Hemispherx Links Stanford’s ME/CFS Diagnostic to a Potential Path Forward for Ampligen Commercialization
06 Mayo 2019 - 7:30AM
Hemispherx Biopharma Inc., (NYSE American: HEB), an immuno-pharma
company focused on the research and development of therapeutics to
treat multiple types of cancers and immune-deficiency diseases —
and whose product portfolio includes Ampligen, commercially
approved in Argentina, as the world’s only approved therapeutic for
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) —
announced today that the impressive results from a blood-based,
real-time diagnostic test out of Stanford University demonstrates
an ability to identify moderate to severe ME/CFS patients from
normal controls. Currently ME/CFS is a disease of exclusion from
other diseases, which manifest similar signs and symptoms with no
specific ME/CFS laboratory diagnostic assay to aid the physician in
a definitive diagnosis.
While Hemispherx is currently focused on Ampligen in the
treatment of cancer, for which there are multiple ongoing trials,
regulatory approval of Ampligen in the treatment of ME/CFS in the
United States is also a corporate goal. Profound fatigue is a
universal symptom of severe ME/CFS and its quantitative
documentation is a challenge. A functional ME/CFS diagnostic may
remove this obstacle. Using blood samples from twenty patients with
ME/CFS versus twenty normal controls, Stanford researchers were
able to identify which samples came from people with ME/CFS by
measuring the electrical impedance of the patient’s immune cells
and plasma when osmotically stressed through exposure to high salt
concentrations. The research was recently published in the
Proceedings of the National Academy of Sciences:
https://www.pnas.org/content/early/2019/04/24/1901274116
“This is a potentially landmark study on two fronts,” said
Thomas K. Equels, CEO of Hemispherx. “First, ME/CFS has been
thought of by many as a psychological disorder without a physical
basis, leaving ME/CFS sufferers with the pain of the disease and a
sense of hopelessness. This diagnostic creates a new paradigm of
hope for therapy for those with the disease. Second, a validated
blood-based method to diagnose ME/CFS would have a profound impact
on how it is studied and treated by clearly identifying whether a
subject has the disease. We look forward to the day when we can
incorporate such a diagnostic platform into our own clinical
testing for ME/CFS. We have the only late-stage drug candidate in
the FDA pipeline and have been asked to do a confirmatory clinical
trial. If properly validated with larger numbers of subjects, a
blood-based diagnostic for ME/CFS should help in achieving
regulatory approval.”
In the United States, Hemispherx sponsors an Expanded Access
Program (EAP), known as AMP-511, in which the FDA has authorized
use of Ampligen in ME/CFS patients in an effort to expand
compassionate care in the absence of commercially approved
therapy.
Stanford’s Ron Davis, PhD, professor of biochemistry and of
genetics and one of the study’s authors, emphasized the importance
of a reliable diagnostic platform for ME/CFS in a statement
accompanying the journal article, stating “…there is scientific
evidence that this disease is not a fabrication of a patient’s
mind. We clearly see a difference in the way healthy and chronic
fatigue syndrome immune cells process stress.”
Read the full statement:
https://med.stanford.edu/news/all-news/2019/04/biomarker-for-chronic-fatigue-syndrome-identified.html.
About Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
(ME/CFS)
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a
debilitating disease that lacks a universally accepted case
definition, cause, diagnosis, or treatment. Patients with ME/CFS
suffer from pain and lethargy, and in the severest cases the
disease can take them from their workplaces and their families,
leaving them bedridden. ME/CFS strikes people of all ages and
racial, ethnic, and socioeconomic groups, and is diagnosed two to
four times more often in women.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an immuno-pharma company focused
on the research and development of therapeutics to treat multiple
types of cancers. Hemispherx's flagship products include the
Argentina-approved drug rintatolimod (trade names Ampligen® or
Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on
results of published, peer-reviewed pre-clinical studies and
clinical trials, Hemispherx believes that Ampligen® may have
broad-spectrum anti-viral and anti-cancer properties. Clinical
trials of Ampligen® already conducted include studies of the
potential treatment of cancer patients with renal cell carcinoma
and malignant melanoma. These and other potential uses will require
additional clinical trials to generate the safety and effectiveness
data necessary to support regulatory approval and additional
funding. Rintatolimod is a double-stranded RNA being developed for
globally important debilitating diseases and disorders of the
immune system.
Cautionary Statement
Some of the statements included in this press release may be
forward-looking statements that involve a number of risks and
uncertainties. Among other things, for those statements, we claim
the protection of the safe harbor for forward-looking statements
contained in the Private Securities Litigation Reform Act of 1995.
Any forward-looking statements set forth in this press release
speak only as of the date of this press release. We do not
undertake to update any of these forward-looking statements to
reflect events or circumstances that occur after the date hereof.
The Stanford diagnostic test is at an early developmental stage and
may never be approved as a diagnostic test for ME/CFS. This press
release and prior releases are available at www.hemispherx.net. The
information found on our website is not incorporated by reference
into this press release and is included for reference purposes
only.
Contacts:
Hemispherx Biopharma, Inc.Phone: 800-778-4042Email:
IR@hemispherx.net
Or
LHA Investor RelationsMiriam Weber MillerSenior Vice
PresidentPhone: +1-212-838-3777Email: mmiller@lhai.com
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