Diamyd Files IND for Diabetes Vaccine Trial

Swedish drugmaker Diamyd Medical has filed an investigational new drug (IND) application with the FDA for a Phase III trial with the Diamyd therapeutic vaccine in recent onset Type 1 diabetes patients.

The vaccine has demonstrated significant efficacy in Phase II trials in preservation of beta cell function for at least 21 months. Additionally, no treatment-related serious adverse events have been observed, Diamyd said.

The company is planning similar applications for a parallel European Phase III trial and anticipates the Phase III studies may lead to market approval.