Hemispherx Biopharma Reports Article by Senior Authors From Italian Ministry of Health and Related Agencies Suggesting Broad Applicability of Ampligen(R) to Multiple Sclerosis

PHILADELPHIA, Sept. 23, 2015 (GLOBE NEWSWIRE) — Hemispherx Biopharma (NYSE MKT:HEB) announced today a new peer reviewed article, with senior authors from the Italian Ministry of Health and other related agencies published in Clinical and Cellular Immunology: J. Clin Cell Immunol, 2015, vol 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 authors note recent studies that suggest an ameliorative role of TLR3 in the onset and progression of MS and experimental autoimmune encephalomyelitis (EAE) in a murine model of MS and observe: “Therefore, TLR3 stimulation with synthetic immuno-modulators could represent a potential alternative approach in MS therapy.” The authors note that many other TLRs, including TLR2 and TLR4, induce production of pro-inflammatory cytokines, thus contributing to CNS damage, whereas up-regulation of TLR3 has been shown to play a beneficial role that is capable of inhibiting the production of harmful cytokines, thereby potentially reducing MS severity. ”The possibility to modulate immune response with specific TLR agonists or antagonists and by inhibiting intracellular proteins involved in the signaling cascade has sparked great interest as alternative approach to treat immunological disorders including MS.” Thus, the authors hypothesize that Ampligen®, an experimental therapeutic, “could represent a safe and effective treatment for MS patients, and could be considered a valuable adjunct to multiple different immunotherapies currently in use or in development.”

The authors, in evaluating the potential activities and mechanism of action of Ampligen® in Chronic Fatigue Syndrome (CFS) elaborate what, in their view, are the many significant overlaps between MS and CFS (Please see Table 1 of their article), including symptomatic similarities, similarities in immune, inflammatory, oxidative and nitrosative pathways as well as similarities in auto immune responses. They note that currently there are at least 8 different products approved by the Food and Drug Administration (FDA) as disease modifying agents (DMA) for MS. They believe that the “most important factor in the future development of MS drugs”… is “additional therapies for halting neuro- degeneration, promoting remyelination and neuronal repair.”  To that end, they specifically suggest Ampligen®, an experimental therapeutic, as a promising “relatively safe and efficacious drug in the treatment of MS, both as monotherapy or as an add-on agent to the first line DMAs.”  The authors note that brain and CNS (central nervous system) symptoms such as mental fatigue, cognitive dysfunction (problems with short term memory, concentration and maintaining attention), disequilibrium, word finding disabilities, headaches and migraines have significant symptomatic similarities between MS and CFS.

They also note that Ampligen®, an experimental therapeutic, can manipulate the immune system as antiviral therapy, as shown by independent researchers demonstrating activity of Ampligen® against flaviviruses, including West Nile virus as well as virus classes associated with bioterrorism.

The authors conclude that “Ampligen® might be considered for use in MS patients with suboptimal responses to IFN beta and who are reluctant or unable to use other approved DMAs.”

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 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 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. 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.

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.

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