PHILADELPHIA, April 7, 2008 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) today reported that it is accelerating a strategic initiative to explore the therapeutic potential for its experimental therapeutic Ampligen(r) as an adjuvant to vaccines for HIV/AIDS, and for avian influenza ("bird flu"). The stepped-up initiatives follow recent disappointments by other vaccines targeting HIV, as well as new reports in Indonesia that avian influenza now poses an increased threat due to recent mutations of the virus.
Hemispherx has filed a New Drug Application with the U.S. Food & Drug Administration (FDA) for Ampligen(r) as a monotherapy (single-agent treatment) for Chronic Fatigue Syndrome (CFS). In the case of avian influenza and HIV, the Company's researchers are now targeting Ampligen(r) as a vaccine enhancer, utilizing a similar therapeutic mechanism termed "TLR-3 modulator", or broad-spectrum immune modulation strategy.
A Company spokesperson said that as Hemispherx pursues regulatory progress on the overall Ampligen(r) commercialization process, it is pursuing a parallel path in therapeutic needs that extend beyond Ampligen(r)'s initial Chronic Fatigue Syndrome application. Specifically, the recent catastrophic failure of the HIV/AIDS vaccine trials and the growing news regarding a potential Pacific-rim avian influenza epidemic are elevating the importance of the broader-based Ampligen(r) development program. The Company's manufacturing facility is capable of addressing requirements of a multifaceted developmental program.
Background to presently available HIV/AIDS prevention and treatment(1):
* The Merck vaccine candidate V520, as reported by the
International AIDS Vaccine Initiative (IAVI) in November 2007,
was determined to be not efficacious in preventing infection in
human volunteers or reducing the amount of virus in those who
became infected.
* Further analysis suggested that those who received the vaccine
(which cannot cause HIV infection), might have resulted in an
increased susceptibility to acquiring HIV.
* Approximately 39 million people are infected with HIV and three
million die annually of AIDS, which serves to underline the
importance of identifying and developing therapeutic solutions.
* Treatment with antiretroviral therapies is associated with the
development of significant toxicities (diabetes, lipodystrophy,
etc.) as a function of time.
* Antiretroviral therapies (ARVs) prolong the lives of those who
become infected, but for every person who is put on ARV treatment,
there are six new HIV infections.
* As estimated by the U.N. agency on AIDS (UNAIDS), providing
comprehensive AIDS prevention, treatment and care to everyone in
the developing world who needs it will cost at least $45 billion
annually by 2015, more than five times what is being spent today
and jeopardizing other development goals - "Only a vaccine holds
out the hope of eliminating AIDS."
Background on presently available influenza prevention strategies:
* At the International Conference on Bird Flu on March 27, 2008,
Indonesian expert Amin Soebandrio, M.D., reported that the H5N1
virus strain endemic to Indonesia has mutated, and called for
either an increase in tamiflu dosages or the development of a
new medicine to help human victims.
* As reported by AFP on March 18, the UN's Food and Agriculture
Organization called the bird flu situation 'critical' in
Indonesia, where the virus could mutate and cause a human pandemic.
* As reported by Hemispherx in September, 2007, the experimental
therapeutic Ampligen(r) holds promise to overcome the problem
of a limited supply of H5N1 virus vaccine by boosting vaccine
effectiveness. In pre-clinical studies, Ampligen(r) has showed
cross-protection against varying strains of H5N1 influenza
viruses, thus also addressing the problem of potential viral
mutation that potentially rendering existing vaccines
ineffective in the Pacific-rim countries and elsewhere.
Traditional Vaccine Approaches
The International AIDS Vaccine Initiative stated on November 7, 2007, "The failure of the Merck product to prevent HIV infection is not unexpected. Merck's candidate, like nearly all vaccine candidates now in the pipeline, was designed to activate the T-cell arm of the immune system. T-cells work like commando units, traveling through the body, seeking out pathogen-infected cells, which they then kill. Because T-cells only attack cells that are already infected, many scientists, including those at IAVI, think T-cell vaccines are unlikely to protect individuals from becoming infected. It's more likely T-cell vaccines will reduce the amount of virus in people who, once vaccinated, become infected."
Researchers connected with the Hemispherx initiative suspect that HIV is deadly precisely because it invades T-cells. Since HIV undermines T-cell-related immunity, vaccines designed along the lines of V520 candidate may inherently pose the kinds of dangers that were seen in the failed vaccine trial, since HIV may be far more insidious than other pathogens.
Thus Hemispherx researchers believe it may be a flawed strategy for a vaccine to order a direct "commando charge" against an enemy that has proven capable of subverting that commando force, the T-cell system, unless the interaction between the two is modified by using a more holistic approach of providing broad-spectrum enhancement to the immune system. Broad-spectrum enhancement of the immune system may be accomplished by the TLR3 mechanism, secondary to Ampligen(r) exposure.
The Hemispherx Approach
As reported in 2007, intranasal inoculation with an influenza vaccine plus Ampligen(r) may overcome the problem of a limited supply of H5N1 virus vaccine by providing cross-protective mucosal immunity against H5N1 viruses with pandemic potential. In addition to efficacy, the vaccine/Ampligen(r) combination tested showed cross-protection against varying strains of H5N1 influenza viruses. This may be crucial to the fight against H5N1 in light of recent indications that this potentially devastating virus has already mutated. The robust immune/antiviral response is most likely secondary to protective signals emanating from a TLR3 mechanism. In the ongoing work with Japan's National Institute of Infectious Diseases, studies of Ampligen(r)'s potential applications are also being expanded from avian influenza into HIV/AIDS. The NIID researchers are conducting animal studies in the first half of 2008, and these programs complement an initiative with Rockefeller University in the United States.
Hemispherx has provided test drugs to researchers at Rockefeller University and the Aaron Diamond AIDS Research Center on an HIV vaccine approach using Hemispherx's patented strategies with Hemispherx's proprietary dsRNA investigational drugs that target dendritic cells rather than directly stimulating T-cells. This research is funded by a multi-year program of the Bill and Melinda Gates Foundation through the Global Health Initiative. As reported in the current issue of the Proceedings of the National Academy of Sciences (vol. 105, pp 2574-2579), Ampligen(r) (Poly I: Poly C12U) and its congener Poly IC was demonstrated to be effective adjuvants for a dendritic cell targeted HIV/AIDS vaccine that yielded immunity which according to the Rockefeller scientists, was "quantitatively and qualitatively robust and also protective in a lung protection model."
The immune system's dendritic cells may play a key role in boosting the body's own defenses to levels sufficient to ward off HIV infection. The overall objective is to harness dendritic cells' ability to stimulate a wide cross-section of the body's immune response, enhancing both cellular immunity and neutralizing antibodies.
Immature dendritic cells continuously sample their surroundings in the body for pathogens through pattern recognition receptors such as the toll-like receptors (TLRs), which recognize specific chemical signatures found on subsets of various microbes. Contact with a pathogen activates them into mature dendritic cells, which present pathogen fragments to the immune system in a process that activates T-cells. Dendritic cells, which can activate both memory T-cells and naive T-cells, are the most potent of all the immune system's antigen-presenting cells.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced biopharmaceutical 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) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(r) and Oragens(r). Ampligen(r) and Oragens(r) represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 90 patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(r)). 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
(1) November 7, 2007, "IAVI statement on new analysis of STEP large-scale AIDS vaccine trial"
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, change 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. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(r), Alferon LDO and Oragens) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(r) do not imply that the product will ever be specifically approved commercially for these other treatment indications; Similarly, the completion of NDA filing process with Ampligen(r) does not imply that the product will ever be approved commercially.