FDANews

HOLLIS-EDEN FILES IND FOR NEUMUNE TRIAL

Hollis-Eden Pharmaceuticals has filed an investigational new drug (IND) application with the FDA to begin Phase I clinical trials with Neumune HE2100) in patients at high risk of developing hospital-acquired infections.

The purpose of these initial trials will be to establish the safety of the drug in this population, and to help identify the optimal patient subsets for further study in Phase II efficacy trials. Neumune is already the subject of an open IND for use in treating acute radiation syndrome, a condition that can increase an individual's susceptibility to life-threatening infections and risk of bleeding.