Globavir To Seek Compassionate Use Approval For Ebola Treatment
By Cyndi Root
Globavir Biosciences announced in a press release that it plans to seek Food and Drug Administration (FDA) approval for a novel Ebola treatment by the end of the year. The biotechnology company based in California is seeking approval through the FDA’s compassionate use regulatory pathway. Globavir’s GBV006 is a combination of FDA approved drugs and is intended to treat the deadly Ebola virus in West Africa that has killed over 1,000 people and is sparking fear of a pandemic in the hearts of many around the world.
Shalabh Gupta, M.D., CEO of Globavir, said, "The situation in West Africa is dire, and there is an immediate need for drugs able to reduce the impact of Ebola infection. By repurposing a combination of approved drugs to treat Ebola virus, Globavir has the potential to overcome many hurdles regarding safety and supply of experimental therapies. We hope to quickly form partnerships to distribute this potentially life-saving drug to those who need it most."
GBV006
GBV006 was discovered at Stanford University School of Medicine in Palo Alto, CA, and is one of several drug combinations being tested for Ebola and other infectious diseases. GBV006 shows promise in several stages of the viral lifecycle including viral entry and maturation, which are critical stages in Ebola, the West Nile virus, and Dengue. Rather than targeting the DNA or viral proteins directly as other novel treatments do, GBV006 targets the human cell machinery operative in viral replication. Therefore, Globavir’s technology is useful in virus families or viruses with similar mechanisms of action. Another agent, GBV001, has been shown in animal models to be effective in Dengue virus infection, and Globavir will seek approval to begin clinical trials with it this fall.
The component drugs in GBV006 have been tested at already approved doses, which are well-tolerated by patients. The experimental models showed that GBV006 is effective against Ebola at low micromolar concentrations in vitro. Globavir intends to use previously established safety and efficacy data for the component drugs to position GBV006 as an experimental treatment.
About Ebola
Ebola is also known as hemorrhagic fever. It originated in West Africa where it originated in animals and was passed to humans. African antelopes, primates, and bats are the primary suspects in its transmission and people may have contracted it by eating bushmeat or coming into contact with an animal’s feces, urine, or vomit. Most victims show symptoms within a few days and die from massive internal organ failure within a week or two.