Globavir plans to seek approval, launch novel drug for treatment of Ebola infection

Aug 19 2014

Globavir Biosciences, Inc. ("Globavir"), a biotechnology company developing therapeutics to treat infectious diseases, has announced intentions to develop its lead drug candidate, GBV006, for the treatment of the current Ebola Virus outbreak in West Africa. Globavir will seek approval for the use of GBV006, a combination of Food and Drug Administration (FDA) approved drugs, through an established compassionate use regulatory pathway. The discovery of the use of GBV006 for the treatment of infectious diseases was made at Stanford University School of Medicine (Palo Alto, CA). Globavir has the worldwide exclusive license to develop and market GBV006.

The component drugs of GBV006 have demonstrated efficacy against experimental models of Ebola infection at dosages already approved and well-tolerated by patients. GBV006 is effective at low micromolar concentrations against Ebola in vitro. By relying on thousands of patient years of established safety data, Globavir hopes to rapidly introduce GBV006 as an experimental treatment in helping to control the West Africa outbreak.

"The situation in West Africa is dire, and there is an immediate need for drugs able to reduce the impact of Ebola infection," said Shalabh Gupta, M.D., CEO of Globavir. "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."

Globavir's antiviral therapeutic platform has multiple drugs under development, which were discovered, tested and licensed from Stanford University. The company is evaluating several drug combinations for Ebola treatment.

GBV006 targets and inhibits several distinct stages of the viral lifecycle, including entry of the virus into the cell and maturation of new viruses within cells. These two processes are crucial to viral infections including Ebola, Dengue, and West Nile virus. A distinctive feature of Globavir's technology as compared to other upcoming treatments in the area is that GBV006 targets human cellular machinery necessary for viral replication rather than targeting the viral proteins or DNA directly. As a result, the technology can be utilized to treat diseases caused by different viruses within the same family or those that exploit the same host machinery for entry and replication. A similar approach using GBV001 (a related therapy under development) has shown efficacy in animal models of Dengue virus infection and approval to begin clinical trials will be sought this fall.