Hemispherx to Distribute Second Lot of Ampligen® for use in Multiple Indications in Argentina, the United States and Europe
18 September 2018 - 10:30PM
Hemispherx Biopharma, Inc. (NYSE American:
HEB) announced today regulatory inspection and clearance
for distribution of the Company’s second commercial scale lot of
Ampligen® (rintatolimod), which is slated for multiple uses
including product launch in Argentina, where Ampligen is approved
for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue
Syndrome (ME/CFS), ME/CFS expanded access program (EAP) in the
United States and Europe and an EAP in the Netherlands for
pancreatic cancer. This lot includes approximately 8,000 vials and
is the second such lot filled and finished this year, giving a
usable Ampligen supply of approximately 16,000 vials.
Ampligen, a first-in-class drug of large macromolecular RNA
(ribonucleic acid) molecules, was approved for commercial sale in
Argentina in 2016 for the treatment of ME/CFS, the first therapy
ever approved for this quality-of-life impacting disease. The
Argentine commercial launch is scheduled for year end and the first
quarter of 2019. The Company will also provide Ampligen to medical
centers in the U.S. and Europe for use in EAPs for patients with
ME/CFS and in the Netherlands for pancreatic cancer. Finally, but
significantly, the Company expects to commence additional clinical
trials using Ampligen in combination with FDA-approved checkpoint
blockade therapies in an effort to improve overall efficacy and
survival in cancers such as pancreatic, non-small cell lung,
ovarian and colorectal tumors, the first of which may commence
within sixty days.
According to the Centers for Disease Control and Prevention,
ME/CFS is a serious, long-term illness that affects many body
systems. People with ME/CFS are often not able to do their usual
activities. At times, ME/CFS may confine them to bed. People with
ME/CFS have severe fatigue and sleep problems. ME/CFS may get worse
after people with the illness try to do as much as they want or
need to do. This symptom is known as post-exertional malaise (PEM).
Other symptoms can include problems with thinking and
concentrating, pain, and dizziness. According to an Institute of
Medicine (IOM) report published in 2015, an estimated 836,000 to
2.5 million Americans suffer from ME/CFS, but most of them have not
been diagnosed.
“We are pleased to announce completion of our second commercial
size lot of Ampligen and excited about the opportunities
availability of the therapy affords us. From a product launch in
Argentina, to supporting patients through EAPs and in evaluation
for the treatment of solid tumors, we are working to advance
Ampligen as rapidly as possible, and realize its potential across
multiple market opportunities,” said Thomas K. Equels, Chief
Executive Officer of Hemispherx. “While there are millions of
ME/CFS patients across the globe, the approval of Ampligen in
Argentina represents the first therapy ever approved for treatment
of the condition. Additionally, we are hopeful that our initial
trials in solid tumor indications will demonstrate the promise of
the therapy in combination with checkpoint inhibitors and have a
true impact on the cancer treatment paradigm.”
Hemispherx is working to evaluate Ampligen in several cancers,
and the current supply of newly filled and finished Ampligen will
support the initiation of a Phase I/II study in combination with
checkpoint inhibitors in the treatment of solid tumors. The Company
is working closely with the internationally acclaimed cancer
research centers at Roswell Park, University of Nebraska, and
University of Pittsburg to launch these important programs. These
planned and imminent clinical trials are based upon pre-clinical
animal experiments in which potentially significant combinational
synergies were observed. Proof of concept clinical trials have also
been conducted in humans to confirm the changes Ampligen creates in
the micro-environment of many solid tumors, which are a potential
key to improving checkpoint blockade therapy efficacy.
The planned oncology clinical programs follow the recent
publication (Cancer Res May 31 2018 DOI:
10.1158/0008-5472.CAN-17-3985) of a head-to-head study in explant
culture models that pitted Ampligen against two other TLR3 agonists
to measure how each individually might enhance the tumor
microenvironment for checkpoint blockade therapy. All three TLR3
agonists activated the TLR3 pathway and promoted an accumulation of
killer T cells, but only Ampligen did so without causing attraction
of immune suppressive elements, such as regulator T cells. This is
a potentially important advantage Ampligen may have over other TLR3
agonists. Additionally, Ampligen is the only TLR3 agonist
with an extensive safety profile showing it to be generally well
tolerated in humans. Almost 100,000 doses of intravenous Ampligen
have been administered in clinical settings.
About Hemispherx Biopharma Hemispherx
Biopharma, Inc. is an immuno-pharma R&D and emerging commercial
growth company focused on unmet medical needs in immunology.
Hemispherx’s flagship products include Alferon N Injection® and the
experimental therapeutic rintatolimod (tradenames Ampligen® or
Rintamod®). Rintatolimod is an experimental RNA nucleic acid being
developed for globally important debilitating diseases and
disorders of the immune system, including immuno-oncology and
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).
Hemispherx’s platform technology includes components for potential
treatment of various severely debilitating and life-threatening
diseases. Because rintatolimod is experimental in nature, it is not
designated safe and effective by the FDA for general use and is
legally available only through clinical trials.
Cautionary StatementSome 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. 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.
ContactHemispherx Biopharma, Inc. Phone:
800-778-4042 Email: IR@hemispherx.net
Or
LHA Investor RelationsMiriam Weber MillerPhone:
212-838-3777Emil: mmiller@lhai.com
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