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Hemispherx Biopharma (HEB) And Researchers With The University of Alabama at Birmingham To Discuss Clinical Trial Studies Aimed At Developing A Universal Influenza Vaccine To Prevent Pandemic Influenza Threat


1/27/2014 10:42:54 AM

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WASHINGTON, DC - January 27, 2014 - Hemispherx Biopharma (NYSE MKT: HEB) announced today that the ASM Biodefense Meeting is scheduled for January 27-29, 2014 at the Washington Marriott Wardman Park Hotel, Washington DC. The University of Alabama and Hemispherx peer reviewed presentation is entitled “Seasonal Influenza Vaccine and a TLR-3 Agonist, Rintatolimod (Ampligen®), Given Intranasally Produced Cross-Reactive IgA Antibodies Against Pathogenic H5N1 Influenza HA” and will be provided in poster format by Dr. E. Turner Overton, an infectious disease expert at UAB, in the afternoon of January 29, 2014. The abstract of the presentation will be simultaneously available on the Hemispherx website. Ampligen® (rintatolimod) is an experimental therapeutic.

Of special concern regarding avian influenza infections in humans is the impact of travel related to the Chinese New Year and recently reported mutations in the avian influenza viruses expected to increase virulence and morbidity.

As officials with the Centers for Disease Control and Prevention report widespread flu activity this season in the U.S., Chinese health officials are announcing rising cases of the deadly bird flu virus, H7N9, and two deaths (Canada and Vietnam) from another deadly avian influenza virus, H5N1, have already been reported this year. Thus, influenza epidemics continue to represent a significant medical problem around the world. Even with existing vaccines, annual influenza epidemics typically results in 20-50 million cases, resulting in 30,000-40,000 deaths in the U.S. alone. A possible pandemic of avian H5N1 or H7N9 could have even more devastating consequences.

Representatives of Hemispherx Biopharma, Inc. and Prof. Overton, the principal researcher conducting the clinical trial at the University of Alabama at Birmingham, will describe the results to date of the Ampligen®/FluMist® intranasal influenza vaccine clinical trial and address questions during a media conference at the National Press Club in Washington, DC scheduled on Thursday, January 30 at 10 a.m. following the formal presentation at the ASM Biodefense Conference.

The current flu vaccines used in the United States have a number of disadvantages including slow and expensive manufacturing, and reduced efficacy in elderly, children and immune-compromised populations. These weaknesses could be multiplied during a pandemic. The use of Ampligen®, an experimental therapeutic, as a candidate adjuvant combined with FluMist® (a commercially available vaccine) may have potential advantages as compared to traditional inactivated vaccines: including intranasal administration and potential generation of a broader immunity at the natural site of entry of the influenza virus. The stimulation of cross-protection against pre-pandemic H5N1 avian influenza strains is an ongoing clinical research goal. As FluMist®, due to its intranasal administration, imitates the natural entry of the influenza virus, it is already known to generate local 'first-line' immunity as well as the traditional systemic immunity. The objective of the proposed “vaccine cocktail” is to enable potentially wider immunity, including additional protection against a variety of highly pathogenic influenza viruses.

Briefing Details:

- Date: Thursday, January 30, 2014

- Time: 10:00 a.m. – 11.00 a.m.

- Location: National Press Club, Lisagor Room (529 14th Street NW, 13th Floor, Washington, DC 20045)

Panelists:

- Dr. William A. Carter (Moderator), Hemispherx Biopharma, Inc., Chairman and CEO

- Edgar Turner Overton, M.D. (Speaker), Principal Researcher, University of Alabama at Birmingham Department of Medicine, Division of Infectious Diseases

About Dr. William A. Carter

Dr. Carter, the co-inventor of Ampligen®, joined the Company in 1978, and has served as the Company's Chief Scientific Officer since May 1989, the Chairman of the Company's Board of Directors since January 1992, the Company's Chief Executive Officer since July 1993, the Company's President since April, 1995, and a director since 1987. From 1987 to 1988, Dr. Carter served as the Company's Chairman. Dr. Carter was a leading innovator in the development of human interferon for a variety of treatment indications including various viral diseases and cancer. In this context, he received the first FDA approval to initiate clinical trials on a beta interferon product manufactured in the U.S. under his supervision. From 1985 to October 1988, Dr. Carter served as the Company's Chief Executive Officer and Chief Scientist. He received his M.D. degree (with honors) from Duke University and underwent his post-doctoral training at the National Institutes of Health and Johns Hopkins University. Dr. Carter also served as Professor of Neoplastic Diseases at Hahnemann Medical University, a position he held from 1980 to 1998. He also served as Director of Clinical Research for Hahnemann Medical University's Institute for Cancer and Blood Diseases, and as a professor at Johns Hopkins School of Medicine and the State University of New York at Buffalo. Dr. Carter was a recipient of a Research Career Award from the National Institute of Health while serving on the faculty of Johns Hopkins Medical University. He is a Board certified physician, Fellow of the American College of Physicians and author of more than 250 scientific articles, including the editing of various textbooks on anti-viral and immune therapy.

In addition to the peer-reviewed articles on antiviral therapy, he has been Editor of two major textbooks, including “Selective Inhibitor of Animal Viruses” which went thru more than 10 printings. He was Principal Investigator on numerous large NIH Program Project Grants in the area of antiviral and cancer therapy, with annual budgets of several million dollars. Dr. Carter initiated the first clinical studies in a number of diseases in which interferon is now the treatment of choice, including chronic viral hepatitis and multiple sclerosis. He is inventor, or co-inventor of several hundred patents that are exclusively licensed to Hemispherx Biopharma.

About Dr. Edgar Overton, M.D.

Dr. Overton is board certified in both Internal Medicine and Infectious Diseases and currently serves as the Medical Director for the Ryan White funded UAB 1917 HIV Clinic and as the Medical Director for the recently created Viral Hepatitis Clinic at the 1917 Clinic which offers comprehensive care for HCV-infected persons. He is an Associate Scientist at the UAB Center for AIDS Research (CFAR) and serves as the Co-Chair for the Clinical Core of the CFAR.

Dr. Overton’s research interests include assessing vaccine responses in different patient populations. He currently serves as a member of the Protocol Committee within the HVTN, overseeing protocol development and manuscript submission, and as a co-chair for a Phase I clinical trial evaluating a polyvalent prime/boost HIV vaccine strategy. Dr. Overton has led studies evaluating novel vaccines and vaccine strategies against several different pathogens, including HIV, hepatitis A, hepatitis B, HPV, VZV, anthrax, smallpox, and influenza.

About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and 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.

About University of Alabama at Birmingham Medical Center

Fellows and faculty actively participate in teaching and patient care at the three major hospitals within the University of Alabama at Birmingham Medical Center. Their strong clinical presence is evidenced by two separate consult services (one in the 1100 bed University Hospital which focuses on opportunistic infections in compromised hosts such as BM and solid organ transplant recipients, bone/joint and CNS infections in orthopedic, trauma and neurosurgical patients, and infections in neutropenic/cancer patients; another service combines HIV/AIDS consultation at University Hospital and general infectious diseases consultation at the VA Medical Center and the county hospital). ID faculty and fellows also provide care in a cross-section of ambulatory clinics which target general ID, HIV/AIDS, STD, tuberculosis and international travel.

Forward-Looking Statements

The foregoing release contains forward-looking statements that can be identified by words such as "will be, investigative, interim" or similar terms, or by express or implied discussions regarding potential efficacy for Hemispherx’s Ampligen®, or regarding potential future revenues from Ampligen®. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of Management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Ampligen® will receive regulatory approval or be commercially successful in the future. In particular, management's expectations regarding Ampligen® could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the Company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors 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 on file with the U.S. Securities and Exchange Commission. Hemispherx is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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 the capital improvement and 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 the 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 the 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.

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