Hemispherx’s Ampligen Highlighted in Review of Role of TLR3 Agonist Support for “Universal” Flu Immunization Development Programs

Three Studies Reviewed at Keystone Symposium on Emerging Technologies in Vaccine Discovery and Development Demonstrate Production of Antibodies Against Highly Pathogenic Strains of Avian Flu Viruses with Human Pandemic Potential with Seasonal Vaccines

BANFF, Alberta, Jan. 31, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American:HEB) said William Mitchell, MD, PhD*, Professor of Pathology, Microbiology & Immunology at Vanderbilt University, provided the first composite review of previously published studies of the potential role of Ampligen® (rintatolimod) in creating broader viral coverage of seasonal vaccines. 

The first of the studies was in rodents, next in non-human primates (monkeys), and the third in healthy human subjects.  The impetus for the three peer-reviewed research programs originated with Hideki Hasegawa, MD, PhD, Director Department of Pathology at Japan’s National Institute of Infectious Diseases, which sponsored the rodent and monkey studies. Commenting recently, Dr. Hasegawa said in response to this review, “Our experimental findings in rodents and non-human primates using intranasal vaccination clearly showed that Ampligen enhanced the activity of influenza vaccines by conferring increased cross-reactivity and cross-protection, even with deadly avian H5N1 influenza viruses.  Such effects will be key to the development of a universal vaccine for influenza.”

The positive rodent and monkey findings led to a human study at the University of Alabama, sponsored by Hemispherx. The Principal Investigator of this Phase 1/2 trial of 12 healthy volunteers was Edgar Turner Overton, MD. Dr. Overton stated regarding this review,  “Building on the work of Dr. Hasegawa, we studied intranasal Ampligen administration following influenza vaccine clinically.  The Ampligen was well-tolerated and evidence for cross-reactivity against avian influenza strains was also seen in humans.” The study found that the combination of intranasal FluMist® followed by intranasal Ampligen produced specific secretory IgA antibody responses of at least 4-fold over baseline against at least one of the homologous vaccine strains in the vaccine in 92 percent of the subjects.  Moreover, the experimental vaccination strategy induced cross-reactive secretory IgA antibodies against highly pathogenic avian influenza strains H5N1, H7N9, and H7N3, all with pandemic potential for humans. The researchers reported that the combination of Ampligen and FluMist was well-tolerated. 

Professor Mitchell from Banff stated, “The current poor protection afforded by this season’s flu vaccines, ~10% in Australia and ~30% in North America, provides greater incentive for a ‘universal’ vaccine providing high protection for multiple years against the yearly minor changes referred to as antigenic drift as well as major changes from influenza viruses prevalent in animal reservoirs that have acquired easy infectivity in humans (antigenic shift).The data from the Japanese National Institute of Infectious Diseases and the University of Alabama reviewed today clearly demonstrate that the elements of a universal vaccine may be achievable through simply administered nasal immunization of seasonal vaccines in combination with a TLR3 agonist (Ampligen/ rintatolimod) to achieve immune enhancement by ‘epitope spreading’. The data demonstrated in animals and humans show the generation of antibodies against highly pathogenic avian influenza viruses with high lethality in humans, ~60% for H5N1 and ~40% for H7N9, with super pandemic potential if the ability to easily infect humans through antigenic shift is obtained with retention of high lethality. Data from the Banff meeting suggest technical pathways to achieve maximum responses for the original observations reported by Dr. Hasegawa.”

David R. Strayer, MD, chief scientific and medical officer of Hemispherx, noted that, “proven technology exists to create and make vaccines to protect against the specific strain of flu virus predicted to be the most prevalent for the coming season.  However, the source of seasonal vaccine ineffectiveness rests in the lengthy manufacturing lead time and the potential of the selected strain to mutate, rendering the vaccine less effective or not effective at all. The quest is for a ‘universal’ vaccine that can protect against all major known classes of the virus, a goal which may be achieved only by introducing, through an agent like Ampligen, elements of cross reactivity and cross protection.  After decades of research to develop a safe and effective universal flu vaccine, the goal is still unfulfilled. Ampligen may with additional testing be a relatively quick way to provide a safe and effective approach against the debilitating, costly and frequently lethal influenza viruses.”

*Dr. William Mitchell also serves as the independent chairman of the board of Hemispherx.

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 therapeutic rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life-threatening diseases. Because rintatolimod is experimental in nature, it is not designated safe and effective by the FDA for general use and is legally available only through clinical trials.

Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among other uncertainties, while these studies indicated that Ampligen® may enhance the activity of influenza vaccines by conferring increased cross-reactivity and cross-protection, further studies will be required and no assurance can be given that Ampligen® will assist in the development of a universal vaccine for influenza or other viruses. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

Hemispherx Biopharma
Phone Number: 800-778-4042
Email: IR@hemispherx.net 

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/68393178-3be7-4589-b4f6-07cf21de42e3


William Mitchell, MD, PhD, provides a review of the potential role of Ampligen® in creating broader viral coverage of seasonal influenza vaccines