Hollis-Eden gets FDA approval for anti-infective trial

Hollis-Eden’s goal in this trial will be to establish the safety of Neumune in this population, and to help identify the optimal patient subsets for further study in phase II efficacy trials.

Healthcare-associated infections present a major problem for patients who are immune suppressed as a result of illness, injury, advanced age, or the stress of hospitalization. Approximately two million people contract healthcare-associated infections each year in the US, leading to an estimated 90,000 deaths annually.

Due to the emergence of drug resistant strains of bacteria, many hospital infections can no longer be treated effectively with commonly used antibiotics. In the US alone, the healthcare costs associated with these infections exceed $4.5 billion annually.

Pursuing healthcare-associated infections as a therapeutic application for Neumune is a natural progression from Hollis-Eden’s development program for Acute Radiation Syndrome (ARS), a condition that can increase an individual’s susceptibility to life-threatening infections and risk of bleeding. In this program, Neumune has been evaluated in studies in healthy and radiation-induced immune suppressed rhesus monkeys and in phase I clinical studies in healthy human subjects. Results from these studies suggest Neumune may have activity that could protect immune suppressed individuals from healthcare-associated infections through stimulation of innate immunity – the body’s first line of defense.

“Having demonstrated in other indications the ability of our compounds to stimulate host immunity to increase resistance to disease and infections, we are enthusiastic about the potential of developing Neumune for this significant unmet medical need,” said Richard Hollis, chairman and CEO of Hollis-Eden Pharmaceuticals.