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news.Hollis-Eden Pharmaceuticals has been given FDA clearance to proceed with human trials of its investigational compound Neumune as a treatment for radiation sickness, such as that resulting from a nuclear explosion.
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The study will be designed to evaluate the safety of the drug while determining the concentration of Neumune that can be achieved in human blood. This 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.
The drug is being developed under an FDA 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.
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.
Hollis-Eden is also pursuing an advance purchase contract to provide Neumune to the US government’s strategic national stockpile for use by the military, first responders and civilians who may be at risk of radiation injury. The chairman of Hollis-Eden said he believes Neumune could be a valuable countermeasure to attack from weapons of mass destruction and said the company would be advancing talks with government agencies as soon as possible.