PHILADELPHIA, Jan. 26, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the “Company” or “Hemispherx”), announced today that in a new publication in the journal mBio, scientists at the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID), Harvard University, and Massachusetts Institute of Technology (MIT) studied genetic changes in the Ebola virus (EBOV) circulating in West Africa and concluded that genomic drift of the EBOV over time may be sufficient to block the action of otherwise potential therapies that target EBOV genetic sequences. The types of potential drugs at risk include monoclonal antibodies and small-interfering RNA (siRNA) which are scheduled to be evaluated during the current outbreak (see below). The USAMRIID press release states that “genetic drift must be considered when developing potential therapeutics, in order to ensure that changes in the Ebola virus over time do not render those treatments ineffective……the USAMRIID team compared the current strain, called EBOV/Mak, with the two previous strains that caused outbreaks in 1976 and 1995 in Zaire (now the Democratic Republic of the Congo). In each comparison, they found more than 600 genetic mutations. Next, the group focused on only the mutations that occurred in the genetic sequences targeted by the experimental therapeutics. Of these, they found 10 new mutations that might interfere with the mechanisms of the sequence-based drugs currently being tested. Three of these mutations appeared during the current West African outbreak.” (http://www.usamriid.army.mil/newsroom.htm).
The two platform drugs of Hemispherx, Alferon® N and Ampligen®, both experimental therapeutics in a setting of Ebola disease, have recently both demonstrated anti-EBOV activity (see Hemispherx’ Press release dated November 3, 2014 http://www.hemispherx.net/content/investor/default.asp?goto=805) and have mechanisms of action which are multifaceted by working through cellular “molecular cascades” rather than by targeting viral protein or genetic sequences whose specificity is vulnerable to mutational change as reported by the research consortium on January 20, 2015. Cellular antiviral pathways of innate immunity are not subject to the mutational pressures of rapidly dividing viruses, which suggests that - even in the face of viral mutation – biological modifier products activating innate immunity are likely to continue to show sustained biological activity.
Although none of the experimental drugs have been approved by the U.S. Food and Drug Administration (FDA), certain of the experimental therapeutics discussed in the USAMRIID/Harvard/MIT report, are being used to treat small numbers of patients under a World Health Organization (WHO) emergency protocol. The potential impact of genomic drift on development of therapeutics for EBOV disease has already been realized for other pathogenic human virus, such as HIV and influenza. The large genetic and antigenic diversity seen in HIV has been a “major stumbling block” for development of preventative vaccines (Ndung’u, et al. AIDS 2012;26(10):1255-60).
In a highly mutational rate setting, use of antiviral drugs that target genomic or protein sequences, may accelerate the onset of drug resistant viral strains, as has been reported previously with influenza and application of Tamiflu (Chao, et al. J R Soc Interface 2012;9(69):648-56).
About Alferon® N
Alferon® N is the only natural source, multi-species alpha interferon currently approved for sale in the U.S. Alferon® N is approved in the U.S. for the treatment of refractory or recurring external genital warts caused by human papilloma virus in patients 18 years of age, or older. Positive results against Ebola in vitro have been reported to the Company by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). Clinical trial data will be necessary to establish human efficacy of Alferon® N for Ebola virus.
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 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. Animal testing is underway and clinical protocol development is also being pursued. Clinical trial data will be necessary to establish human efficacy of Ampligen® for Ebola viruses.
About U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)
USAMRIID’s mission is to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents. Research conducted at USAMRIID leads to medical solutions—vaccines, drugs, diagnostics, and information—that benefit both military personnel and civilians. The Institute plays a key role as the lead military medical research laboratory for the Defense Threat Reduction Agency’s Joint Science and Technology Office for Chemical and Biological Defense. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities (“biological modifiers”) for treatment of seriously debilitating disorders especially life-threatening viruses. 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 including cancers. 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 FDA approval of Alferon® N Injection® is limited to the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. The Company’s Alferon N Injection® 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. Some newer regimens for creating apparent “cures” in chronic active hepatitis C disease require interferon as a vital component of a successful treatment regimen. 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.
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 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. Clinical trial data will be necessary to establish human efficacy of Ampligen® or Alferon® for Ebola virus disease.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “intends,” “plans,” and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above, as well as the risks 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. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof. No evidence is suggested that Alferon® N, Alferon® LDO and/or Ampligen will ever be commercially approved for the new potential treatment indications mentioned in this release.
CONTACT: Company/Investor Contact Charles Jones CJones & Associates Public Relations Office: 888-557-6480 Cell: 305-987-7418 Email: cjones@cjonespr.com
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