Hollis-Eden submits proposal for Acute Radiation Syndrome therapy

By E. Janene Geiss

Philadelphia, Feb. 24 - Hollis-Eden Pharmaceuticals, Inc. announced Friday that it has submitted its formal proposal in response to the Department of Health and Human Services solicitation DHHS-ORDC-DDA-05-12 for "Medical Countermeasures To Mitigate Or Treat Neutropenia Alone Or In Combination With Co-Morbidities Associated With Acute Radiation Syndrome (ARS)."

Hollis-Eden said it responded to the request for proposal with the goal of securing an advance purchase contract for its ARS drug candidate, Neumune, under Project BioShield, according to a company news release.

As conveyed in its proposal, Hollis-Eden said it has met or exceeded the mandatory criteria for eligibility as set forth by the department in the proposal request.

The criteria include that the proposed medical countermeasure must mitigate or treat the neutropenia component of ARS when administered after exposure to 2 to 6 Gy irradiation, as evidenced by an increase in the overall survivability from ARS, and that the offering company must have an active Investigational New Drug application filed with the Food and Drug Administration for studies to support the indication of mitigating or treating the neutropenia component of ARS and have completed a phase 1 clinical trial in humans to evaluate the safety of the compound.

Beyond these criteria, Hollis-Eden said it believes Neumune offers a number of distinct advantages that could deliver additional value to the government and its citizens and therefore merit additional consideration.

In addition to mitigating neutropenia (loss of infection fighting white blood cells), Neumune has consistently demonstrated in animals exposed to a range of sublethal and lethal levels of radiation the ability to mitigate other potentially life-threatening components of ARS, including thrombocytopenia (loss of platelets necessary for blood clotting) and anemia (loss of red blood cells), officials said.

Neumune also has increased survival in large numbers of rhesus monkeys exposed to high-dose radiation, even in the absence of critical supportive care such as platelet transfusions and antibiotics, officials said.

In phase 1 studies with healthy human volunteers, Neumune has generated statistically significant increases in neutrophils and platelets that were comparable in magnitude to the increases in neutrophils and platelets seen in unirradiated monkeys, officials said. These results suggest that benefits seen in irradiated monkeys should translate to irradiated humans.

In phase 1 human studies, Neumune has shown an attractive safety profile to date, and Neumune is cost-effective, officials said.

The company said Neumune is stable at room temperature and is not expected to require refrigeration for storage.

Hollis-Eden said it believes Neumune may offer the first practical medical countermeasure that can be forward-deployed and self-administered in major cities across the United States in the event of a nuclear incident.

"Given the gravity of the nuclear threat to our nation, it is a privilege to respond to this initial step by the Department of Health and Human Services to procure medical countermeasures for ARS," Richard B. Hollis, chairman and chief executive officer of Hollis-Eden, said in the release.

"With the increasing geopolitical concerns about the proliferation of nuclear weapons and the stated goal of terrorist organizations to use such weapons on American soil, we believe it is imperative that the government do everything in its power to prepare the nation for such an event," he added.

Hollis-Eden is a San Diego development-stage pharmaceutical company working to become a leader in the development of a new class of investigational drugs known as immune regulating hormones.

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