Fra: "Mary Schweitzer 

9. maj 2004 

Hemispherx Biopharma, the makers of Ampligen, recently read a paper at
the 17th International Conference on Antiviral Research in Tucson, May
3, 2004.  The paper indicates that they have come up with results from
the Phase III trial on Ampligen.  

For those of you not familiar with how
this works, the FDA has stages that a company must go through in
research before approving a drug.  Phase III is perhaps the most
important -- usually double-blind (that means half the patients are just
getting placebo and nobody -- not the doctors, not the patients -- know
which is which), because after Phase III, the drug is still considered
experimental BUT YOU CAN GET IT FROM YOUR DOCTOR.  AND INSURANCE HAS TO
PAY FOR IT (If they would pay for this sort of thing)  And MEDICARE HAS
TO PAY FOR IT.  Also, it can be prescribed off-label -- which insurance
copanies don't usually pay for, but that would be good news for the AIDS
community because I believe that it would help them greatly -- as well
as anyone else who gets the serious forms of HHV-6 (such as Variant A,
which AIDS patients, CFS patients, and patients on immunosuppressant
drugs get).

Now, before you get too excited, I must warn you that from what I know
about the drug approval process it can take the FDA another two years to
actually APPROVE these results -- and it's also possible that what is
statistically significant and works for scholars does not work for the
FDA because Hemispherx may file the forms wrong or not do something they
should have done, or something like that.  The FDA's criteria are
different from that of the scholarly community.  I'm not even sure the
FDA is going to be happy they presented this paper!  Nevertheless, here
is the abstract. It is good news, I think.

I cannot emphasize strongly enough that there are those in the CFS
community who are NOT helped by Ampligen, and as someone who also has
fibro, I can tell you that I don't think Ampligen works much on fibro.
But in my PERSONAL case it has gotten rid of all the M.E.-like symptoms
-- what I sometimes call the encephalitic symptoms like confusion,
aphasia, severe eye and neck pain, lack of balance, loss of memory --
all that stuff.  I think the results would be better if they could use
the 37kDa Rnase-L marker (because it got rid of it for me and for
others), or HHV-6 Variant A, or low natural killer cells -- all markers
that have been shown to be good predictors of who does well on
Ampligen.  They only used the treadmill tests because they would have
had to change the protocol to add the other ones and they did't want to
do that.  (This has taken forever).


------------------------


Phase III.  Randomized, Double-Blinded Clinical Trial in
Chronic Fatigue Syndrome (CFS) Shows significant Improvement in
Exercise Treadmill Duration with Ampligen Compared to Placebo.

William Carter[a], David Strayer[a], William Mitchell[b], Staci
Stevens[c] and
AMP 516 Investigators*; [a]Hemispherx Biopharma, Inc., Philadelphia,
PA; [b]Vanderbilt University, Nashville, TN; [c]Workwell Foundation,
Ripen, CA (USA)

Chronic Fatigue Syndrome (CFS) is a chronic illness characterized by
debilitating fatigue, cognitive dysfunction, immunologic abnormalities,
and viral reactivation.  The CDC estimates that as many as 500,000
persons in the U.S. suffer from CFS.  Yet, CFS is currently only treated
symptomatically as there is no FDA approved therapy.  

Ampligen is a bi-functional, double-stranded(ds) RNA with both antiviral 
and immunomodulatory activities.  

A Phase III, placebo-controlled clinical
trial of Ampligen in CFS enrolled 234 patients at 12 centers in the U.S.
with a 1:1 randomization to either Ampligen (400mg) or placebo twice
weekly for 40 weeks.  Patients were required to have fulfilled the 1988
CDC case definition for at least 12 months.  The primary endpoint was
treadmill exercise duration.  

Patients receiving Ampligen for 40 weeks
improved exercise treadmill performance 19.4% vs. 5.1% in the placebo
group (p< 0.022, analysis of covariance with baseline as covariate).  An
intent to treat analysis included patients who completed less than 40
weeks.  Similar results were obtained with a 17.7% improvement in
exercise treadmill duration in the Ampligen cohort compared to 4.3%
in patients receiving the placebo (p=0.047).  Improvements in exercise
treadmill duration in the patients receiving Ampligen compared to
placebo were greater than twice the minimum considered medically
significant in the protocol (6.5%).  There was no significant difference
(p>0.05) in the number of serious adverse events or dropouts among
patients receiving Ampligen vs. Placebo.  

In conclusion, Ampligen
treatment in a debilitated population of CFS patients resulted in a
medically and statistically significant increase in the primary endpoint,
exercise treadmill duration, compared to placebo.  Ampligen therapy
was generally well-tolerated.

*L. Batemen, J. Bellesorte, P. Cimoch, J. John, R. Keller, C. Lapp, A
Mercandetti, D. Peterson, M. Papernik, R. Podell, B. Stein, and L. Taylor