PHILADELPHIA, July 8, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), announced execution of an agreement to seek South African government approval to initiate a study of Alferon® N, the only FDA approved natural interferon, in the suppression of HIV Type 1 replication and the reduction/elimination of functional cell-associated HIV DNA integration (latent HIV). The study is contemplated as part of a broad strategic alliance with Bioclones (Pty) Ltd. ("Bioclones"), a leading South African biotechnology company.
At the Wistar Institute, University of Pennsylvania, a recent clinical study was conducted to test the effect of Interferon Alfa-2a in the suppression and/or eradication of HIV (Pegylated Interferon Alfa-2a Monotherapy Results in Suppression of HIV Type I Replication and Decreased Cell-Associated HIV DNA Integration; Azzoni, et al. J Infect Dis, 207:213-222, 2013). This pilot study yielded an exciting conclusion: alpha interferon resulted in control of HIV replication in 45% of patients following cessation of anti-retroviral therapy. Decreased levels of latent HIV (chromosomal integrated HIV provirus responsible for chronic infection non-responsive to current approved anti-retroviral drugs) occurred in patients in which HIV replication was suppressed by anti-retroviral drugs, supporting a role for immune-mediated approaches in HIV suppression and potential eradication of latent virus required for cure. Hemispherx' flagship products, Alferon® N and Ampligen® (experimental) are both potentially key players in successful long-term immune-mediated therapy.
Hemispherx' product, Alferon® N, is a natural interferon that has certain apparent advantages over recombinant (synthetic) interferons. First, unlike synthetic alpha interferons which typically are single species, Alferon® N is a multi-species alpha interferon. In a side-by-side clinical comparison, it has a superior safety profile relative to a commercially available synthetic interferon and can be successfully used in the treatment of certain refractory patients. In some studies, Alferon® N produces more antiviral control (Fan, et al, AIDS Research and Human Retroviruses, 9(11):1115-1122, 1993) and less neutralizing antibody formation compared to synthetic interferons (Strayer and Carter, J IFN and Cytokine Res, 32(2):95-101, 2012). It is the only natural source alpha interferon product currently approved by the FDA in the U.S. Alferon® N is also approved for sale in Argentina for an unrestricted indication of patients that fail or become intolerant to treatment with recombinant interferons (http://www.hemispherx.net/content/investor/default.asp?goto=742).
Hemispherx and Bioclones will co-sponsor the clinical study of the safety and biological effects, including clinical, immunologic, and virologic assessments, of adding Alferon® N to a strategic therapeutic intervention protocol in 30 South African patients with HIV. Bioclones, a global partner to Hemispherx, will serve as the Company's South African representative and will organize the trials to take place in South Africa.
In the Wistar article, Interferon Alfa-2a immunotherapy resulted in control of HIV replication and decreased levels of HIV-1 integrated provirus, supporting a role for immune-mediated approaches in HIV suppression and/or eradication. The objective of the Bioclones/Hemispherx program is to build on the Wistar results by increasing the complete response rate.
Ismet Amod, CEO of Bioclones, stated, "From a global perspective Bioclones will be able to provide an African context for the use of both Alferon® in the fight against the HIV AIDS virus for the first time in South Africa and both our companies are committed to advancing the cause against the spread of the HIV AIDS virus and make a difference in the lives of all that are affected by the disease."
Thomas Equels, Executive Vice Chairman of Hemispherx, stated, "Hemispherx is pleased to co-sponsor upcoming clinical trials in South Africa using Alferon® N in the treatment of patients with HIV. Together with Bioclones, we look forward to seeking authority from the South African government to commence the trials as soon as possible. Both of our companies are ready to bring our talents to the global fight to eradicate AIDS."
About Bioclones
Bioclones is a South African-owned biotechnology company dedicated to the manufacture of modern biotechnology products for human pharmaceutical use as well as the development of biotechnology infrastructure and skills across the African continent. It was established in 1982 and is the largest biotechnology company in this field in South Africa.
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
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, below, 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.
Disclosure Notice
The information in this press release includes certain "forward-looking" statements including without limitation statements about the ability to gain the South African government approval to initiate a study of Alferon® N, the only FDA approved natural interferon, in the suppression of HIV Type 1 replication and the reduction/elimination of functional cell-associated HIV DNA integration (latent HIV) in South Africa 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 and/or any other activities could vary materially from Hemispherx's expectations.