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news.Hollis-Eden Pharmaceuticals has filed an investigational new drug application with the FDA to begin phase I clinical trials with Neumune in patients at high risk of developing hospital-acquired infections.
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The initial trials are designed 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.
Neumune is already the subject of an open IND for use in treating acute radiation syndrome (ARS), a condition that can increase an individual’s susceptibility to life-threatening infections and risk of bleeding.
According to the company, of the 34 million patients admitted to US hospitals and healthcare facilities each year, approximately two million contract hospital-acquired infections, leading to an estimated 90,000 deaths annually.
Study results from Hollis-Eden’s development program for ARS suggest Neumune may have activity that will protect immune suppressed individuals from hospital-acquired infections through stimulation of innate immunity.
“Pursuing this additional indication creates multiple synergies for our company,” said Richard Hollis, chairman and CEO of Hollis-Eden Pharmaceuticals. “It leverages our progress in our Acute Radiation Syndrome program and expands our opportunities for Neumune into a well-defined mainstream market with a large unmet medical need.”