Diamyd Medical (formerly issued positive long-term results from a phase IIb trial of Diamyd, GAD-65), recombinant glutamic acid decarboxylase (GAD) delivered with alum for injection, for the treatment of type I diabetes. This randomized study enrolled seventy pediatric and adolescent subjects in Sweden.
The subjects received two single injections of Diamyd or placebo. The primary endpoint for the trial was the preservation of beta cell function as measured by C-peptide.
Thirty months after the first injection, preservation of insulin was significantly higher in subjects receiving Diamyd, both in the fasting state and after meal stimulation, compared with placebo-treated subjects.
Diamyd also increased GAD antibody levels at fifteen and twenty one months post-injection. Based on the data, phase III trials are planned.
The GAD gene technology was originally developed by the University of California, Los Angeles (UCLA). In 1997, BioSyn was granted an exclusive worldwide license to UCLA's GAD technology.