Hemispherx Releases Recently Manufactured Ampligen for Pancreatic Cancer Early Access Program in the Netherlands to Fill Stoc...
August 28 2018 - 8:30AM
Hemispherx Biopharma, Inc. (NYSE American: HEB)
announced today that the new Ampligen batch manufactured earlier
this year is now released for patients' use in the pancreatic
cancer Early Access Program (EAP) in the Netherlands pursuant to
the terms of our agreement with our EAP provider. This is the
initial shipment (500 vials) of a previously announced 2,100 vial
standing stock order issued by myTomorrows, our EAP provider in
Europe
(https://globenewswire.com/news-release/2016/05/23/842404/0/en/Hemispherx-Amends-and-Restates-Agreement-with-myTomorrows-for-the-Early-Access-Program-for-Rintatolimod-in-Europe.html;
https://www.sec.gov/Archives/edgar/data/946644/000149315218004291/form10-k.htm).
Early Access Programs, also known as Expanded Access Programs,
are market-specific regulatory programs whereby certain governments
allow companies to make a drug available with reimbursement
approved before it is officially commercialized for serious or
life-threatening diseases outside of a clinical trial — if certain
criteria are met — with potential benefits both for patients and
for drug development. These government approved programs allow us
to supply investigational drugs, while obtaining compensation
through reimbursement.
“We have now manufactured approximately 16,000 vials of
Ampligen, with 8,000 vials tested and released for our various
clinical and early access programs and the remaining vials are
expected to be released in the near future. This begins the next
logical step in our short term business plan, where we seek to
obtain reimbursement, at pre-approved rates, for those vials by
supplying early access programs in the United States for ME/CFS and
in the Netherlands for pancreatic cancer, as well as the initiation
of commercial sales from the second lot as a result of our
unrestricted commercial approval for severe ME/CFS in Argentina,”
says Thomas K. Equels, chief executive officer at Hemispherx. “We
will update you on our progress in expanding the U.S. based AMP-511
FDA approved open label program for severe ME/CFS in the near
future as we obtain clear projections on the number of patients who
will benefit from this access, who are enrolled and expected
to be enrolled at the approved clinical sites. We are also working
to expand our ME/CFS U.S. clinical program to unserved regions so
as to allow easier access to the AMP-511 program.”
Hemispherx is an immuno-pharma R&D and an emerging
commercial development company focused on unmet medical needs in
immunology, with a special emphasis in immuno-oncology. Ampligen is
currently used in the Netherlands EAP in the treatment of
pancreatic cancer. In addition, Ampligen is being assessed by
Hemispherx in conjunction with major U.S. cancer research centers
for use in combination with checkpoint blockade therapies in a
variety of solid tumors, including pancreatic cancer.
In clinical trials in a variety of indications, approximately
100,000 doses of our experimental drug Ampligen have been
administered intravenously (IV). We believe this is the most
comprehensive IV safety profile that is generally well-tolerated of
any systemic TLR agonist. Toll-like receptors (TLRs) are a class of
proteins that play a key role in activating the innate immune
system and it is believed that they will play an important role in
future combination therapies in immuno-oncology. A safety profile
of Ampligen administered intranasally also shows it to be generally
well-tolerated based on a Phase I/II vaccine study (Overton ET, et
al. Intranasal seasonal influenza vaccine and a TLR-3 agonist,
rintatolimod, induced cross-reactive IgA antibody formation against
avian H5N1 and H7N9 influenza HA in humans.
Vaccine.2014;32(42):5490-5.doi: 10.1016/j.vaccine.2014.07.078).
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 Number:
800-778-4042 Email: IR@hemispherx.net
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