The Corpus Callosum

Notice the prominent use of the word “potential.”  That is
potential as in may or may not ever come to anything.  As word
of these potential treatments gets out, we can expect that unscrupulous
persons will try to market things that sound like the potential
treatments I am about to discuss, but which are completely bogus.
 So, I hope that people keep this kind of thing in mind, and
to the extent possible, learn to distinguish fact from fiction when it
comes to health products.   rel="tag">Chronic Fatigue Syndrome is one of those
things that seems to attract a lot of attention from certain kinds of
marketers.

There are two potential products I’m going to mention.  One is
a drug in development by   href="http://en.wikipedia.org/wiki/Ampligen" rel="tag">Ampligen.
 The second is already marketed by href="http://www.roche.com/home.html" rel="tag">Roche
for other purposes, href="http://en.wikipedia.org/wiki/Valganciclovir" rel="tag">valganciclovir
( href="http://www.roche.com/home/service/service-search/service-search-results.htm?qt=Valcyte&x=0&y=0"
rel="tag">Valcyte®),
but not fully tested for use in CFS.


First, about Ampligen.  From the  HEMISPHERx company
website:

Hemispherx Biopharma, based in Philadelphia, is a
biopharmaceutical company engaged in the manufacture and clinical
development of new drug entities for treatment of viral and
immune-based disorders.  Hemispherx’s flagship
products include Alferon N Injection® and the experimental
immunotherapeutics/antivirals Ampligen® and Oragens®…

…Ampligen® (poly I:poly C12U) is a synthetic specifically
configured double-stranded RNA containing regularly occurring regions
of mismatching.  Ampligen® and Oragens®
experimental nucleic acids are being developed for the potential
treatment of globally important viral diseases and disorders of the
immune system including HPV, HIV, Chronic Fatigue Syndrome (CFS),
Hepatitis and influenza.

News from the The
Pink Sheet Daily
, which I can’t really link to, indicates an
anticipated launch for the product in late 2007.  The reason I
can’t link to it is that it is a subscription-only thing.  I
get their emails, and they often include content in the email for one
or two things that are otherwise behind their pay wall.  

Hemispherx Biopharma could launch the first drug for
treatment of chronic fatigue syndrome in late 2007 or early 2008, CEO
William Carter said in an interview with “The Pink Sheet” DAILY. The
company will seek FDA priority review for Ampligen, a double-stranded
RNA treatment; the NDA is on track for filing by year-end, the firm
said Dec. 12.

The filing would culminate more than a decade of research on Ampligen.
The product’s clinical trial program has been slowed because of
difficulty diagnosing patients with the disease, a lengthy one-year
trial that contributed to recruitment challenges and a lack of
knowledge about the disease, according to Hemispherx.

CDC research and work by other agencies has “contributed to remarkable
momentum” behind the understanding of the disease and potential for
treatment intervention in the last six to eight months, Carter said.

“You can reasonably devise from this that there has been a lot of
governmental interest in our work,” Carter said. “We are hopeful this
will lead to an accelerated review.”…

The way that is written, it sounds an awful lot like a press release,
so I don’t wee why anyone should have to pay to read it.  But
business is like that sometimes.

Ampligen
is in Phase III trials
, as posted on the site,
ClinicalTrials.gov.  It is available and in use in other
countries, but not in the USA.  Apparently, the mechanism of
action is not entirely clear, but it does affect the 2-5
Synthetase/RNase L anti-viral pathway.  The drug has been
under development for a long time, and it is not clear at this point
what the delay has been.  There’s an href="http://www.chronicillnet.org/online/Ampligen.html">article
about that on a site, Chronicillnet, but I do not know how reliable it
is.  The href="http://www.chronicillnet.org/calypte/ostrom_bio.html">author
cites some sources for information, but some of it has no citations.
That is not necessarily a criticism; a lot of blog posts are like that.
 It’s just that you need to be careful drawing conclusions
from such articles.

The other drug I wanted to mention is valganciclovir.  There
was an href="http://www.sciencedaily.com/releases/2007/01/070108191506.htm">article
on Science Daily, based upon a press release from Stanford:

…The researchers said they treated 25 patients
during the last three years, 21 of whom responded with significant
improvement that was sustained even after going off the medication at
the end of the treatment regimen, which usually lasts six months. The
first patient has now been off the drug for almost three years and has
had no relapses. A paper describing the first dozen patients Montoya
and Kogelnik treated with the drug was published in the December issue
of Journal of Clinical Virology.

“This study is small and preliminary, but potentially very important,”
said Anthony Komaroff, MD, professor of medicine at Harvard Medical
School, who was not involved in the study. “If a randomized trial
confirmed the value of this therapy for patients like the ones studied
here, it would be an important landmark in the treatment of this
illness.”…

…Valganciclovir is normally used against diseases caused by viruses
in the herpes family, including cytomegalovirus, Epstein-Barr virus and
human herpes virus-6. These diseases usually affect patients whose
immune systems are severely weakened, such as transplant and cancer
patients. Montoya, who had used the drug in treating such patients for
years, decided to try using it on a CFS patient who came to him in
early 2004 with extremely high levels of antibodies for three of the
herpes family viruses in her blood. At the time, she had been suffering
from CFS for five years….

My take on this is that we probably will find out that CFS is actually
a collection of illnesses.  As pharmaceuticals become
available, we will be able to sort patients into different categories,
in part based upon who responds to which drug.  As that is
done, subsequent trials will include more homogeneous patient
populations, which will lead to more reliable findings.
 Progress in medical research sometimes happens like that.

Another comment is this: I am glad to see that some progress is being
made with CFS.  It is one of those conditions in which the
patients initially were maligned, treated with skepticism.  I
am hopeful that there will be less stigma when the illness is better
understood.

Comments

  1. #1 K
    January 17, 2007

    Even recently, patients have been treated badly here in England, you may have read about Sophia Mirza, in brief, she got CFS, she was treated as if it were psychiatric, she was taken against her will to a locked psychiatric ward, her condition got worse, eventually she died in 2005. Some researchers were allowed to look at her spinal cord – they found “unequivocal inflammatory changes affecting the special nerve cell collections (dorsal root ganglia) that are the gateways (or station) for all sensations going to brain through spinal cord. The changes of dorsal root ganglionitis seen in 75% of Sophia‘s spinal cord were very similar to that seen during active infection by herpes viruses (such as shingles).”

    It is an awful story and I hope nothing like that ever happens again.

    As for drugs, I have read that Jonathan Kerr’s team are interested in trialling beta interferon and etanercept.

  2. #2 K
    January 22, 2007

    Hi, I just came back to say, there was a CFS conference in Florida last week, and there’ll be two more conferences in the UK in May

    this one http://www.investinme.org/IIME%20International%20ME%20Conference%202007%20Home.htm

    and this one http://www.meresearch.org.uk/newhorizons.html

    so more info may be published in the relevant journals after they take place, so keep an eye out if you’re interested