Hemispherx Opens FDA-Approved Reimbursement Based Expanded Access Treatment Program for ME/CFS to New Enrollees at Approved C...
June 27 2018 - 8:30AM
Hemispherx Biopharma, Inc. (NYSE American:HEB) has announced the
immediate expansion of its Treatment Protocol/Expanded Access
Programs for ME/CFS in the United States, known as AMP-511, to new
enrollees for the first time in more than a year. This opportunity
to expand the scope of AMP-511 is based on the successful
completion of the first phase of its Ampligen manufacturing
initiative producing sufficient quantities of Ampligen to support
new enrollees in this FDA-approved program. Additional enrollees
will be added as supplies of Ampligen expand with the successful
fill and finish of additional commercial-sized lots similar to the
8,500 vials just released for human use. However, due to the nature
of the limitations in such FDA-approved programs, the number of
enrollees will always be limited.
The two approved sites are the Hunter-Hopkins Center in
Charlotte, North Carolina and Sierra Internal Medicine in Incline
Village, Nevada.
Charles W. Lapp, MD, Principal Investigator at Hunter-Hopkins
Center stated “Hunter-Hopkins Center is delighted to hear that the
compassionate care program for Ampligen/rintatolimod will once
again be welcoming new subjects.”
Daniel Peterson, MD, Principal Investigator at Sierra Internal
Medicine stated “We are very enthusiastic about the recent
communication from Hemispherx Biopharma announcing the immediate
compassionate care protocol expansion.”
Hemispherx announced on June 3, 2018, that its first commercial
sized lot of Ampligen, consisting of 8,500 vials, had passed all
required testing for regulatory release for human use. “We view the
compassionate care program as just a band aid for a much larger
problem. We estimate over one hundred thousand people are now
fully disabled in the United States due to ME/CFS. This
incapacitating unmet medical need should be aggressively addressed
by providing therapeutic options, just as the FDA did when it
successfully addressed the AIDS crisis years ago,” said Thomas K.
Equels, Chief Executive Officer of Hemispherx. “This successfully
released batch of Ampligen will be utilized to expand our ME/CFS
compassionate care programs in Nevada and North Carolina and our
expanded Early Access Program in Europe in pancreatic cancer, as
well as for important immuno-oncology clinical studies in the
United States. These studies will include Phase I/II studies of
Ampligen in combination with checkpoint blockade drugs in a variety
of solid tumor cancers.”
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 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 believe that Ampligen® may have
broad-spectrum anti-viral and anti-cancer properties. Clinical
trials of Ampligen® already conducted by Hemispherx include studies
of the potential treatment of cancer patients with renal cell
carcinoma and malignant melanoma, CFS, Hepatitis B and HIV. All of
these potential uses will require additional clinical trials to
generate the safety and effectiveness data necessary to support
regulatory approval. Rintatolimod is a double-stranded RNA being
developed for globally important debilitating diseases and
disorders of the immune system. Commercialization of Ampligen® in
Argentina will require, among other things, an appropriate
reimbursement level, appropriate marketing strategies, completion
of manufacturing preparations for launch (including possible
requirements for approval of final manufacturing) and we most
likely will need additional funds to manufacture product at a
sufficient level for a commercial launch.
Cautionary StatementSome of the statements
included in this press release may be forward-looking statements
that involve a number of risks and uncertainties. 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 Phone Number:
800-778-4042 Email: IR@hemispherx.net
Photos accompanying this announcement are available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/d9606b9f-1b2f-4b86-8ffb-3a15856f05a9
http://www.globenewswire.com/NewsRoom/AttachmentNg/850c72b8-d828-4059-ba42-94b755604963
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