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Globavir Biosciences, Inc. Seeking Approval and Launch of Novel Ebola Treatment Before Year End



8/19/2014 7:24:25 AM

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LOS ALTOS, Calif., Aug. 18, 2014 /PRNewswire/ -- 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.

Globavir Biosciences, Inc.

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.

About Ebola

Infection with the Ebola virus causes severe hemorrhagic fever and causes death in up to 90% of cases.  Ebola virus is a member of the family of RNA viruses known as Filoviridae.  Ebola transmission occurs through contact with bodily fluid of an infected patient and there is no currently available treatment for Ebola beyond supportive care. 

Globavir's lead therapeutic program has focused on the treatment of Dengue Fever, which is caused by Flaviviridae, another family of RNA viruses.  Both Ebola and Dengue Fever can cause a syndrome known as viral hemorrhagic fever, a severe illness associated with bleeding.  

A recent outbreak of Ebola in West Africa has killed over 1000 people, and is the largest outbreak recorded. 

About Globavir

Globavir Biosciences is an infectious disease company developing life-saving technologies for the diagnosis and treatment of some of the world's most deadly viral diseases.  Globavir is developing powerful combination drug therapies and diagnostic tests for the treatment of Dengue Fever, and is advancing a development candidate for the treatment of Ebola, GBV006.  Globavir is based out of Mountain View, California, USA, and has additional research facilities in Halifax, Nova Scotia, Canada operating as BioCycive Canada.

Globavir's diagnostic tests and test kits are ready to be marketed globally. The company has the leading blood-based molecular diagnostic test to detect Dengue infection as well as a platform for other viral detection tests.

Forward Looking Statements and Information

In order to provide Globavir's investors with an understanding of its current results and future prospects, this press release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward looking statements. Words such as "believes," "anticipates," "hopes," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements about the development of Globavir's product candidates, their efficacy, potency and utility in the treatment of rare and infectious diseases, their potential to treat a broad number of human diseases and Globavir's studies. These forward-looking statements involve risks and uncertainties, many of which are beyond Globavir's control. Known risk factors include, among others: clinical trials may not demonstrate safety and efficacy of any of Globavir's drug candidates and/or Globavir's technology platform; and any of Globavir's drug candidates may fail in development, may not receive required regulatory approvals, or be delayed to a point where they do not become commercially viable. Any of the foregoing risks could materially and adversely affect Globavir's business results.

Globavir does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

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SOURCE Globavir Biosciences, Inc.

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