Ampligen® May Be an Important Candidate for EBOV Testing in West Africa
Hemispherx Biopharma, Inc. 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 Recently, one of the two experimental therapeutics in evaluation in West Africa was withdrawn from clinical studies leaving the experimental product, favipiravir, as an antiviral agent for active clinical trials.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.