Hollis-Eden, a small biotech company in San Diego, is developing a new class of drugs derived from a master hormone that helps run the immune system.
The first of these is called HE2000. A university study in Thailand shows it can help cure malaria. There is good reason to think it could also treat HIV illness, but we may never know because unlike an antiviral, there is no laboratory test that can be used to show the FDA that the drug is effective.
The FDA will license an antiviral drug that reduces HIV levels evidenced by viral load tests. There are other candidate therapies that may effectively fight HIV but there are no laboratory tests that can show us that they work. This means the only test that can be used is seeing whether the medicine keeps people from getting sick and dying--very difficult to show in the era of effective antiviral therapies. HE2000 is one example of such a potential therapy.
How HE2000 Works
One of the chemicals the body makes that acts like an army general giving orders to the immune system is a master hormone called DHEA. It is well known that DHEA is converted by our bodies into testosterone and estrogen and also a long list of hormones that have been shown to have a regulating effect on the immune system.
We also know that as people get older or if they have HIV illness, they have less and less of these hormones. The body fights diseases better if it has enough of these immune regulating hormones. Unfortunately, if we give DHEA to people, it seems to have lots of side effects and the body does not absorb it well.
Hollis-Eden decided to make versions of these hormones that the body can absorb with fewer side effects. HE2000 is the first of these. And Hollis-Eden has found an inexpensive way to produce many versions of this important hormone and to get them into people easily using a "buccal tablet" delivery system, like chewing gum soaked with the hormone that people keep under their tongue for a few minutes.
HE2000 Cures Malaria, Improves Vitality
The US Army is excited about Hollis-Eden’s products because it appears from a small study in Thailand, reported on November 12th in the 50th American Society of Tropical Medicine and Hygiene, Atlanta, Georgia, that Hollis-Eden’s product HE2000 cleared malaria in 17 out of 21 patients tested.
It’s important to note, HE2000 is not a drug that fights malaria. It got the immune system focused on getting rid of the parasites that cause malaria.
And because Hollis-Eden’s products are immune system regulators, they may impact many diseases. In fact, in a study of mice and aging, it is readily apparent which mice got medicine from Hollis-Eden -- they are the young-looking ones who are the same age as the ones whose fur is falling out.
HE2000 and HIV
Logically, a medicine that can positively affect the immune system and make it better able to fight illnesses would be of value in a disease like HIV. After all, HIV cripples the immune system’s ability to fight diseases. If HIV did not do this, it would not be considered an illness - just another virus that does not cause illness like others that the body has under control.
There is some evidence that these Hollis-Eden products might in fact help in HIV illness. In 1999, an important experiment was done on monkeys infected with a close relative of HIV, called SHIV229, a very lethal virus. The monkeys who got HE2000 lived a lot longer, even though the drug did not have an effect on CD 4+ cells or the viral load.
Another study done on human patients in South Africa show many important immune markers associated with inflammation, like TNF-Alpha, IL-6 and IL-8, were all significantly decreased. HE2000 might benefit people with HIV by calming down the immune system, allowing it to fight diseases, including HIV, much more effectively.
Why Has HE2000 Not Been Tested As Medicine for HIV?
There is no way to find out if a product like HE2000 impacts HIV except in long clinical trials to see if it delays people getting sick or dying. But these trials are very expensive and Hollis-Eden cannot afford them.
Hollis-Eden is deciding whether or not to try out HE2000 in HIV illness. It is much easier for them to develop the product for malaria as the military is interested in preventing and treating malaria.
If we want to see this drug tested for its use in HIV illness, then the NIH will have to help. In fact HE2000 is now on the list of new drugs the ACTG is considering sponsoring for new trials.
Given how cheaply HE2000 can be made, and how desperate the world is for an affordable HIV treatment, the sooner the better.
David Scondras is the founder and chairman of Search For A Cure_. Scondras developed the nationally recognized HIV treatment series,_ Reasons for Hope_. All articles in the series are reviewed by expert HIV doctors and scientists and an HIV positive and negative focus group to ensure both accuracy and understandability._
This article was reviewed by Dr. Alfred DeMaria, Jr., Assistant Commissioner of Communicable Disease, Massachusetts Department of Public Health.