Hemispherx Files Positive Safety Report on Intranasal Use of Ampligen in Combination with FluMist Influenza Vaccine
July 09 2018 - 8:30AM
Hemispherx Biopharma, Inc. (NYSE American:HEB)
announced the filing of a clinical study report on AMP-600, a Phase
I/II trial of intranasal Ampligen® in combination with FluMist®
influenza vaccine with the U.S. Food and Drug Administration.
Hemispherx is a research and development and, consistent with its
commercial and early access program approvals, an emerging
commercial development company focused on unmet medical needs in
immunology, with a special emphasis in immuno-oncology.
The two-stage randomized, double-blinded, placebo-controlled,
clinical trial assessed the immunogenicity and safety of intranasal
FluMist administered sequentially with intranasal Ampligen. The
report indicates that there was no evidence of any increase in
adverse effects related to higher dosage levels of Ampligen or to
the continued administration of Ampligen during the second and
third dual vaccinations. The intranasal use of Ampligen and FluMist
was generally well-tolerated and generated antibodies against
influenza subtypes not present in the seasonal vaccine.
In February 2018, the U.S. Centers for Disease Control and
Prevention Advisory Committee on Immunization Practices voted in
favor of renewing its recommendation for the use of FluMist
Quadrivalent vaccine for the prevention of influenza during the
2018-2019 flu season.
Pre-clinical studies of Ampligen in combination with seasonal
influenza vaccines indicate the intranasal combination could be
highly effective in vivo against both seasonal and avian influenza
A viruses (H5N1) and 3 H5N1 clades. H5N1 is proven to be
highly lethal in humans and has the mutagenic potential for
pandemic transmission. In both preclinical and clinical studies,
the intranasal combination of seasonal vaccine and Ampligen was
observed to generate cross reactive antibodies, which could extend
or preserve vaccine efficacy as viruses mutate.
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. 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
Hemispherx Biopharma (AMEX:HEB)
Historical Stock Chart
From Aug 2024 to Sep 2024
Hemispherx Biopharma (AMEX:HEB)
Historical Stock Chart
From Sep 2023 to Sep 2024