Antiviral Therapy Triggers "Guardian Angel Genes”

Clinical trials have been initiated for an accelerated assessment of the antiviral/immunodulatory agent, Alferon LDO (low-dose oral interferon alfa-n3), as a potential experimental therapy for the avian flu and other deadly viral diseases that have very high death rates.

The agent, developed by Hemispherx Biopharma, Inc. (Philadelphia, PA, USA), is being evaluated in human volunteers in both the United States at Drexel University (Philadelphia, PA, USA) and shortly at the Princess Margaret Hospital (Hong Kong). The clinical trials are designed to determine whether Alferon N, delivered in a new oral drug delivery format, can reactivate the broad-spectrum immunostimulatory and antiviral genes, known as "guardian angel” genes. These human genes are inactivated by deadly viral infections including smallpox and the avian flu.

The U.S. Centers for Disease Control have recently announced that they have been performing "risky” in vitro studies, which are simulating the mixing and matching of genes between the avian flu virus and a common human flu virus. Such recombination genes could grow into a pandemic situation, stressing the intense scientific interest in this molecular field.

Dr. Brain Williams from the Cleveland Clinic (OH, USA) will be the research collaborator in the clinical trials. His team of scientists have already identified many of the interferon- (IFN)-related genes that are the topic of the present clinical investigation. In the prospective clinical trials, blood samples will be tested for gene activation after brief exposure to Alferon N to the buccal (oral) mucosa of study participants.

Immunity against viruses usually takes two forms: innate immunity and "learned” (adaptive) immunity. The U.S National Institutes of Health (NIH; Bethesda, MD, USA) is currently studying adaptive immunity by launching nationwide vaccine testing against the avian flu. The vaccines appear promising but may have the disadvantage of minimal benefit in individual post-viral exposure; vaccines can also become rendered useless in the event of viral mutation (typically seen with the flu viruses and HIV/AIDS viruses).

By contrast, the innate immune system, having evolved over thousands of years to work within moments of finding viruses, have been shown to stop or kill infections in animal models. In addition, because innate immunity functions by way of immune cascades (multiple steps of viral blockade), mutation to resistance by the virus may be more difficult.

Hemispherx and other biotechnology companies are currently assessing genetic-based research applications to possibly reverse the complications of these deadly viruses.




Related Links:
Hemispherx Biopharma