Hollis-Eden files IND for phase 1 trials with Neumune in patients at risk of hospital-acquired infections

By E. Janene Geiss

Philadelphia, May 3 - Hollis-Eden Pharmaceuticals, Inc. announced Wednesday that it has filed an Investigational New Drug application with the Food and Drug Administration to begin phase 1 clinical trials with Neumune (HE2100) in patients at high risk of developing hospital-acquired infections.

The purpose of these initial trials will be to establish the safety of Neumune in this population and help identify the optimal patient subsets for further study in phase 2 efficacy trials, according to a company news release.

Neumune is already the subject of an open IND for use in treating Acute Radiation Syndrome, a condition that can increase an individual's susceptibility to life-threatening infections and risk of bleeding, officials said.

Of the 34 million patients admitted to U.S. hospitals and health care facilities each year, about 2 million contract hospital-acquired infections, leading to an estimated 90,000 deaths annually.

Many hospital infections can no longer be cured with commonly used antibiotics. It is estimated that 60% of today's staphylococcus infections are multi-drug resistant strains, officials said.

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.

In the company's ARS program, Neumune has been evaluated in studies in healthy and radiation-induced immune suppressed rhesus monkeys and in phase 1 clinical studies in healthy human subjects, officials said.

Results from these studies indicate that Neumune treatment stimulates formation of bone marrow precursor cells that in turn lead to an increase in neutrophils and platelets. In irradiated monkeys, this stimulation of innate immunity translated into increased survival compared to placebo-treated monkeys in a model where clinical support was not provided, as well as decreased episodes of fever and antibiotic use in a model where clinical support was provided, officials said.

Hollis-Eden is a San Diego biopharmaceutical company developing a proprietary new class of small molecule compounds that are metabolic conversion products or synthetic analogs of adrenal steroid hormones.

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