[The drug to be tested in Valcyte, which is a potent and highly toxic antiviral from Roche that was approved by the FDA in 2001 for cytomegalovirus retinitis in AIDS patients. Valcyte contains the following black-box warning: “THE CLINICAL TOXICITY OF VALCYTE, WHICH IS METABOLIZED TO GANCICLOVIR, INCLUDES GRANULOCYTOPENIA, ANEMIA AND THROMBOCYTOPENIA. IN ANIMAL STUDIES GANCICLOVIR WAS CARCINOGENIC, TERATOGENIC AND CAUSED ASPERMATOGENESIS.”
In spite of the above, I give this very early CFIDS program a better chance of success than the Ampligen program from HEB that’s in phase-3 because Ampligen has failed in every indication where it’s been tried and I think HEB is a scam. According to item #2 in #msg-15899257, all programs in diseases such as CFIDS should be considered high-risk.]
BOSTON, Jan 15 (Reuters) - Shortly after hiking the Grand Canyon with his wife in 1988, Michael Manson, the co-founder of PetSmart Inc., came down with what felt like the flu. So did business partner Jim Dougherty. The illness changed their lives.
In both men, the flu-like symptoms triggered a more debilitating condition known as chronic fatigue syndrome for which there is no known cure, and no known cause. Its symptoms range from fatigue and vertigo to nausea, pain and cognitive confusion.
Many in the medical community don't believe chronic fatigue syndrome is a real disease. There is no diagnostic test for it. Patients are often referred to psychiatrists on the assumption that their symptoms are psychosomatic.
But for those who suffer its symptoms, including Manson and Dougherty, a former marine who served twice in Vietnam, the condition is all too devastatingly real.
"We've been fighting this for 18 years, and we've tried every possible treatment, from wing of bat to eye of newt," said Manson, who has spent months at a time too weak to walk more than a block or even get out of bed.
Nothing worked - until now. Last June, Manson went to see Dr. Jose Montoya, associate professor of medicine at Stanford University and a specialist in infectious diseases who believes the disorder may be caused -- at least in some cases, by one or more viruses.
Montoya had presented anecdotal data earlier that year at a conference in Barcelona, Spain, which suggested an antiviral drug called Valcyte, made by Swiss drugmaker Roche Holding AG, could be helpful in treating certain CFS patients.
Montoya now has data on 25 CFS patients, nearly all of whom had high levels in their blood plasma of antibodies to the human herpes virus 6 (HHV-6) and the Epstein-Barr virus.
The data -- presented recently at a conference in Fort Lauderdale, Florida -- were remarkably consistent. Nearly every patient responded to the drug, Montoya said, and most of the responses were dramatic.
"Scientists have suspected viruses for years but have never been able to prove it," said Kristin Loomis, executive director of the HHV-6 Foundation, a non-profit group which funds research into HHV-6.
Last year Manson began a six-month course of Valcyte, which is approved to treat transplant patients to prevent viral infection. At first he felt worse. Then, after a few weeks, he began to improve. He started walking, every day a little more.
Now, nearly seven months later, he is walking two or three miles a day and working out with light weights. And he is working on new business ideas.
"Not only is my physical ability returning but my cognitive ability has come back too," Manson said.
Even so, Montoya stresses that the study is extremely small and the results may not be replicated in bigger trials, the first of which he hopes to start within the next few months.
"In a field that has been so stigmatized, and so full of false hopes, I think the patients and the field deserve the best kind of trial, keeping an open mind to the possibility that it won't work," he said.
Roche has agreed to put up $1.5 million to fund the next, 30-patient study. "Whether we put serious money behind this will all depend on the outcome of this next study," said Nigel Pluck, Roche's clinical science leader for Valcyte. "This is a somewhat contentious area for the medical profession in that CFS is not a disease that you can test for. It's a diagnosis that you come to by excluding everything else."
Even if results of further studies are positive they will probably apply only to those patients with active HHV-6 and Epstein-Barr viruses, as indirectly measured by the number of antibodies produced to fight them, Montoya said.
But for those who appear to fit the profile, like Manson, the benefits could be enormous. "We are very excited and holding our breath," he said. <<
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