Hemispherx Biopharma's agreement to supply Ampligen to ME/CFS patients in Europe could not have come at a better time.
A recent paper by a group of downstate New York psychiatrists made headlines when it proposed that fibromyalgia and CFS (among others) should be placed on the spectrum of anxiety disorders.
The agreement to use an immune modifier to treat ME/CFS underscores the position stated in the IOM report that this is not a psychogenic disease, much less an anxiety disorder.
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A recent paper by a group of downstate New York psychiatrists made headlines when it proposed that fibromyalgia and CFS (among others) should be placed on the spectrum of anxiety disorders.
The agreement to use an immune modifier to treat ME/CFS underscores the position stated in the IOM report that this is not a psychogenic disease, much less an anxiety disorder.
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Hemispherx Enters Into an Agreement With myTomorrows for an
Early Access Program for Rintatolimod in Europe
Press Release: PHILADELPHIA, Aug. 10, 2015 (GLOBE NEWSWIRE)
-- Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the "Company" or
"Hemispherx"), reported today that it has executed an agreement with
Impatients, N.V., a Netherlands based company doing business as myTomorrows,
for the commencement and management of an Early Access Program (EAP) in all of
Europe and Turkey.
myTomorrows, as Hemispherx' exclusive service provider in
Europe and Turkey, will perform EAP activities in Europe and Turkey to include
the supply of rintatolimod for the treatment of Chronic Fatigue Syndrome (CFS)
to patients with an unmet medical need.
Govert Shouten, Ph.D, Co-Founder & CBO at myTomorrows,
said "Rintatolimod for CFS fits perfectly with the raison d'être of
myTomorrows. CFS affects as many people in Europe as in the US and there is no
drug approved anywhere specifically for CFS. In clinical trials rintatolimod
has shown promising results for certain CFS patients particularly those most
severely affected.
As we do with other life-threatening and debilitating
diseases such as cancer, MS, and depression, myTomorrows will set up and roll
out the early access programs needed to help these patients.
Thomas K. Equels, Executive Vice Chairman and CFO of
Hemispherx said "We are very pleased to be collaborating with myTomorrows
to provide rintatolimod under these unique Early Access Programs. Not only will
this collaboration create the possibility for physicians to use rintatolimod
under certain circumstances, myTomorrows will collaborate with these physicians
to capture data on patients treated and such data may add to our other efforts
to gain full regulatory approval in Europe, Latin America, Australia, New
Zealand as well as the U.S. and elsewhere."
myTomorrows was founded by physicians and experts from the
pharmaceutical industry who want to facilitate early access to developmental
drugs for patients with high unmet needs. Ronald Brus, M.D., was the former CEO
of Crucell, a vaccine company acquired by Johnson & Johnson for $2.4
billion in 2011. Govert Shouten was previously Vice President, Business
Development at Crucell.
About Rintatolimod
Rintatolimod is a member of a new class of specifically-configured
ribonucleic acid (RNA) compounds targeted as potential treatment of diseases
with immunologic defects and/or viral causation.
About myTomorrows
myTomorrows provides patients that are excluded from
clinical trials access to drugs in development. They focus on disease areas
with unmet needs; oncology, neurology, psychiatry and rare diseases.
myTomorrows identifies the latest developments in drugs and facilitates
requests for access to these drugs in development. Their physicians and bio-medical
specialists identify the latest drug developments from across the globe.
Physicians and pharmacists can register online and request information about
the drugs myTomorrows provides access to. In most countries health authorities
must grant permission for treatment with a non-registered drug. myTomorrows
facilitates requests for permission for physicians and pharmacists.
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 especially
life-threatening viruses. Hemispherx's flagship products include Alferon N
Injection® and the experimental therapeutics rintatolimod and alpha interferon
LDO. Rintatolimod is an experimental RNA nucleic acid being developed for
globally important debilitating diseases and disorders of the immune system,
including Chronic Fatigue Syndrome. Hemispherx's platform technology includes
components for potential treatment of various severely debilitating and life
threatening diseases including cancers.
Disclosure Notice
The information in this press release is intended solely for
the United States and includes certain "forward-looking" statements
including without limitation statements about additional steps which the FDA
may require and Hemispherx may take in continuing to seek commercial approval
of rintatolimod for the treatment of Chronic Fatigue Syndrome in the United
States and abroad. The final results of these and other ongoing activities
could vary materially from Hemispherx's expectations and could adversely affect
the chances for approval of the rintatolimod in the United States and other
countries. Any failure to satisfy the FDA regulatory requirements or the
requirements of other countries could significantly delay, or preclude
outright, approval of rintatolimod in the United States and other countries
including Australia and New Zealand.
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, changes 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 final results of these efforts
could vary materially from Hemispherx's expectations. No evidence has suggested
that rintatolimod will ever be commercially approved for the new potential
treatment indications, including, but not limited, to the treatment of CFS.
Forward-Looking
Statements
To the extent that statements in this press release are not
strictly historical, all such statements are forward-looking, and are made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Words such as "intends," "plans," and
similar expressions are intended to identify forward-looking statements. The
inclusion of forward-looking statements should not be regarded as a
representation by Hemispherx that any of its plans will be achieved. These
forward-looking statements are neither promises nor guarantees of future
performance, and are subject to a variety of risks and uncertainties, many of
which are beyond Hemispherx's control, which could cause actual results to
differ materially from those contemplated in these forward-looking statements.
Examples of such risks and uncertainties include those set forth in the
Disclosure Notice, above, as well as the risks described in Hemispherx's filings
with the Securities and Exchange Commission, including the most recent reports
on Forms 10-K, 10-Q and 8-K. You are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date hereof, and
Hemispherx undertakes no obligation to update or revise the information
contained in this press release, whether as a result of new information, future
events or circumstances or otherwise revise or update this release to reflect
events or circumstances after the date hereof. No evidence is suggested that
rintatolimod will ever be commercially approved for the CFS treatment
indications mentioned in this release into USA or other countries.