Press Release From Hemispherx Biopharma on Ampligen's Impact on Chronic Fatigue Syndrome
The following press release was issued today by
Hemispherx Biopharma, Inc.
Hemispherx Biopharma, Inc.
New Government Sponsored Research Points to Gene
Malfunction in Chronic Fatigue Syndrome (CFS)
Malfunction in Chronic Fatigue Syndrome (CFS)
PHILADELPHIA--(BUSINESS WIRE)--July 6, 2005--
Exercise Induced Malfunction in Genes Provides New
Potential Insight into Mechanism of Ampligen(R) Phase
III Clinicals; Exercise Treadmill Improvement as
Primary Efficacy Endpoint
Exercise Induced Malfunction in Genes Provides New
Potential Insight into Mechanism of Ampligen(R) Phase
III Clinicals; Exercise Treadmill Improvement as
Primary Efficacy Endpoint
Hemispherx Biopharma, Inc. (Amex:HEB) announces that
newly published independent studies from Center for
Disease Control (CDC) researchers provide molecular
evidence on the central role of exercise intolerance
in the morbidity of patients suffering from CFS.
Although CFS is associated according to CDC criteria
with some 12 other debilitating clinical
manifestations (fever, myalgia, etc.), the overarching
primary symptom is profound exertional fatigue which
undermines the quality of life. Following on its
recent tradition of intense investigation into medical
and economic sequelae of CFS, the CDC now reports
("Exercise responsive genes measured in peripheral
blood of women with CFS and matched control subjects",
BioMedCentral.com/1472-6793/5/5) that a pool of
metabolism (energy) genes, whose function may be
associated with bodily functions such as muscle
contraction and oxygen consumption, are impaired in
women with CFS on exercise challenge. A matched cohort
of sedentary healthy women did not exhibit a similar
pattern of gene malfunction. Other exercise induced
gene abnormalities were also noted, apparently
involving the immune system.
newly published independent studies from Center for
Disease Control (CDC) researchers provide molecular
evidence on the central role of exercise intolerance
in the morbidity of patients suffering from CFS.
Although CFS is associated according to CDC criteria
with some 12 other debilitating clinical
manifestations (fever, myalgia, etc.), the overarching
primary symptom is profound exertional fatigue which
undermines the quality of life. Following on its
recent tradition of intense investigation into medical
and economic sequelae of CFS, the CDC now reports
("Exercise responsive genes measured in peripheral
blood of women with CFS and matched control subjects",
BioMedCentral.com/1472-6793/5/5) that a pool of
metabolism (energy) genes, whose function may be
associated with bodily functions such as muscle
contraction and oxygen consumption, are impaired in
women with CFS on exercise challenge. A matched cohort
of sedentary healthy women did not exhibit a similar
pattern of gene malfunction. Other exercise induced
gene abnormalities were also noted, apparently
involving the immune system.
Gene abnormalities, such as those described by the CDC
researchers, might be the result of inherited weakness
in energy transfer/metabolism, or - in the alternative
- the gene weakness might be caused by various
environmental factors such as exogenous viruses and/or
noxious agents such as chemical toxins. Further
clinical and molecular research will be needed to
distinguish between these various etiological
possibilities.
researchers, might be the result of inherited weakness
in energy transfer/metabolism, or - in the alternative
- the gene weakness might be caused by various
environmental factors such as exogenous viruses and/or
noxious agents such as chemical toxins. Further
clinical and molecular research will be needed to
distinguish between these various etiological
possibilities.
Exercise treadmill impairment is already a recognized
"end point" to quantify disability in various chronic
diseases, particularly including CFS. Thus, the US
Social Security Administration (SSA) has implemented a
policy of recognizing the functional impairment on
treadmill performance as the basis for partial or
complete disability - thereby qualifying CFS sufferers
for long-term governmental subsidies (partial, or
complete financial support). The average age of onset
of CFS is about 35, coinciding with the peak of
professional achievement and income potential.
"end point" to quantify disability in various chronic
diseases, particularly including CFS. Thus, the US
Social Security Administration (SSA) has implemented a
policy of recognizing the functional impairment on
treadmill performance as the basis for partial or
complete disability - thereby qualifying CFS sufferers
for long-term governmental subsidies (partial, or
complete financial support). The average age of onset
of CFS is about 35, coinciding with the peak of
professional achievement and income potential.
Accordingly, Hemispherx adopted the exercise treadmill
testing as the primary therapeutic (efficacy) endpoint
in its recently completed Phase III Study (active drug
vs. placebo in a one-to-one randomization) of 234
patients evaluated for 64 weeks. By predetermined
regulatory/scientific criteria, the drug arm evidenced
certain medically and statistically significant
changes over the placebo arm. These clinical effects
were recently summarized at the peer reviewed XVIII
International Congress in Barcelona, Spain. Separate
investigations have indicated that double-stranded RNA
drug molecules (of which Ampligen(R) is an example)
may activate a battery of human genes. Thus it appears
that the physical performance changes observed on
treadmill testing might be due in part to changes at
the gene level. While gene modulation studies were
conducted apart from the recently completed Phase III
studies (which relied on clinical endpoints) parallel
in vitro studies on interferon inducers (such as
double-stranded RNAs) have suggested a possible role
in modulating gene activity associated with energy
transport and metabolism.
testing as the primary therapeutic (efficacy) endpoint
in its recently completed Phase III Study (active drug
vs. placebo in a one-to-one randomization) of 234
patients evaluated for 64 weeks. By predetermined
regulatory/scientific criteria, the drug arm evidenced
certain medically and statistically significant
changes over the placebo arm. These clinical effects
were recently summarized at the peer reviewed XVIII
International Congress in Barcelona, Spain. Separate
investigations have indicated that double-stranded RNA
drug molecules (of which Ampligen(R) is an example)
may activate a battery of human genes. Thus it appears
that the physical performance changes observed on
treadmill testing might be due in part to changes at
the gene level. While gene modulation studies were
conducted apart from the recently completed Phase III
studies (which relied on clinical endpoints) parallel
in vitro studies on interferon inducers (such as
double-stranded RNAs) have suggested a possible role
in modulating gene activity associated with energy
transport and metabolism.
About Hemispherx
Hemispherx Biopharma, based in Philadelphia, is a
biopharmaceutical company engaged in the manufacture
and clinical development of new drug entities.
Hemispherx's flagship products include Alferon N(R)
and the experimental antiviral products, Ampligen(R)
and Oragens(TM). These novel Alferon-N proteins,
commercially available for a category of STD
infection, and experimental nucleic acids are being
developed for globally important chronic diseases and
disorders of the immune system including HPV, HIV, CFS
and hepatitis and avian flu. Its four major technology
platforms include large-and small-agent components for
potential treatment of various chronic viral
infections, and are being developed with various
corporate, governmental and academic collaborators
worldwide. Hemispherx has in excess of 150 patents
comprising its core intellectual property estate, a
fully commercialized product (Alferon N(R)) and GMP
certified manufacturing facilities for its novel
pharma products. Presently it is expanding its
facilities to accommodate GMP production of
Ampligen(R). For more information please visit
www.hemispherx.net
biopharmaceutical company engaged in the manufacture
and clinical development of new drug entities.
Hemispherx's flagship products include Alferon N(R)
and the experimental antiviral products, Ampligen(R)
and Oragens(TM). These novel Alferon-N proteins,
commercially available for a category of STD
infection, and experimental nucleic acids are being
developed for globally important chronic diseases and
disorders of the immune system including HPV, HIV, CFS
and hepatitis and avian flu. Its four major technology
platforms include large-and small-agent components for
potential treatment of various chronic viral
infections, and are being developed with various
corporate, governmental and academic collaborators
worldwide. Hemispherx has in excess of 150 patents
comprising its core intellectual property estate, a
fully commercialized product (Alferon N(R)) and GMP
certified manufacturing facilities for its novel
pharma products. Presently it is expanding its
facilities to accommodate GMP production of
Ampligen(R). For more information please visit
www.hemispherx.net
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(R) and Oragens) 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. Only Clinical
Studies under well-controlled conditions can establish
efficacy and safety of any product. Clinical trials
for other potential indications of the approved
biologic Alferon N do not imply that the product will
ever be specifically approved commercially for these
other potential treatment indications.
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(R) and Oragens) 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. Only Clinical
Studies under well-controlled conditions can establish
efficacy and safety of any product. Clinical trials
for other potential indications of the approved
biologic Alferon N do not imply that the product will
ever be specifically approved commercially for these
other potential treatment indications.
1. HIV is a massive scientific fraud. Something akin to a Ponzi scheme. Scientists who challenged the HIV theory of AIDS (the ones who have been thuggishly censored and silenced) turn out to be on the money.
2. Chronic Fatigue Syndrome and Autism (and many other so-called HHV-6 related mysterious epidemics) are part of the so-called AIDS epidemic. Chronic Fatigue Syndrome and Autism both are clearly the results of the ravages of HHV-6.
3. AIDS and Chronic Fatigue Syndrome has been artificially and politically separated into two epidemics. We are living in a period of CFS/AIDS apartheid. So-called AIDS patients have to sit in the back of the HHV-6 epidemic bus while the befuddled HHV-6/CFS patients and HHV-6/Autism victims sit up front. Nobody is well-served.
4. AIDS is not a sexually transmitted disease. That paradigm has set a scapegoating and antigay agenda in place that the public thinks is solidly based on science. It is only based on homophobic and racist nosology, epidemiology and virology. The scientists behind the paradigm are charlatans and crooks.
5. The Centers for Disease Control in Atlanta and the Pasteur Institute in Paris have a great deal in common with the institutions of Nazi medicine. For Blacks, everything these institutions have done in the name of AIDS really constitutes a second Tuskegee Syphilis Experiment.
Elements of a Scientific Ponzi Scheme like the Montagnier-Agut HIV Fraud Ponzi Scheme and HHV-6 Cover-up
A
scientific Ponzi scheme begins with a central seminal or foundational
scientific fraud and is sometimes built on an infrastructure of smaller
scientific frauds. Like the fake dividends issued in a strictly
financial Ponzi scheme, a scientific Ponzi scheme issues fake dividends
in the form of ongoing fraud-based research often framed as
"breakthroughs" and bogus extrapolations which make it look like
everything is above board and that what, in reality, is scientific
fraud, appears to the rest of the scientific community and the public as
good faith progress.
A classic scientific Ponzi scheme like the Montgnier-Agut HIV Fraud Ponzi Scheme and HHV-6 Cover-up include elements like these:
1. Nosological fraud.
2. Epidemiological fraud.
3. Virological fraud.
4. Treatment fraud.
5. Public health policy fraud.
6. Concealment of negative scientific data and paradigm-challenging anomalies.
7. Use of an elite network of "old boys" and pseudo-activist provocateurs to censor critics and whistleblowers.
8. Chronic obscurantism.
9.
If necessary, vigilantism and witch-hunts against any intellectuals,
scientists, or citizens who constitute any form of resistance to the
Ponzi scheme.
10. A subservient scientific press that is used as a conveyor belt for the Ponzi scheme's propaganda.
Everything
always looks like it is working perfectly in a Ponzi scheme, until the
moment comes when someone look at the books and blows the whistle.
Hopefully, that game-changing moment for the Montagnier-Agut HIV Fraud
Ponzi Scheme and HHV-6 Cover-up is coming soon.
