ncidod/diseases
/cfs/), the National Institute of
Health (http://www.
NI Research today announced the release
of the
March issue of NeuroInvestment, reviewing the development of novel
therapies for the treatment
of schizophrenia. The
forthcoming April issue will cover new treatments for spinal cord injury. General
Population
Study were age 49 or younger.
suffers dysautonomia
Podell, a graduate of Harvard Medical School and presently
affiliated with Robert Wood Johnson Medical School and Dr. RESEARCH TRIANGLE PARK, N. Results
of the R. study, called the R.2 percent.E.longtime heck
nih.asp?view=print
About Hemispherx
Hemispherx
Biopharma, based in Philadelphia, is a
biopharmaceutical company engaged in the manufacture and clinical
development of new drug entities. Subsequently, following several years of extensive data
analysis
and further lab tests on selected CFS patients, the FDA, on
May 1, 1997, approved the Company's treatment
protocol, Amp 511, under
its Investigational New Drug #39,250 utilizing Ampligen(R) in the
treatment
of patients with severe CFS, and on March 10, 1998 provided
written authorization for the Company
's pivotal Phase III, double
blind study, Amp 516, utilizing Ampligen(R) in the 64 week treatment
of 234 patients with CFS. To date, with more than 750 CFS patients
having been treated with study
medication (either Ampligen(R) or
placebo), no statistical analysis conducted by the Company and
/or its
independent statistical consultants has revealed a
statistically-significant difference
in serious adverse events between
the two arms of study medication (Ampligen(R) vs. 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. The percentage
of patients who reported having
RLS symptoms at any frequency was 7. Eighty-one percent of these
RLS
sufferers (n=337) reported discussing their symptoms with a primary care
physician yet only
6. "Millions of people suffer
from RLS yet some physicians may not connect certain physical and sensorimotor
symptoms to RLS, resulting in a sizeable population that is not getting
medical attention or diagnosis
. Disturbance of daytime
activities was reported by 55.
The study authors believe that patient
complaints of sleep abnormalities
as well as daytime performance-related effects including difficulty
concentrating should be clues to physicians that a patient may be suffering
from RLS.fibro ager
Chronic Fatigue
Syndrome Presented at Symposium in New York
There is
currently no effective treatment available
in the marketplace.
The forward-looking statements represent the Company's judgment as of
the
date of this release.E.S.S.chronically fms
Both physicians received consultative
fees from the Company for conducting
the clinical investigations and
reporting results at peer reviewed scientific meetings.5 decades
. With state hospitals closed for all but the most
devastatingly afflicted, there is an underclass
of the chronically mentally
ill, most of whom are schizophrenic, who rely upon a fragile safety net
of
community mental health services, group residences, sheltered vocational
settings, and family
support, derailed from the mainstream.
The March issue also reports on developments in the CNS
field, including
the Tysabri situation, the failure of Axonyx's Phenserine Phase III trial,
and
Valeant's purchase of Xcel.cfs mickel
It should
be noted, however, that only regulatory bodies, including the
FDA, are
allowed to make the determination of drug safety; further, the
completion of a Phase
III study should not be construed as predicting
when, if ever, any drug, including Ampligen(R), would
be approved for
any commercial sales. NI has published NeuroInvestment since 1995. NI
Research
also publishes the annual Private CNS Company Review, whose 2005
edition is scheduled for release
in late March; and provides product
licensing consultation and custom research for large and small
pharmaceutical firms.E.
Researchers observed that the RLS sufferers had lower quality of life
scores than the general population and concluded that their quality of life
appears to be comparable
with that experienced by patients with other chronic
medical conditions such as type 2 diabetes and
clinical depression.severely fms
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.PRESS RELEASE Schizophrenia Programs
Reviewed by NeuroInvestment
The current armamentarium offers symptom-control as the best
that
can be hoped for, freeing most of these patients from the invisible
warehousing of state mental hospitals
, but leaving them on the fringe of
society. At present, there is no cure in sight.S.E.S.fms hummingbirds
Hemispherx
has more than 200 patents
comprising its core intellectual property estate, a fully
commercialized
product (Alferon N(R)) and GMP certified manufacturing
facilities for its novel pharma products.
Some propose that it is this cognitive deficit that is primary in
schizophrenia, from which the symptoms
of hallucinations and delusions then
spring, as if they constitute a maladaptive attempt to fill
the ideational
vacuum left by thought disorder and dysfunction.S. and Europe.heck wellman
This was reported in
the CFS
Advisory Committee Report dated January 5, 2005.cdc.htm), The Chronic
Fatigue Syndrome
Advisory Committee
(http://www. For further information on the process of
conduct of clinical
trials and the steps of regulatory review, please
read the relevant sections of the Company's filings
with the
Securities and Exchange Commission. Schizophrenic patients constitute the majority of patients
living
in group homes and supervised apartments, and they account for perhaps
one-third of the
ravaged, homeless denizens of shelters and underpasses in
cities across America. A wide range of
therapeutics under development are assessed,
with an emphasis upon those which may begin to remedy
cognitive symptoms,
including novel glutamatergic, nicotinic, and serotonergic strategies.
NI
Research is the leading publisher of independent research regarding the
CNS therapeutics area.
After obtaining background information from 15,391 study participants,
researchers collected details
from the respondents that reported experiencing
RLS symptoms at any time in the past year, about
the frequency and nature of
their RLS symptoms, the degree of associated distress, and prior physician
consultation and diagnosis.S.hummingbirds chronic
The conference, sponsored by Hemispherx
Biopharma (AMEX:HEB), included
presentations by CFS experts Dr.
Richard N.
CFS is a debilitating disease that affects between
400,000 and
1,000,000 Americans and an equal number of Europeans. CFS
imparts profound deficits
in oxygen consumption on its sufferers,
which impairs their ability to perform functions necessary
to maintain
a basic quality of life. Clinical
trials for other potential indications of the approved
biologic
Alferon N(R) do not imply that the product will ever be specifically
approved commercially
for these other treatment indications.
NeuroInvestment Subscription Rates:
Pharmaceutical:
3-month trial $350, 1 year $1250, 2 years $2280
Individual Investor: 3-month trial $150, 1 year
$450, 2 years $800. For combined
hardcopy and email delivery, add $50 per year
Information
about NeuroInvestment's Institutional Edition is available on
request.C. Another arm of the R.restlesslegs
.chronic doona
Dr.org/cfidslink/oct-cfsac-update. Cognitive symptoms: deficits in attention, memory, and
organizational
skills, are now receiving far more attention that they once
did.T. General Population Study. RLS
encompasses a range of severity that includes mild,
moderate and severe symptoms.com.fatigue foothold
Bateman, who
directs the
Fatigue Consultation Clinic in Salt Lake City, Utah, presented a
comprehensive introduction
and overview of CFS, giving the medical
community an opportunity to get a better sense of the magnitude
of the
disease both in terms of individual suffering and economic costs.net
For several years
, Hemispherx has co-sponsored various scientific
meetings in CFS and provided research grants/contracts
to better
understand the disorder.niaid. A subset of these patients
(2.E.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare
companies.encephalomyelitis chronic
cfids. For more information please
visit www. There is a sea change in terms of research
emphasis, and
NIMH has spotlighted (and funded) the identification of drugs that will
ameliorate
the cognitive symptoms of this disorder -- because even if they
are not the wellspring from which
positive symptoms emerge, they are a
morass that prevent schizophrenic patients, with but rare exceptions
, from
living fully engaged and productive lives.D.hummingbirds chronically
hemispherx.net
About Ampligen(R)
The
Company's work in the development of Ampligen(R), following
its initial licensure from Johns Hopkins
University, has spanned about
1. The
improvement in medication has not changed the proportion
of schizophrenics
who even maintain a steady job, about 10% -- about the same proportion as
eventually
commit suicide.Large Multinational General Population Study Shows That Restless Legs Syndrome is Common
Under-Diagnosed and Can Negatively Impact Sleep and Daily Activities
5 percent of RLS sufferers.encephalomyelitis doona
For
clarification and amplification of previous Company
press releases regarding this extensive development
work, early in the
process, after the Company concluded an FDA approved well controlled
24 week
study of 92 patients with CFS, the FDA, in 1991, placed
Ampligen(R) on clinical "hold" because of
questions and concerns
regarding various potential toxicities, including life-threatening
events
. Some
of the programs included in this review are from Organon, Neuro3D, Cortex
(AMEX: CORACAD
).
Recent issues of NI have reviewed neural cell therapy programs, ALS
therapies and overviewed
the CNS therapeutics sector in general.
Primary Care Study, was published in the May 2004 issue
of the journal Sleep
Medicine, and included epidemiological information on RLS gathered from
patients
and doctors at primary care centers in the U.
"One of the biggest issues facing those with symptoms
of Restless Legs
Syndrome is obtaining appropriate diagnosis and management," said Nancy L.T. Poor
circulation (18.3 percent), arthritis (14.
babs hummingbirds
, The first
multinational study to assess
patients considered to have diagnostic criteria
for Restless Legs Syndrome (RLS), a chronic and disruptive
neurological
disorder characterized by a compelling urge to move the legs, found that the
condition
is common, under-diagnosed, and can significantly impact sleep and
daily activities. 5. While RLS
patients are generally older, of the group defined as RLS
sufferers, 36 percent of the RLS sufferers
in the R.2 percent reported being diagnosed with RLS.myalgic fibro
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
. The first generation of
antipsychotic medications exclusively addressed hallucinations and
delusions
, while exacerbating the negative and cognitive symptoms that were
seen as secondary.
The March
issue of NeuroInvestment summarizes the current treatment
options, and then reviews current major
themes in schizophrenia research;
the contribution of genetic, environmental, and neurostructural
defects to
the disease.7 percent of study participants overall), defined as RLS sufferers,
reported
having symptoms two to three times per week and symptoms that were
moderately or severely distressing
(n=416).3 percent) and back problems (12.foothold dysautonomia
Other sources of information on the disorder
may be accessed
at: the Center for Disease Control and Prevention
(http://www.gov/factsheets/cfs.
Information
contained in this news release other than historical
information, should be considered forward-looking
and is subject to
various risk factors and uncertainties. Schizophrenia is the most
devastating
of all psychiatric illnesses: Just as Alzheimer's lyses memory,
and ALS dissolves the body's musculature
, schizophrenia erodes an
individual's personality and prospects, generally beyond recognition or
retrieval.
Outside the US/Canada add $40 per year for hardcopy airmail.
Of the RLS
sufferers identified in the study that did seek medical
attention (81 percent), 74.7
percent)
were the most common diagnoses reported.myalgic chronically
Dr. According to a report by the Centers for
Disease Control
and Prevention (CDC), CFS is more serious than
multiple sclerosis with respect to medical severity
and the overall
economic affect that it has on society. Prestwick, Avera, Lundbeck,
Saegis, Memory
(NASDAQ: MEMY), Targacept, AGY, Psychiatric Genomics,
DarPharma, Abbott, Vanda, and Alamo Pharmaceuticals
.S.2 percent indicated that they were given a diagnosis of
RLS.
The frequency of any RLS symptoms
in the total study population was
approximately twice as high for women as it was for men (9 percent
vs.longtime suffers
But there is work in progress that could alter that bleak landscape. (RLS Epidemiology, Symptoms
, and
Treatment) General Population Study, a population-based survey completed by
telephone and
face-to-face interviews, are published in the current issue of
the Archives of Internal Medicine
, a peer-reviewed journal of the American
Medical Association.
Earl, M."
In addition to
a compelling urge to move the legs, RLS is characterized by
uncomfortable or sometimes painful sensations
in the legs often described as
creeping-crawling, tingling, pulling or tightening. General Population
Study found that among the subset of
patients defined as RLS sufferers, more than 75 percent of these
patients
reported at least one sleep related symptom. Disrupted sleep,
the inability to fall
asleep and insufficient hours of sleep are common among
RLS sufferers.cfids foothold
Podell summarized the investigational
therapeutic Ampligen(R) Phase
III results for which he was a Principal Investigator.gov. The
fundamental
paradigm regarding the symptoms of schizophrenia is being
altered, and with it, the focus of therapeutic
programs and
experimentation. Prevalence of the condition increased up to age 79 and then
declined
.
RLS Impact on Sleep and Daily Activities
The R.doona heck
Health professional
interested
in learning more about Hemispherx' investigational and
research programs in CFS and allied disorders
may contact the Company
at IR@Hemispherx.
Quality of life was evaluated in this study using
the Short Form - 36
Health Survey (SF36), an extensively tested and validated tool that assesses
eight dimensions of health-related quality of life: physical functioning,
physical limitations
on normal role activities, bodily pain, general health,
energy and vitality, social functioning,
emotional limitations on normal role
activities, and mental health.hummingbirds ager
Lucinda
Bateman from Johns
Hopkins University. Its flagship products include
Alferon N(R) and the experimental antiviral products
, Ampligen(R) and
Oragens(TM). placebo). Any
specifically referenced investigational drugs and
associated
technologies of the company (including Ampligen(R) and Oragens(TM) 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 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 including
Ampligen(R), and this
determination can only be legally made by regulatory bodies.T. Symptoms of
RLS generally
occur at rest, such as when sitting, lying or sleeping, and are temporarily
relieved
by movement.4
percent).E.T.wellman encephalomyelitis
Dr.
T., Group Director Clinical Neurology, GlaxoSmithKline
, the company
that funded the R.T.8 percent recalled receiving a diagnosis for their
symptoms,
but only 6.fms encephalomyelitis
Business Editors/Health/Medical Writers
NEW YORK----Chronic Fatigue Syndrome
(CFS) diagnosis and current potential medical management for the
debilitating disease were highlighted
at a scientific symposium held
recently in New York City. Podell also
participated in earlier
evaluations of the investigational and
experimental treatment of CFS. For more information on Restless
Legs Syndrome, visit http://www.longtime fms
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