PHILADELPHIA, Sept. 28, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the “Company” or “Hemispherx”), announced that it received formal notice on September 21, 2015, that the European Patent Office’s Examining Division granted the Company’s application titled “Double-Stranded Ribonucleic Acids with Rugged Physiochemical Structure and Highly Specific Biologic Activity” by 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. This 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 this nucleic acid as active ingredients, and methods of treatment with those formulations, are also described in the granted patent.
Hemispherx’s President, Thomas K. Equels, stated, “We are pleased to announce this significant step in our business plan for Ampligen. Success at this critical stage is important for implementation of our global program for Ampligen and, while formal approval by the member nations is still pending, this formal notification by the EPO of the granting of the composition of matter patent is an essential step in that approval process.”
With this important milestone achieved, the patent will enter a national validation phase taking several months that may include review and approval by up to approximately 25 countries. A similar application (U.S. patent 8,722,874) was granted in the U.S. on May 13, 2014.
An earlier U.S. composition-of-matter patent on Ampligen®, an experimental biotherapeutic, was issued to Johns Hopkins University with results 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 related patents to maintain a degree of proprietary protection for novel compositions and treatment methods based on Ampligen® technology. With issuance of U.S. Patent 8,722,874, and this significant progress with the EPO, Hemispherx’s planned patent protection for novel formulations of Ampligen® products may extend through 2029 and potentially beyond.
Patent extension is a possibility in the U.S. because of patent law provisions (commonly known as the “Hatch-Waxman Amendments”), which permit patent extensions in certain cases to partially compensate for patent life lost due to a lengthy clinical drug development cycle. Hemispherx is presently engaged in multiple clinical trials in the U.S. related to Chronic Fatigue Syndrome (CFS) (AMP-511), enhancement of immune responses to influenza vaccines, and various immunotherapies for human cancers. Similar clinical studies are projected for the European Union and Australia under various collaborative agreements.
Hemispherx has identified an immune marker, low NK cell activity, which is associated with increased CFS symptom severity and responds favorably to Ampligen® treatment in vitro. On September 15, 2015, Hemispherx announced the publication of a peer reviewed article in the Journal of Clinical and Cellular Immunology (Strayer D, et al, 2015;6:4 http://doi.org/10.4172/2155-9899.1000348) entitled “Low NK Cell Activity in Chronic Fatigue Syndrome (CFS) and Relationship to Symptom Severity” in which 17 studies were reviewed that evaluated NK cell cytotoxicity (NKCC) data and the relationship to different CFS case definitions and CFS disease severity. NK cells are an important component of the human immune response acting as a surveillance mechanism against invading pathogens and tumor cells. The review includes evidence that there is an association between decreased NK cell activity and increased CFS symptomatology. New data were reported in this publication, of in vitro exposure of peripheral blood mononuclear cells (PBMCs) from 15 CFS patients. These data indicated than in vitro exposure to Ampligen®, an experimental biotherapeutic, produced a 178% increase in mean NK activity (NKCC) and a 100% increase in median NK activity (NKCC).
For cancers that were previously, largely untreatable, Hemispherx also has identified potential therapeutic regimens that combine Ampligen with newly proven immunotherapeutics with the goal of increasing overall effectiveness and survival. These new immunotherapeutics are also called “check-point inhibitors” because they unleash the human immune apparatus to accelerate the killing of human tumor cells.
On September 23, 2015, Hemispherx announced another new peer-reviewed article with senior authors from the Italian Ministry of Health and other related agencies published in Clinical and Cellular Immunology: 2015;6:4 entitled, “A Toll-Like Receptor 3 – Agonist as Promising Candidate in Multiple Sclerosis Treatment.” As stated in the Abstract of the article by the Italian authors: “The aim of this paper is to provide a brief overview of Ampligen® historical development, clinical pharmacology, clinical trials, and safety data and to discuss about its potential role in MS treatment in the context of existing treatment options.” In the article, the authors observe that Ampligen®, an experimental therapeutic, unlike all other toll-like receptors (TLRs) studied to date, has a unique immune mechanism making it potentially adaptable as a treatment for many different disorders including multiple sclerosis (MS). They further state: “another winning point of TLR-targeting drugs is that they have fewer side effects and lower or no toxicity compared to other drugs used in MS treatment.”
The recently issued U.S. patent, and its counterpart in the EU, indicate how dsRNAs acting through TLR3 receptor activation may prove to be potent antiviral compounds and anticancer agents and, through secondary immunomodulators, have the potential to enhance the bioactivity of vaccines and treat autoimmune diseases.
The significant extension of proprietary longevity via the new composition-of-matter patent in the U.S. and the application now accepted by the EU is expected to favorably affect patent longevity of Ampligen® in potentially up to an additional 25 countries.
About Ampligen®
Ampligen®, an experimental therapeutic, is a new class of specifically-configured ribonucleic acid (RNA) compounds targeted as potential treatment of diseases with immunologic defects and/or viral causation.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the 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 FDA approval of Alferon N Injection® is limited to the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. 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
Disclosure Notice
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties including, but not limited to, general industry conditions and competition; general economic factors; the Company’s ability to adequately fund its projects; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Company’s ability to accurately predict the future market conditions; manufacturing difficulties or delays; dependence on the effectiveness of the Company’s patents and other protections for products; and the exposure to litigation, including patent litigation, and/or regulatory actions; as well as numerous other factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. The FDA approval of Alferon N Injection® is limited to the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. The final results of these efforts and/or any other activities could vary materially from Hemispherx’s expectations. For instance, any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of Ampligen® in the United States and other countries. The re-launch of Alferon N as a commercial product cannot commence until all regulatory approvals have been obtained.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, are based upon the current beliefs and expectations of the Company’s management, are subject to significant risks and uncertainties and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “intends”, “plans”, “potential”, “potentially”, “possible” 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, above, 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. No evidence is suggested that Ampligen® will ever be commercially approved for the new potential treatment indications mentioned in this release.
CONTACT: Company/Investor Contact: Charles Jones CJones & Associates Public Relations 888-557-6480 cjones@cjonespr.com
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