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Press Release

Hemispherx Notes the Importance of Immunizations During Upcoming National Immunization Awareness Month and Potential of Ampligen in Influenza Vaccine Strategies


Posted on: 03 Jul 18

ORLANDO, Fla., July 03, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American:HEB), an immuno-pharma R&D company focused on unmet medical needs in immunology, is pleased to enthusiastically support National Immunization Awareness Month (NIAM), which is observed annually during August. NIAM is designed “to celebrate the benefits of vaccination and highlight the importance of vaccination for people of all ages,” according to its sponsor, the National Public Health Information Coalition. To learn more about NIAM, please click here. Hemispherx’s reaffirms its commitment to R&D progress in this space which is of critical importance to public health.

Hemispherx is confident about the potential role of Ampligen, one of its patented core technologies, in treating or preventing a range of immune mediated diseases, including influenza. One key area of on-going Hemispherx research is the development of a “universal” influenza vaccine which, would provide multi-year protection against not only seasonal influenza strains, but also those with the potential to cause lethal global dipandemics.

Ampligen is a selective toll-like receptor 3 agonist capable of inducing innate and adaptive immune responses. In a human intranasal vaccine study of Ampligen plus FluMist, the combination was shown to be well-tolerated. Moreover, patients in the Ampligen plus FluMist treatment group produced antibodies against highly lethal avian influenza viruses including H5N1 and H7N9 that were not present in the immunizing vaccines. Pathogenic avian strains of influenza with high mortality in humans remain a clear and present human danger of being spread by potentially devastating influenza pandemics.

Hideki Hasegawa, MD, Director, Department of Pathology (National Institute of Infectious Diseases, Japan) stated, “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.”

Edgar Turner Overton, MD, Associate Professor, Division of Infectious Diseases, University of Alabama School of Medicine stated, “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 opportunity to develop a globally effective influenza vaccine is an important part of our overall development strategy for Ampligen,” said David R. Strayer, MD, Chief Science and Medical Officer of Hemispherx. “Studies conducted on the activity of Ampligen in combination with influenza vaccines suggest that intranasal immunization with Ampligen as an adjuvant may provide an effective and well-tolerated means of protecting at-risk humans.”

The global influenza vaccine market is estimated to exceed $3 billion in 2018, according to the World Health Organization. It is projected to achieve a compound annual growth rate of 6.93% from 2017 to 2023, to reach $4.6 billion by 2023, up from an anticipated  $3 billion in 2018, according to market research firm Research and Markets. “Hemispherx is seriously exploring co-development partnerships with influenza vaccine producers. Our goal is to make a positive difference in viral vaccines, both in terms of enhanced effectiveness and cross-reactivity and cross-protection. We have focused our R&D on three key areas, immuno-oncology, ME/CFS, and vaccine enhancement. Our belief is strong that our vaccine work can and will make an important difference for improved public health in the future,” states Tom Equels, CEO at Hemispherx.

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology. Hemispherx's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer reviewed pre-clinical studies and clinical trials, Hemispherx believe that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® already conducted by Hemispherx include studies of the potential treatment of cancer patients with renal cell carcinoma and malignant melanoma, CFS, Hepatitis B and HIV. All of these potential uses will require additional clinical trials to generate the safety and effectiveness data necessary to support regulatory approval. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system. Commercialization of Ampligen® in Argentina will require, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch (including possible requirements for approval of final manufacturing) and we most likely will need additional funds to manufacture product at a sufficient level for a commercial launch.

Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, 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. 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.

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

GlobeNewswire
globenewswire.com

Last updated on: 04/07/2018

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