SAN DIEGO--(BUSINESS WIRE)--May 31, 2005--Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) today announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin Phase I clinical trials in human volunteers with NEUMUNE(TM) (HE2100) in the United States. 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. The Department of Health and Human Services (HHS) has recently updated on its website the process of procuring under Project BioShield therapies to treat ARS, indicating that it anticipates releasing by July 2005 a draft Request for Proposal (RFP) (http://www2.eps.gov/spg/HHS/OOS/OASPHEP/Reference%2DNumber%2DRFI%2DORDC%2D05%2D01A/Synopsis.html).
Hollis-Eden is developing NEUMUNE under an FDA rule (the Animal Efficacy Rule) designed for medical countermeasures to weapons of mass destruction. According to this rule, for indications in which it would be unethical to conduct efficacy studies in humans (as is the case with radiation injury), marketing approval may be granted based on the demonstration of efficacy in relevant animal species and successful completion of Phase I safety trials in humans.
