Hemispherx Biopharma Exploring Possible Research Programs in Zika Virus Modeled on a Prior Alferon(R) N Clinical Trial on Closely Related Flavivirus (West Nile)
Both Viruses Transmitted by Identical Mosquito Family
Philadelphia, PA / CRWEPRESSRELEASE / February 9, 2016 - Hemispherx Biopharma, Inc. (NYSE MKT:HEB) announced today that it is beginning to consider study designs for potential tests of the activity and potential uses of its natural alpha interferon (Alferon® N and Alferon® LDO) and rintatolimod (Ampligen®) drug formulations against the Zika virus. The recent orphan drug designations of Ampligen® for Ebola and Alferon® N for MERS viruses by the European Regulatory authorities demonstrates the global need for drugs that possess broad antiviral activities against emerging viruses.
Taxonomy of Flavivirus
Zika virus is a member of the flavivirus family. Like West Nile Virus, both viruses are transmitted by bites of the Aedes aegyptic mosquito. The Zika virus is suspected of causing an increase in babies born in Brazil with abnormally small heads, a serious birth defect known as microcephaly. At present, there are no known vaccines for Zika. The World Health Organization (WHO) estimates there could be 3 million to 4 million cases of Zika in the Americas this year. Recently, cases of Zika infection have also been reported secondary to sexual contact and blood transfusions.
Possible Zika Studies: Hemispherx scientists are exploring the hypothesis that intranasal (IN) use of Ampligen® or oral use of Alferon® in non-pregnant patients with active Zika viral infection could decrease viral load in blood and other body fluids, such as saliva and semen could shorten the time period during which the virus may be transmitted, and/or could decrease viral related tissue pathology. In addition, the symptomatic period may be shortened. This would be similar to the successful approach previously used for Tamiflu in treating early influenza infections.
In rodent studies, Ampligen®, an experimental therapeutic, has shown activity against the Modoc flavivirus induced encephalitis when administered pre- or post-infection, with positive effects on both morbidity (paralysis) and mortality being observed (Antimicrobial Agents and Chemotherapy, 47:777-782, 2003). In another flavivirus model with West Nile virus in different rodent populations intraperitoneally administered Ampligen® increased survival at least 2 fold (Antiviral Chemistry and Chemotherapy, 15:67-75, 2004). A clinical protocol similar to an ongoing seasonal influenza vaccine protection clinical program at the University of Alabama (Vaccine, 32:5490–5495, 2104), is envisioned in which at risk populations would receive Ampligen® delivered intranasally. Other earlier studies have also suggested that such intranasal (IN) administrative routes can be associated with a systemic antiviral and other biological effects of Ampligen®.
Alpha Interferon Tests
Alpha interferons have also shown activity against specific flaviviruses in rodent models. For example, recombinant alpha interferon reduced morbidity (paralysis) and mortality when given either pre+post or post-infection with Modoc virus (Antimicrobial Agents and Chemotherapy, 47:777-782, 2003). Natural alpha interferon (e.g. Alferon® N) could show similar or greater activity if previous findings of 6-80 fold greater activity over recombinant alpha interferons against a variety of different viruses, including MERS, are borne out in studies of flavivirus.
Alpha interferons, including Alferon® N, have previously shown protection against tissue damage in a low dose oral formulation in non-human primates (Antiviral Research, 110:175-180, 2014) against the highly pathogenic avian influenza virus (H5N1). Alferon® LDO (low dose oral) is also generally well-tolerated in human volunteers.
Previous FDA Authorizations for Clinical Trials in Flavivirus and Influenza
Previously, the Company participated in an FDA authorized clinical trial in the flavivirus class against West Nile Virus (WNV) with Principal Investigators at the Weill Medical College of Cornell University. The protocol was entitled “Double-Blind, Placebo-Controlled Trial of Alpha-Interferon (Alferon) Therapy for West Nile Meningoencephalitis”. Many public health officials believe that the new cases of Zika virus are likely to surge in coming months in the Americas. To facilitate ease of treatment in potential new outbreaks of Zika infections, the Company is considering an oral delivery route of Alferon® N, e.g., Alferon® LDO. Alferon® LDO was previously authorized by the FDA for a prevention and treatment study protocol in influenza.
At present, the Company is in active dialogue with governmental representatives within the United States. The Company’s objective is to offer both products to governmental laboratories for further testing.
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
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties including, but not limited to, general industry conditions and competition; general economic factors; the Company’s ability to adequately fund its projects; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Company’s ability to accurately predict the future market conditions; manufacturing difficulties or delays; dependence on the effectiveness of the Company’s patents and other protections for products; and the exposure to litigation, including patent litigation, and/or regulatory actions; 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 and/or any other activities could vary materially from Hemispherx’s expectations. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of Ampligen® in the United States and other countries. 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, if any, of Ampligen® and/or Alferon®, for Zika virus.
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 “potential,” “potentially,” “possible,” 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 Ampligen® will ever be commercially approved for the new potential treatment indications mentioned in this release.
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Source: Hemispherx Biopharma, Inc.