Hollis-Eden may receive response from HHS on possible Neumune order before end of June

By Jennifer Lanning Drey

Eugene, Ore., June 19 - Hollis-Eden Pharmaceuticals, Inc. may have a response before the end of the month from the Department of Health and Human Services (HHS) regarding the company's proposal to provide the agency with Neumune (HE2100), according to Robert Marsella, senior vice president of Hollis-Eden.

Neumune is being tested for treatment of acute radiation syndrome, a condition that typically causes the death of people exposed to high doses of radiation, Marsella said Monday at the Rodman & Renshaw 3rd Annual Security, Biodefense & Connectivity Investor Conference.

The drug has been shown to improve survival following exposure to 200 centigray to 600 centigray of radiation and is being considered by the government for use following a nuclear attack, Marsella said.

The Department of HHS said it would respond to proposals for treating acute radiation syndrome in the June timeframe, Marsella said.

The agency has said its initial order would be for 100,000 treatment courses, required to be available within two years, he said.

Hollis-Eden also plans to respond to a request for proposal from the Department of Defense for a separate order, which the agency has said it will issue before the end of the year, according to Marsella.

"An order of any size from either entity will provide key validation for other potential customers - state and local governments, foreign governments, as well as private citizens," Marsella said.

Hollis-Eden has received hundreds of letters from state legislators and private citizens asking about stockpiling Neumune, following a recent segment on CBS' "60 Minutes" that mentioned the drug, Marsella said.

"We are currently the leading drug for acute radiation syndrome," he said.

Neumune is being developed under a Food and Drug Administration animal rule that says Hollis-Eden must prove efficacy in a relevant animal species, such as a monkey, and safety in man.

Hollis-Eden has generated survival data from monkeys that were exposed to 600 centigray of radiation and treated with Neumune but received no other clinical support, which would likely be the case in a nuclear attack, Marsella said.

Through December 2005, Hollis-Eden has treated 111 patients with Neumune. The drug was well tolerated and the only adverse event reported was swelling at the injection site, Marsella said.

Hollis-Eden believes the results found in unirradiated monkeys and humans to date indicate that the benefits observed in irradiated monkeys would translate to humans with exposure to radiation, Marsella said.

"The strategies are in place right now for generating near-term revenues and providing sustainable growth for the company," he said.

Clinical testing in other indications

Hollis-Eden has also filed an Investigational New Drug application for a follow-up indication of Neumune as a treatment for patients at risk of healthcare-associated infections, Marsella said.

This year, the company will initiate phase 1/2 safety studies in at-risk hospital patients, he said.

Hollis-Eden has demonstrated that Neumune has activity in animal models infected with three strains of bacteria that cause healthcare-associated infections, he said.

"The key to fighting hospital infections is the immune system," Marsella said.

Neumune boosts neutrophils and platelets, which are elements of innate immunity, he 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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