Hollis-Eden Initiates Phase I Clinical Study With Neumune
Hollis-Eden Pharmaceuticals has initiated the first in a series of Phase I safety and pharmacokinetic (PK) clinical trials with Neumune (HE2100), its investigational immune regulating hormone for the treatment of acute radiation syndrome.
This first study is being conducted in the Netherlands. The company also stated that it continues to expect to file an investigational new drug application with the FDA in the first half of 2005 to initiate clinical studies in the U.S.
Safety and PK study results are expected to be available in a time frame that enables the company to initiate a pivotal efficacy study in nonhuman primates in the second half of 2005. Hollis-Eden is developing Neumune under the FDA Animal Efficacy Rule designed for medical countermeasures to weapons of mass destruction. Pursuant to this rule, for indications in which it would be unethical to conduct efficacy studies in humans (as is the case with radiation injury), approval may be granted on the basis of efficacy in relevant animal species and safety in humans.
The purpose of the Phase I studies, in addition to analyzing safety, is to determine the concentration of Neumune that can be achieved in human blood. This PK information can then be used in selecting the final dose for the pivotal efficacy study in nonhuman primates. Under the Animal Efficacy Rule, matching the drug levels in humans with that which produces efficacy in the appropriate animal species is a requirement for approval.