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Please Note: The technology listed below is not available to the public at this time. This technology requires further development before it is ready for the marketplace. The VA is currently in the process of identifying potential companies who may be interested to commercially develop the technology. The VA inventors are available to collaborate with interested companies through a Cooperative Research and Development Agreement (CRADA). Through cooperative research initiatives such as these, it is our hope and goal that commercial products will be fully developed and made available to benefit veterans and others.
VA TECHNOLOGY OPPORTUNITY BRIEF
Statin Treatments for Viral Diseases
(VA 07-018)
OPPORTUNITY
The Department of Veterans Affairs (VA) is seeking a commercial partner to further develop and commercialize the use of statins alone or in combination with pegylated interferon and ribavirin for the treatment of hepatitis C (HCV) and other viral diseases.
TECHNOLOGY BACKGROUND AND DESCRIPTION
It has been observed that fluvastatin is a potent inhibitor of viral reproduction in cultured human liver cells. Therefore, it was hypothesized that statins, either alone or in combination with standard HCV therapy may provide an improved treatment for HCV disease. A retrospective analysis of 400 HCV patients undergoing standard pegylated interferon plus ribavirin (PI+R) therapy revealed that those receiving a statin in addition to the standard PI+R therapy had a cure rate of 63%, compared to a cure rate of 37% for standard therapy alone.
This observation led to an FDA IND license to determine a safe and effective dosing schedule with fluvastatin (FLV) as a monotherapy. The trial study concluded that FLV is safe for use in patients chronically infected with HCV. The in vivo effects of FLV as a monotherapy are modest, variable, and short lived. These findings, along with the aforementioned retrospective analysis and an in vitro study suggesting synergism with alpha-interferon, provided the rationale for a pilot human study combining FLV with standard PI+R therapy. This study has recently been initiated.
COMPETITIVE ADVANTAGE
The current standard PI+R therapy has a less than 50% cure rate and can result in chemotherapy-like side effects. Therefore, the need for more efficacious therapy options is apparent. The use of statins as an addition to PI+R should facilitate commercialization of this technology since it does not require supplanting current HCV therapeutics. Further, since there is a large population of HCV patients who remain untreated1, drugs that provide increased efficacy should facilitate expansion of the market. With new efficacious treatments for HCV, it is estimated that the world market for chronic HCV treatment could reach $9 billion by 2010.
IP STATUS:
Provisional patent application filed on 10/6/06 (60/849,978)
1 In the United States, only about half the estimated 2.7 million people carrying HCV are diagnosed and only a small number of those (approximately 80,000) receive treatment.
FOR MORE INFORMATION CONTACT:
Saleem Sheredos
Program Manager
Technology Transfer Program
Veterans Affairs
Office of Research & Development (12TT)
5th Floor
103 South Gay Street
Baltimore, MD 21202
202-380-5080
Fax 410.962.2141
e-mail: saleem.sheredos@va.gov
e-mail: saleem.sheredos@va.gov