HOLLIS-EDEN CLEARED TO COMMENCE TRIALS WITH NEUMUNE

Hollis-Eden Pharmaceuticals announced the FDA has determined that it is safe to proceed with Phase I human clinical trials with its investigational compound Neumune in the U.S. pursuant to an investigational new drug application it recently filed with the agency.

A similar Phase I clinical trial for Neumune is currently ongoing in the Netherlands. Neumune is being developed for the treatment of Acute Radiation Syndrome (ARS). ARS is a potentially lethal condition caused by high-dose radiation exposure that might result from a nuclear or radiological terrorist attack or from an accident at a nuclear facility.

Under the Phase I clinical trial program, in addition to analyzing safety, initial studies are being conducted to determine the concentration of Neumune that can be achieved in human blood. This pharmacokinetic information can then be used in selecting the final dose for the pivotal efficacy study in non-human primates, as well as a larger human clinical trial to demonstrate safety. By comparing the concentration of Neumune that can be achieved in humans to that which has already been established in non-human primates, Hollis-Eden expects to be able to match the dose most likely to achieve efficacy in the pivotal studies with a dose that is achievable and tolerable in humans. The studies to be conducted in the U.S. are designed to complement the clinical program that has already commenced in the Netherlands.