Hollis-Eden Pharmaceuticals, Inc. has been allowed to start with Phase I human clinical trials with its investigational compound Neumune in the US pursuant to an Investigational New Drug (IND) 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, a company release says.
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.
As previously reported, Hollis-Eden has conducted and reported on dose-ranging radiation studies with Neumune in over 200 non-human primates. These studies have demonstrated beneficial effects of Neumune on a number of important haematology parameters that are critical in ARS, and Neumune treated animals in these studies also experienced a survival advantage relative to placebo treated animals.
According to the company release, 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. By comparing the concentration of Neumune that can be achieved in humans to that which has already been established in non-human primates, the Company 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 US are designed to complement the clinical program that has already commenced in the Netherlands.
ARS, also referred to as radiation sickness, is an acute illness caused by high doses of radiation exposure over a significant portion of the body in a relatively short time period. This exposure results in the depletion of haematopoietic stem cells and progenitors, resulting in severe neutropenia and thrombocytopenia. Severe neutropenia can significantly increase an individual's susceptibility to life threatening infections, while thrombocytopenia increases the risk of bleeding. Currently, there are no therapeutics approved to mitigate ARS.