Hemispherx Biopharma Inc. Announces Advancement in Expanded Access Program for Ampligen in the Treatment of Myalgic Encephalo...
January 02 2019 - 8:30AM
Hemispherx Biopharma, Inc. (NYSE American: HEB), an immuno-pharma
R&D and emerging commercial growth company focused on unmet
medical needs in immunology, shipped 325 recently manufactured
vials of Ampligen to the Myalgic Encephalomyelitis/Chronic Fatigue
Syndrome (ME/CFS) clinical site at Incline Village, Nevada, run by
Daniel Peterson, MD. This clinic is at the forefront of ME/CFS
research and treatment. The vials will be used in the Expanded
Access Program (“EAP”) known as “AMP-511”. The FDA authorized the
AMP-511 protocol to treat ME/CFS patients in an effort to expand
compassionate care in the fight against this quality-of-life
impacting disease where there is no commercially approved therapy.
Hemispherx recently announced the expansion of the protocol. New
enrollees will not be eligible to participate in a future
confirmatory trial. A plan for a future pivotal confirmatory trial
is in development, but previously-treated patients will not be
eligible for participation. This renders the EAP an increasingly
important tool for patients who benefited from Ampligen based on
their inclusion in previous trials.
Hemispherx manufactures Ampligen, and it is the Company’s
control over the production of the product that allows for use of
the product in this EAP. In 2018, the Company produced two
large lots, totaling approximately 16,000 vials, replenishing
Ampligen supplies.
“More than 100,000 Americans are fully disabled by severe
ME/CFS. This is a horrible disease and a totally unmet medical need
in the United States. ME/CFS in its most severe form takes people
from the workforce and from their family life, leaving them in a
bedridden state,” said CEO Thomas K. Equels. “Ampligen is the first
and only meaningful therapy approved anywhere in the world for
ME/CFS, with our recent approval in Argentina. It is also the only
ME/CFS drug with a late stage new drug application at the U.S. Food
and Drug Administration. This progress in expanding AMP-511, as we
ended the year, is also a message of hope. While we have made
great advances in our immuno-oncology programs, we want those
suffering from ME/CFS to know that TeamHemispherx will never give
up in the fight for therapeutic options in ME/CFS.”
Daniel Peterson, MD, a world-renowned expert in the treatment of
ME/CFS with Ampligen and principal investigator at the Incline
Village Nevada clinic states, “Rintatolimod, or Ampligen, is a
useful drug for a subset of severely ill ME/CFS patients to improve
quality of life and functional status. In some cases, the response
can be so dramatic that patients return to gainful employment
and/or school following treatment. Rintatolimod has an excellent
safety profile. In addition, there are measurable outcomes to
assess the drug’s efficacy, which should be investigated.”
About AmpligenThe FDA authorizedexpanded access
program will allow treatment of up to 100 ME/CFS patients at any
one time at approved clinical infusion therapy sites. Ampligen has
received approval from Administracion Nacional de Medicamentos,
Alimentos y Tecnologia Medica (“ANMAT”) for commercial sale of
Ampligen in the Argentine Republic for the treatment of severe
ME/CFS. Details of the commercial launch are in the final stages in
Argentina. Further, Ampligen has completed a U.S. based Phase III
study for the treatment of ME/CFS, and the Company is in the final
stages of identifying a subset of high level Ampligen responders
for consideration by the FDA in a confirmatory trial to help
complete our pending New Drug Application with the FDA. The first
steps for initiating our European EAP in ME/CFS are now underway.
In oncology, Ampligen is an experimental drug currently undergoing
clinical Phase I/II development for the treatment of certain
cancers at major U.S. cancer research centers based on successful
animal studies. Further, the Dutch government has approved an EAP
for late stage pancreatic cancer patients, which has been underway
with full reimbursement for over one year.
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.
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
Hemispherx Biopharma (AMEX:HEB)
Historical Stock Chart
From Mar 2024 to Apr 2024
Hemispherx Biopharma (AMEX:HEB)
Historical Stock Chart
From Apr 2023 to Apr 2024