Hemispherx Biopharma and Bioclones, a Leading South African Biotechnology Company, Join Forces on Novel Therapeutic Cancer Vaccine
Builds on Recently Issued Patent Estates of Both Companies and Basic Research / Clinical Advancement in Cancer Control
PHILADELPHIA, July 14, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), announced a strategic alliance to develop multiple projects with Bioclones (Pty) Ltd. ("Bioclones"), a leading South African biotechnology company.
On June 25, 2014, Bioclones and Hemispherx concluded strategic discussions in Johannesburg with three principle goals; 1) initiating studies utilizing Ampligen(R) as a potential adjuvant enhancement of Bioclones' therapeutic cancer vaccine, currently in clinical trials in Cape Town, including pre-clinical studies followed, potentially, by a Phase 1 clinical trial; 2) seeking South African Medicine's Control Council approval to conduct trials using Alferon(R) to eradicate the HIV virus in patients highly responsive to anti-retroviral therapy (HAART); and 3) initiating a joint effort to obtain commercial registration of both Ampligen(R) and Alferon(R) in the South African markets.
The first clinical program builds on the Bioclones patented (US Patent 7,981,673 entitled "Process for the maturation of dendritic cells and a vaccine") therapeutic human dendritic cell (DC) cancer vaccination approach. This invention provides a method of producing mature DCs in vitro, which comprises the step of culturing the immature DCs, thereafter exposing said cells to tumor antigens before administration to patients. The team has successfully obtained the necessary Ethics approval to use Ampligen(R) as an adjuvant in the Bioclones pre-clinical cancer immunotherapy program utilizing patient derived samples. Pre-clinical studies will be directed towards the potential treatment of breast cancer in particular, followed by prostate cancer. These studies are part of the effort to develop patient-specific DC immunotherapy vaccines against breast cancer and prostate cancer, which elicit an immune response that will target and kill cancer cells. Human DCs matured with Ampligen(R) and transfected with autologous tumor-specific mRNA are designed to elicit a potent and autologous tumoricidal antigen-specific cytotoxic response to the cancer.
Similar programs were successfully developed in the US at the Dendreon Corp., and Hemispherx currently has existing immunotherapy studies in the US at the University of Pittsburgh Comprehensive Cancer Center and the Georgia Regents Research Institute. The Bioclones collaboration is designed to enlarge and enhance the potential clinical results with the US based programs.
Ismet Amod, CEO of Bioclones, stated, "We and the University of Cape Town based research team led by Kamsellin Chetty are very excited about securing Ampligen from Hemispherx for the clinical work on dendritic cell vaccine technology which is an essential component in our novel treatment to fight cancer."
The already substantial Hemispherx patent estate related to Ampligen(R) was recently expanded with a new composition of matter patent. On May 13, 2014, the United States Patent Office issued patent US 8,722,874 B2 titled "Double-Stranded Ribonucleic Acids with Rugged Physiochemical Structure and Highly Specific Biologic Activity" to Hemispherx Biopharma, Inc. The patent describes a novel form of rugged dsRNA, which is a key component of the company's experimental drug Ampligen(R), and which displays a unique composition and physical characteristic identified with high specificity of binding to Toll-Like Receptor 3 (TLR3), thereby conveying an important range of therapeutic opportunities. The Hemispherx inventors discovered, using highly sophisticated analytical methods, that within the mixture of Ampligen(R) RNAs of different sizes and molecular configurations, a highly specific subset of molecules -- not previously known to exist -- in fact convey a disproportionately higher percentage of the resultant biological activity believed to be important in the immunotherapeutic response to cancer.
Thomas Equels, Executive Vice Chairman of Hemispherx, stated, "This is another important step forward in the globalization of Hemispherx as well as the sharing of our important experimental immune system therapies with the world. We look forward to collaborating with Bioclones, our partner in South Africa, as we work together to maximize the potential use of Ampligen(R) and Alferon(R) in the treatment of cancers and HIV."
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(R) and the experimental therapeutics Ampligen(R) and Alferon(R) LDO. Ampligen(R) 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(R) and Alferon(R) 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(R)), approved for sale in the U.S. and Argentina. The Company's Alferon(R) N approval in Argentina includes the use of Alferon N Injection(R) (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 additional steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of the Ampligen(R) NDA for the treatment of Chronic Fatigue Syndrome in the United States. 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(R) 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(R) 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 and/or any other activities could vary materially from Hemispherx's expectations.
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