|February 09, 2015
|Hemispherx Biopharma Posts USAMRIID Ebola Study Concluding Ampligen® Produced 100% Survival Rate in Rodents with 100% mortality in placebo.
|Hemispherx Challenges False Accusations in Recent Online and Social Media Postings
Philadelphia, PA, Monday, February 09, 2015: Based upon numerous Hemispherx stockholder requests, Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the “Company” or “Hemispherx”) has posted the report and findings of the recent efficacy study of Ampligen® in a mouse model of Ebola virus infection performed by scientists at the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID). The posted USAMRIID report conclusively refutes false and defamatory blog and online statements by TheStreet.com’s blogger Adam Feuerstein and invalidates Feuerstein’s negative social media postings about the company’s press release that was issued on February 2, 2015.
As requested by stockholders, the USAMRIID report can now be viewed in its entirety on the company’s website: www.hemispherx.net.
“Anyone who reads the USAMRIID report can see Feuerstein is wrong. This is blatant short mongering at its worst,” said Thomas K. Equels, Hemispherx’ Executive Vice Chairman. “Feuerstein’s defamation of these results hurts not only the company’s stockholders; it impedes development of an important experimental therapeutic that could save thousands of lives in West Africa.”
Equels said, “This recent study is breakthrough information regarding Ebola therapy. The US Army scientists challenged mice with a mouse adapted Ebola virus. 100% of the Ampligen® treated mice at the lowest dose of 6 mg/kg survived the 21 day course of the experiment. However, the placebo group challenged with Ebola all died within seven days. Ampligen activates the innate immunity inhibited by the Ebola virus and is relatively insensitive to viral mutational drift, which remains a potential problem for developmental therapeutics that are dependent on invariant targets of viral protein structure. No other host immune based experimental therapy, that we are aware of, has achieved to date similar results in animal experimentation against the Ebola virus. Further, Ampligen® has an extensive long-term safety record in humans derived from our clinical work. The safety profile is appropriate given the high and rapid mortality rates from Ebola. Unlike other experimental therapies, a stockpile supply of the experimental therapeutic Ampligen® is available.
Hemispherx believes erroneous short seller rhetoric cannot be without consequence in the biotech industry. False statements such as Feuerstein’s must, at a minimum, be corrected publicly. “Mr. Feuerstein maligned this important discovery by choosing to focus on falsely discrediting this information and even questioning the collaboration of Hemispherx’s with USAMRIID,” said Equels. “Our collaboration with USAMRIID was centered solely on conducting these Ebola efficacy tests, in vitro and in vivo, in their independent government laboratory. The now publicly posted report is irrefutable proof of the collaboration between USAMRIID and Hemispherx. It is also irrefutable proof of the positive results obtained in this study. These results compel Hemispherx to move forward its experimental therapeutic Ampligen® in the fight against this dread disease plaguing West Africa and to continue to work diligently with the Food and Drug Administration (FDA) and other international organizations committed to the effort to mitigate the ongoing morbidity and mortality of Ebola.”
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. Clinical protocol development is being pursued. Clinical trial data will be necessary to establish human efficacy of Ampligen® for Ebola viruses.
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. 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.
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. Findings from animal studies may not correlate with results from humans. Clinical trial data will be necessary to establish human efficacy of Ampligen® or Alferon® for Ebola virus disease.
CJones & Associates Public Relations
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.