yesterday. A summary of the study should be available Tuesday
afternoon March 20 on the Research1st site.
http://www.research1st.com/ or watch the CFIDS Association Facebook
page.
March 19, 2012, 8:30 a.m. EDT
Hemispherx Publishes Data on the Bioactivity of Ampligen(R) in Chronic
Fatigue Syndrome ("CFS")
Peer-Reviewed Data in Two Publications Supports the Pending NDA Application
PHILADELPHIA, Mar 19, 2012 (GlobeNewswire via COMTEX) -- Hemispherx
Biopharma, Inc. HEB +18.34% (the "Company" or "Hemispherx") announced
the publication of a peer-reviewed article providing the results from
the AMP-516 Phase III Clinical Trial of Ampligen(R) [rintatolimod,
Poly (I) * (C12,U)], an experimental therapeutic, in the high impact,
online journal, PLoS ONE. The report is entitled "A Double-Blind,
Placebo-Controlled, Randomized, Clinical Trial of the TLR-3 Agonist
Rintatolimod in Severe Cases of Chronic Fatigue Syndrome". Recently,
researchers from the Centers for Disease Control and Prevention
("CDC") and Harvard School of Public Health published new data showing
the profound economic impact of CFS on increasing healthcare costs of
$452 million and decreasing CFS patient productivity by $1.2 billion
in Georgia, a state with approximately 5.5 million people age 18-59
(Cost Effectiveness and Resource Allocation, 9:1, 2011).
In the current PLoS One publication, a Phase III, FDA authorized study
in CFS evaluated the safety and therapeutic effectiveness of
Ampligen(R), an experimental therapeutic, in 234 subjects with
debilitating CFS at 12 clinical sites in the United States. The
Ampligen(R) treatment was generally well-tolerated. The article can be
found at http://dx.plos.org/10.1371/journal.pone.0031334 .
The primary endpoint, exercise tolerance, improved an average of 21%
in subjects receiving Ampligen(R) compared to placebo and the
proportions of patients with exercise improvements of at least 25% and
50% were 1.7 and 1.9-fold greater for the Ampligen(R) group versus
placebo (p<0.05). An ad hoc continuous responder analysis of exercise
improvement between 25% and 50% at 5% increments demonstrated a
significantly greater response for patients receiving Ampligen(R)
compared to placebo.
The Ampligen(R) cohort also reduced dependence on medications used to
reduce symptoms of CFS compared to the placebo group (p<0.05), adding
additional insight to the recent CDC/Harvard study which emphasizes
the overwhelming economic burden of medical care for CFS sufferers.
In 2010, Hemispherx published new data showing that a greater
proportion of placebo patients in this Phase III trial were found to
have a significant prolongation of the EKG QT interval compared to
patients who received Ampligen(R). Prolongation of the QT interval,
which is a risk factor for sudden cardiac death and arrhythmias, was
associated with continued use of certain drugs by CFS sufferers known
to prolong the QT interval (Journal of Applied Research, 10:3, 2010).
CFS patients are considered to be at increased risk for catastrophic
cardiac events despite their relatively young age and the
preponderance of women (approximately 2-3 women for each man) who
suffer from this chronically debilitating disease.
On January 11, 2012, Hemispherx announced that the FDA had granted an
extension of its pending New Drug Application ("NDA") for potential
treatment of CFS. The Company is currently conducting "open-label"
treatment protocol in the U.S. and evaluating new diagnostic
modalities to provide additional insights into the CFS disorder.
The FDA originally concluded (Complete Response Letter received
11/25/09) that this Phase III study was inadequate to support approval
of the NDA. However, the new analyses and other insights in the PLoS
One report supplement the original study findings. The Company
believes that continued efforts to understand existing data and to
advance the development of new data and information, will ultimately
support a re-filing of the NDA.
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