PHILADELPHIA—Hemispherx Biopharma Inc. announced in early December that it has received a new research report (dated Dec. 5) from researchers at Howard University in Washington, D.C., describing a study in which Ampligen (Poly I : Poly C12U) strongly inhibited the Ebola minigenome in the human embryonic kidney cell system.
The Ebola minigenome replication system was recently described by the researchers earlier this year in the Journal of Biological Chemistry in “Role of Protein Phosphatase 1 in Dephosphorylation of Ebola Virus VP30 Protein and Its Targeting for the Inhibition of Viral Transcription.” In the minigenome replication system, certain genetic information for viral proteins has been deleted from the genomic array to permit safer and more efficient laboratory manipulations.
Most importantly, the current Howard University results, taken in conjunction with previous data on anti-Ebola actions of Ampligen reported by other U.S. and European collaborators, indicate that the antiviral molecular actions of Ampligen may be triggered at levels reached by the common human treatment regimens of Ampligen which have historically been used in clinical studies in a variety of other human diseases. These regimens of Ampligen, an experimental therapeutic, have been deployed to date over 100,000 times in over 1,000 patients. Today's report also extends the histologic range of human cell types in which Ampligen has demonstrated strong bioactivity against Ebola at low drug concentrations. Ebola is known to multiply in many different parts of the body destroying multiple types of cells, leading to high morbidity and mortality rates.
Recent research has indicated that in subsets of severely ill Ebola virus disease patients, parenteral therapy, rather than oral based treatments, will be necessary. The experimental therapeutic Ampligen may be able to meet this requirement.
Previously, Italian researchers reported that Ampligen can successfully bind to the lethal Ebola virus disease viral protein designated VP35. VP35 protein normally inactivates a patient's immune/antiviral system by binding to viral dsRNA, thereby sequestering a critical antiviral/immune activator of the body which leads to high morbidity and death rates. These experimental outcomes are consistent with recent predictions published in Emerging Microbes and Infections by affiliates of Hemispherx.
Hemispherx notes that it will continue seeking approval for commercialization of Ampligen in the United States and abroad as well as to widen existing commercial therapeutic indications of Alferon N Injection presently approved in the United States and Argentina. In addition, the company has formed collaborations with multiple research laboratories around the world to examine Ampligen and Alferon N, as potential preventatives for, and treatments of, Ebola virus disease.
SOURCE: Hemispherx Biopharma
