In early April, in the Netherlands, Hollis-Eden began its first Phase I safety and pharmacokinetic study of the drug in humans.
Information from the study will be used to match the concentration in human plasma with that needed for efficacy in non-human
primates for the final efficacy study. The company expects to file an investigational new drug application by mid 2005 and
submit a new drug application in 2006. It also began manufacturing scale-up activities and is prepared to start shipping commercial
quantities under the Emergency Use Authorization regulation by mid 2005.
Acute radiation is just the first of many indications that Hollis-Eden plans to pursue. The money earned from the US government's
purchase of Neumune stockpiles will fund a host of other studies for other indications and pipeline projects. "We have lots
of indications and opportunities," Hollis says. "Investors are buying into autoimmune disorders and infectious diseases. And
the chemotherapy market is huge for us."
How can one group of compounds do it all? By targeting the signaling pathways of the immune system, improving endocrine and
dendritic cell production, and stimulating immune response. "In HIV and cancer, the dendritic cells almost disappear," Redding
says. "If you can restore those dendritic cells, we believe that is the reason we are able to improve cell-mediated immunity
or the ability to fight HIV. We can begin to do the same thing in cancer."
Other companies are in competition to bring new autoimmune drugs to the market, but Hollis-Eden believes its compounds will
be significantly more effective because they decrease inflammation and increase overall immunity without leading to immunosuppression.
The current corticosteroids on the market that are widely used in autoimmune disorders often lead to immune suppression and
bone loss. And TNF alpha drugs, which shut down one part of the inflammation response, can cause serious side effects. Hollis-Eden's
compounds stimulate immunity instead of suppressing it, and have the ability to stimulate bone growth instead of leading to
Last year, Hollis-Eden acquired Congressional Pharmaceutical Corp. (CPC), along with the rights to a series of compounds that
have the potential to protect against DNA mutations from radiation exposure or chemotherapy. The lead candidate in the group
is Phosphonol, which the company hopes will also be developed in collaboration with the US government and given an expedited
FDA review as an anti-bioterrorism product.
Also in development is Immunitin [HE2000], another immune-regulating hormone, which has shown in Phase II trials in Africa
that it can reduce opportunistic infections in late-stage AIDS patients. The product has also shown potential in combating
tuberculosis and malaria, and Hollis-Eden is in active talks with governments and nonprofit healthcare organizations around
the world about collaborating on commercialization. The company also recently entered into collaboration with the Cystic Fibrosis
(CF) Foundation to test the drug against CF.
Summing up the company's research and hopes for the future, Hollis says, "We are finding out that HIV and cancer and aging
have many similarities. At the bottom of all three, there is disregulation and inflammation of the immune system. If these
hormones can re-regulate them back to homeostasis and allow the body to respond like it did when it was in a healthy state,
we may have a big breakthrough here in medicine."