For a few years, he and his fledgling company struggled to understand the hormones and how they work in the body. In keeping
with his quest to conquer global infections, Hollis targeted the research at HIV, tuberculosis, and malaria. (The Eden half
of Hollis-Eden is not a silent partner, but the promise of a world with no disease.) In 1998, Hollis hired Chris Reading,
a cellular immunologist, to sort through the company's science program and come up with a plan.
Coming Soon: More Host Therapeutics
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Around that time, the world-health community began pressuring the industry for free AIDS drugs, and compulsory licensing threatened
global profits for companies making and developing AIDS medicines. Hollis decided that, financially, AIDS was not an ideal
first target. But he also was convinced that long term, anti-retrovirals, which focus on killing the pathogen and are subject
to resistance, were not the best answer. He kept his company and its research focused on host therapeutics, medicines that
strengthen the body's immune system in its fight against disease. Then 9/11 happened, and the company shifted its first-to-market
strategy to respond to the new demand for anti-bioterrorism products.
Breaking Ground
The path to market for drugs that will be used to combat bioterrorist attacks is unique. Since scientists obviously cannot
expose large groups of humans to deadly levels of radiation to prove that their drug will keep them alive, they must rely
on animal models to prove efficacy. The approval of the BioShield legislation in mid- 2004, which allocated $5.6 billion and
allowed an expedited process for anti-bioterrorism products, was a boon to Neumune's development. Hollis-Eden marked some
impressive milestones in the last eight months.
Dwight Stickney, vice president of medical affairs and practicing radiation oncologist, leads Hollis-Eden's development of
Neumune, for acute radiation sickness.
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"We were able to demonstrate survivability in non-human primates against lethal doses of radiation," Hollis says. "That was
a very big issue for us, because FDA wanted us to have a clear endpoint. Since we were using the 'animal rule' they didn't
want a surrogate marker, because we were already using a surrogate model. So we had to develop a model to demonstrate that
we could show survivability as an end point in lethal doses of radiation. That's never been done before."
The company tested Neumune in 40 Rhesus monkeys, with another 40 as a control group. The 40 animals that received the drug
were given one of three doses, with the highest doses showing the highest level of efficacy—90 percent survival. In a meta
analysis of all lethal studies reported to date, the mortality rate in the control group was 32.5 percent vs. only 12.5 percent
in the treated animals. In these initial lethal (and in previous non-lethal) studies, Neumune therapy also provided statistically
significant improvement in the recovery of neutrophils, platelets, and red blood cells—all essential in preventing radiation
sickness.
Dwight Stickney, Hollis-Eden's vice president of medical affairs, explains: "We have two models. The first looks at the kinetics
of the bone marrow and the repopulation of these cells that are effective in clotting and infection. We used that model without
intending to do any lethality. After we optimized what we felt was a good formulation and a good dosage, we then developed
the lethal model at the request of FDA. We did several experiments and proved that Neumune was quite effective without any
medical supportive therapy. We went from forty-five percent of the animals dying to ten percent of the animals dying."
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