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Hemispherx Biopharma, Inc.
(the "Company" or "Hemispherx"), announced that on May 13,
2014, the United States Patent Office issued U.S. Patent 8,722,874 titled
"Double-Stranded Ribonucleic Acids with Rugged Physiochemical Structure and
Highly Specific Biologic Activity" to inventors Carter, et al. and assignee
Hemispherx Biopharma, Inc. The patent claims a novel form of rugged dsRNA.
Rugged dsRNA are nucleic acids with a unique composition and physical
characteristic identified with high specificity of binding to Toll-Like
Receptor 3 (TLR3), thereby conveying an important range of therapeutic
opportunities. The newly discovered form of dsRNA has increased bioactivity
and binding affinity to the TLR 3 receptor because of its reduced tendency to
form branched dsRNA, which can inhibit receptor binding. Pharmaceutical
formulations containing the newly discovered nucleic acid as active
ingredients, and methods of treatment with those formulations, are also
described in the issued patent.
The original U.S. composition-of-matter patent on Ampligen® was issued to
Johns Hopkins University in the early 1970's, published in the Journal of
Molecular Biology, and thereafter licensed to Hemispherx Biopharma, Inc.
exclusively. Upon expiration of the original patent, Hemispherx relied on a
continued research program and sizable portfolio of subsequently issued
patents to maintain a degree of proprietary protection for novel compositions
and treatment methods based on Ampligen® technology. The issuance of U.S.
Patent 8,722,874 will help ensure that Hemispherx Biopharma retains patent
protection for novel formulations of Ampligen® products until at least
2029. The current Ampligen® formulations, as a mixture of RNA of different
sizes and variable binding affinities to cell receptors affords a unique array
of potential disease fighting properties through antiviral and
immunomodulatory mechanisms. The newly issued patent discusses how dsRNAs
acting thru TLR3 receptor activation are potent antiviral compounds and
anticancer agents and through secondary immunomodulators that can enhance the
bioactivity of vaccines and treat autoimmune diseases.
The recent Hemispherx effort was started by isolating and characterizing novel
specific molecular species of dsRNA which convey remarkable bioactivity
previously attributed to a broad class of molecules and mixtures thereof. The
Hemispherx inventors discovered, using highly sophisticated analytical
methods, that a highly specific set of molecules discovered based on Ampligen®
technology is responsible for a disproportionately higher percentage of one or
more aspects of Ampligen®'s desirable biological activity.
The significant extension of proprietary longevity via the new
composition-of-matter patent may favorably affect patent longevity of
Ampligen® in approximately 20-25 countries.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company
engaged in the manufacture and clinical development of new drug entities for
treatment of seriously debilitating disorders. Hemispherx's flagship products
include Alferon N Injection® and the experimental therapeutics Ampligen® and
Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed
for globally important debilitating diseases and disorders of the immune
system, including Chronic Fatigue Syndrome. Hemispherx's platform technology
includes components for potential treatment of various severely debilitating
and life threatening diseases. Because both Ampligen® and Alferon® LDO are
experimental in nature, they are not designated safe and effective by a
regulatory authority for general use and are legally available only through
clinical trials. Hemispherx has patents comprising its core intellectual
property estate and a fully commercialized product (Alferon N Injection®),
approved for sale in the U.S. and Argentina. The Company's Alferon® N approval
in Argentina includes the use of Alferon N Injection® (under the brand name
"Naturaferon") for use in any patients who fail or become intolerant to
recombinant interferon, including patients with chronic active hepatitis C
infection. The Company wholly owns and exclusively operates a GMP certified
manufacturing facility in the United States for commercial products. For more
information please visit www.hemispherx.net.
Forward-Looking Statements
To the extent that statements in this press release are not strictly
historical, all such statements are forward-looking, and are made pursuant to
the safe harbor provisions of the Private Securities Litigation Reform Act of
1995. Words such as "intends," "plans," and similar expressions are intended
to identify forward-looking statements. The inclusion of forward-looking
statements should not be regarded as a representation by Hemispherx that any
of its plans will be achieved. These forward-looking statements are neither
promises nor guarantees of future performance, and are subject to a variety of
risks and uncertainties, many of which are beyond Hemispherx's control, which
could cause actual results to differ materially from those contemplated in
these forward-looking statements. Examples of such risks and uncertainties
include those set forth in the Disclosure Notice, below, as well as the risks
described in Hemispherx's filings with the Securities and Exchange Commission,
including the most recent reports on Forms 10-K, 10-Q and 8-K. You are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date hereof, and Hemispherx undertakes no
obligation to update or revise the information contained in this press
release, whether as a result of new information, future events or
circumstances or otherwise revise or update this release to reflect events or
circumstances after the date hereof.
Disclosure Notice
The information in this press release includes certain "forward-looking"
statements including without limitation statements about additional steps
which the FDA and other regulatory agencies may require and Hemispherx may
take in continuing to seek commercial approval of the Ampligen® in the United
States, Europe, South America, or any other countries. The novel patent does
not in any way guarantee the ability to manufacture or supply Ampligen® to
various markets due to the potential for delays in approvals or the inability
to manufacture Ampligen®.The final results of these and other ongoing
activities could vary materially from Hemispherx's expectations and could
adversely affect the chances for approval of the Ampligen® in any of these
countries. Any failure to satisfy these regulatory agencies requirements or
the requirements of other countries could significantly delay, or preclude
outright, approval of Ampligen® in the United States and other countries. For
instance, the strategies and operations of Hemispherx involve risk of
competition, changing market conditions, changes in laws and regulations
affecting these industries and numerous other factors discussed in this
release and in the Company's filings with the Securities and Exchange
Commission. The final results of these efforts and/or any other activities
could vary materially from Hemispherx's expectations.
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