Ampligen® May Be an Important Candidate for EBOV Testing in West Africa
PHILADELPHIA, Feb. 12, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx") and the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) will present findings of new studies of Ampligen® (rintatolimod), an experimental therapeutic, performed by USAMRIID scientists in models of Ebola virus infection. The findings will be presented during the 7th Annual International Symposium on Filoviruses – Ebola: West Africa and Recent Developments in Washington, DC, March 25-28, 2015. The conference brings together international experts to deal with various aspects of controlling the ongoing Ebola outbreak in West Africa.
Dr. William A. Carter, Chairman and CEO of Hemispherx Biopharma; Dr. David Strayer, Hemispherx' Medical Director; and Drs. Rekha Panchal and Veronica Soloveva of USAMRIID co-authored the paper to be presented titled "Anti-EBOV Activity/Increased Survival with Rintatolimod, a Specifically Configured dsRNA, to Target Ebola VP35-Induced Disarming of Innate Immune Responses."
Double-stranded RNA (dsRNA) is a common component of viral replication and initiates signaling pathways that normally activate innate immune responses, including interferon (IFN) antiviral cascades. Ebola virus disease induces a relative dsRNA deficiency. The IFN induced antiviral pathways include expression of two enzymes, 2'-5' adenylate synthetase and protein kinase R, which require dsRNA as a co-factor for activation. Rintatolimod (PolyI:PolyC12U), Ampligen®, an experimental therapeutic, was designed to induce IFN, but with a reduced incidence of adverse events (AEs) compared to polyI:polyC, and has demonstrated broad antiviral activity against both DNA and RNA viruses. The hypothesized mechanism of action against EBOV is that VP35 binding of viral dsRNA creates a relative dsRNA deficiency and blocks IFN induction which Ampligen®, a synthetic dsRNA, reverses. The recent results from USAMRIID compel Hemispherx to move forward its experimental therapeutic Ampligen® in the fight against this dread disease plaguing West Africa and to continue to work diligently with the Food and Drug Administration (FDA) and other international organizations committed to the effort to mitigate the ongoing morbidity and mortality of Ebola. Recently, one of the two experimental therapeutics in evaluation in West Africa was withdrawn from clinical studies leaving the experimental product, favipiravir, as an antiviral agent for active clinical trials. Ampligen® also exhibits broad-spectrum antiviral activity against other viruses that are highly pathogenic to humans, including the SARS virus (Day, et al. Virology 2009;395:210-222) and Western Equine Encephalitis Virus (WEEV), where Ampligen® demonstrated a greater than 2 fold survival benefit (mice) compared to favipiravir, a potential Ebola treatment (Julander, et al. Antiviral Res 2009;82(3):169-171).
On February 6, the three Ebola-hit countries have reported 65 more confirmed, probable, or suspected cases and 38 more deaths since the World Health Organization's (WHO's) epidemiologic update on February 4, 2015. The new reports lift the overall totals in the three countries to 22,525 confirmed, probable, and suspected infections and 9,004 deaths.
Hemispherx' Tom Equels states, "Absent an effective therapeutic, this disease is here to stay. Working together, governments, medical scientists and the pharmaceutical industry can win the fight against Ebola."
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. Ebola virus specifically inhibits the dsRNA within cells via a sequestration process. Such RNA would otherwise cause a robust antiviral response to be mounted: Ampligen® may be able to overcome this deficiency in host response. Positive results against Ebola in vitro, and in animal models, have been reported to the Company by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and other research/academic institutions in the US and abroad. Clinical protocol development is being pursued. Clinical trial data will be necessary to establish human efficacy of Ampligen® for Ebola viruses.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities ("biological modifiers") for treatment of seriously debilitating disorders especially life-threatening viruses. 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 including cancers. 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 Injection® 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
The information in this press release includes certain "forward-looking" statements including without limitation statements about additional steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of the Ampligen® NDA for the treatment of Chronic Fatigue Syndrome in the United States. The production of new Alferon® API inventory will not commence until validation phases are complete. While the facility is approved by FDA under the Biological License Application ("BLA") for Alferon®, this status will need to be reaffirmed upon the completion of the facility's enhancements prior to commercial sale of newly produced inventory product. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon® API, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. 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 an Ampligen® NDA in the United States and other countries. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of an Ampligen® NDA in the United States and other countries.
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. 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 could vary materially from Hemispherx's expectations. Findings from animal studies may not correlate with results from humans. Clinical trial data will be necessary to establish human efficacy of Ampligen® or Alferon® for Ebola virus disease.
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, 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 Alferon® N, Alferon® LDO and/or Ampligen will ever be commercially approved for the new potential treatment indications mentioned in this release.