or halting further beta cell attack.

Although Diamyd delayed the progression of type 1 diabetes out to 30 months of follow-up in a previous smaller study, data from the 320-participant European trial did not provide as promising an outlook. In the European trial, individuals treated with Diamyd did not show a statistically significant preservation of beta cell function after 15 months of follow-up compared to placebo (inactive injections), although a small positive effect was seen. While these latest results are somewhat discouraging, we hope that the 320-participant US DiaPrevent study and/or extended 30-month follow-up data from the European trial (both expected to be released in 2012) will demonstrate some degree of beta cell preservation for individuals with new-onset diabetes. In addition, the Diamyd vaccine is also currently being evaluated in a separate, smaller clinical trial as a potential treatment to prevent type 1 diabetes from developing in high-risk individuals. --VW/OB