PHILADELPHIA, Feb. 4, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), presented a summary of the results of its Phase I/II study from the poster presentation entitled "Seasonal Influenza Vaccine and a TLR-3 Agonist, Rintatolimod (Ampligen®), Given Intranasally Produced Cross-Reactive IgA Antibodies Against Pathogenic H5N1 Influenza HA" given at the American Society for Microbiology (ASM) Biodefense Conference in Washington, DC on January 30, 2014.
When FluMist®, a seasonal influenza vaccine, was administered intranasally in conjunction with Ampligen® (an experimental therapeutic), 92% of the subjects elaborated specific IgA antibodies against at least one of the homologous seasonal vaccine strains. Healthy volunteers also showed, surprisingly, enhanced IgA levels against emerging avian influenza viruses with the potential for causing a pandemic in humans. These antibodies were against one or more of 3 different strains of H5N1, H7N9, and H7N3. Two-thirds of these recipients showed a ≥4-fold increase in specific IgA levels over baseline and some had measurable IgA levels one year after receiving FluMist® in conjunction with Ampligen®.
A published challenge study in adults (aged 18-45) indicates that FluMist® alone generates ≥4 fold increase in serum HAI antibody response (a level thought to be protective) in 24% of recipients despite the fact that 85% of recipients were estimated to have been protected (Treanor, et al. (2000) Vaccine, 18:899). In Europe FluMist® is approved for individuals aged 2-17 compared to ages 2-49 in the US.
Dr. William Carter, CEO at Hemispherx, indicated that compared to systemic doses of Ampligen® used in other clinical studies, the amount of intranasal Ampligen® used in this study was as low as one eight thousandth (1/8,000) of the dose. In response to a question about safety, Dr. David Strayer, Medical Director at Hemispherx, indicated that there were no serious adverse events reported during the study and over 80% of the adverse events reported were mild.
The breath of immune response suggests that other groups, particularly vulnerable to influenza and unprotected by FluMist® alone, might benefit from an appropriate addition of an adjuvant.
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.
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
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 the aforementioned study when FluMist®, a seasonal influenza vaccine, is administered intranasally in conjunction with Ampligen® (an experimental therapeutic) could vary materially from Hemispherx's expectations.