Unexpected neurological damage spreads with WNV
Hemispherx Biopharma, of Philadelphia, PA, US, is testing a highly purified form of alpha interferon, Alferon N Injection, in a Phase III clinical trial to determine its relative benefit in treating West Nile Virus (WNV).
Hemispherx Biopharma, of Philadelphia, PA, US, is testing a highly purified form of alpha interferon, Alferon N Injection, in a Phase III clinical trial to determine its relative benefit in treating West Nile Virus (WNV).
WNV has spread to 40 states in 2004, with The Wall Street Journal (WSJ) reporting that the range of cases varies from a few cases in some states to 583 cases reported in California. An unexpected finding described in the WSJ article is the unusually long recovery time even in the 'mild' cases, which had an unexpectedly long median recovery period of 60 days according to a study reported in the September issue of Annals of Internal Medicine. Permanent neurological damage as well as death are also being reported and are contributing to the national emergency to find a definitive treatment to save lives, preserve neurological function and hold down long-term hospital costs.
WNV, which was first reported in New York in 1999, has now spread virtually across the entire United States. Mosquitoes and birds may be carrying the virus and it appears that a single bite from an infected mosquito can cause the disease, unlike some other viral diseases (e.g. dengue virus) that require multiple bites from mosquitoes carrying the viruses. There is no approved therapeutic intervention and accordingly Hemispherx Biopharma have started this Phase III trial.
Alferon N is already approved for sale by the FDA for a different viral disease, refractory human papilloma virus (HPV), which has an estimated 1m new cases per year according to National Institutes of Health. In order to accelerate the implementation of its WNV protocol and the evaluation of Alferon N's potential utility, Hemispherx Biopharma is strategically placing the test drug in hospital formularies where new outbreaks have been recently reported, especially in the Midwestern and Western states. A nationwide study is being conducted in conjunction with Dr. James Rahal, an infectious disease expert at Cornell University's Weill College of Medicine.
About Alferon N Injection
Alferon N (Interferon alfa-n3, human leukocyte derived) is a highly purified, natural source, glycosylated, multispecies alpha interferon product, composed of eight forms of highly purified alpha interferon. It is the only natural-source, human multispecies alpha interferon sold in the US and is approved for the treatment of refractory papilloma by various regulatory agencies worldwide. By contrast, recombinant, non-natural source, interferon is composed of only one form and thus lacks the potential for synergistic therapeutic activity.