Hemispherx Publishes Data on the Bioactivity of Ampligen® in
Chronic Fatigue Syndrome ("CFS")
Peer-Reviewed Data in Two Publications Supports the Pending NDA
Philadelphia, PA, Monday, March 19, 2012: Hemispherx
Biopharma, Inc. (NYSE Amex: HEB) (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® [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,
In the current PLoS One publication, a Phase III, FDA
authorized study in CFS evaluated the safety and therapeutic
effectiveness of Ampligen®, an experimental therapeutic, in
234 subjects with debilitating CFS at 12 clinical sites in
the United States. The Ampligen® treatment was generally
well-tolerated. The article can be found at
The primary endpoint, exercise tolerance, improved an average
of 21% in subjects receiving Ampligen® 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® group versus placebo (p<0.05). an=""
ad="" hoc="" continuous=""
responder="" analysis="" of=""
between="" 25%="" and=""
50%="" at="" 5%=""
greater="" response="" for=""
ampligen®="" compared="" to=""
The Ampligen® 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=""
study="" which="" emphasizes=""
economic="" burden="" of=""
medical="" care="" for=""
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®.
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
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.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty
pharmaceutical company engaged in the manufacture and
clinical development of new drug entities for treatment of
seriously debilitating disorders. Hemispherx's flagship
products include Alferon N Injection® (FDA approved for a
category of sexually transmitted diseases) and the
experimental therapeutics Ampligen® and Alferon® LDO.
Ampligen® is an experimental RNA nucleic acid being developed
for globally important debilitating diseases and disorders of
the immune system. Hemispherx's platform technology includes
components for potential treatment of various severely
debilitating and life threatening diseases. Hemispherx has
patents comprising its core intellectual property estate and
a fully commercialized product (Alferon N Injection®). The
Company wholly owns and exclusively operates a GMP certified
manufacturing facility in the United States for commercial
products. For more information please visit
Information contained in this news release, other than
historical information, should be considered forward-looking
and is subject to various risk factors and uncertainties. For
instance, the strategies and operations of Hemispherx involve
risk of competition, changing market conditions, change in
laws and regulations affecting these industries and numerous
other factors discussed in this release and in the Company's
filings with the Securities and Exchange Commission. Any
specifically referenced investigational drugs and associated
technologies of the Company (including Ampligen® and Alferon®
LDO) are experimental in nature and as such are not
designated safe and effective by a regulatory authority for
general use and are legally available only through clinical
trials with the referenced disorders. The forward-looking
statements represent the Company's judgment as of the date of
this release. The Company disclaims, however, any intent or
obligation to update these forward-looking statements. The
planning, completion, results or submission of clinical
trials do not imply that any study product will ever be
approved commercially for the studied or other treatment
This press release was issued by Hemispherx Biopharma Inc. and was initially posted at http://www.hemispherx.net/content/investor/default.asp?goto=729 . It was distributed, unedited and unaltered, by noodls on 2012-03-19 14:17:19 PM. The issuer is solely responsible for the accuracy of the information contained therein.