Two Reno scientists, who last year discovered a new infectious human retrovirus they linked to Chronic Fatigue Syndrome, said Monday that their findings have been replicated and confirmed by the U.S. Food and Drug Administration.
Dr. Judy Mikovits, one of the lead researchers with the Whittemore Peterson Institute for Neuro-Immune Disease in Reno, said the FDA’s review of their findings is scheduled to be published in September.
“There has been an issue over whether anybody could replicate our study, and it will not only confirm our findings but extend our findings, which is really exciting for us,” she said.
Mikovits said they also have new, unpublished data concerning the retrovirus, XMRV, that could lead to treatment of Chronic Fatigue Syndrome.
“We have immune system profiles and we can tell by the immune system how the XMRV is doing the damage,” she said. “So we could have a diagnostic test to follow clinical treatment and show that people’s immune systems go back to normal. That’s the latest data that’s really amazing. That’s what we’re after.”
That data will be published by the end of the year, probably in a clinical immunology journal, she said.
Lombardi said clinical trials could begin soon at the Whittemore Peterson Institute, which is relocating from its tiny laboratory on the University of Nevada, Reno campus to the university’s newly opened Center for Molecular Medicine.
“Actually, we already have been contacted by people who are sending us tests, perceiving that they may be asked to be part of the clinical trials,” he said.
“I think once the (FDA) paper comes out and once the controversy is put to rest, the pharmaceutical companies will realize that this is some very low-hanging fruit for them to make the next transition,” said Lombardi. “There are so many drugs that have been developed for HIV, and it’s a retrovirus. So there’s probably a ton of HIV drugs that they can go back and re-screen that could be used.”
There also are three published drugs that work against XMRV, Mikovits said.
“We totally expect at least one clinical treatment trial before the end of the year,” she said. “That is our goal and that’s what this new facility is for.”