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Personalized Medicine Approach To Assessing Cancer Prevention Properties Of Statins

Background:
The National Cancer Institute's Chemopreventive Agent Development Research Group is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize methods to assess reduction of cancer risk associated with statin treatment.

Technology:
Statins are a class of well-tolerated compounds that are the most widely used cholesterol-lowering drugs in the United States. Reduced risk of colorectal cancer (CRC) among statin users has been observed as a secondary outcome in clinical trials evaluating effects of statins on cardiovascular outcomes. Because these results have been variable between clinical trials, there is a need for methods to identify patients that will benefit from statins in terms of reduction of cancer risk.

The current invention describes pharmacogenetic methods to identify candidates who are most likely to benefit from treatment with statins to reduce cancer risk, and consequently to avoid any unnecessary cost and side effects in individuals who do not benefit.   We discovered that an HMGCR genetic variant rs12654264 is associated with significantly lower colorectal cancer risk, with most of the benefit seen in HMGCoA reductase inhibitor (statin) users. We also discovered that this same HMGCR genetic variant is associated with significantly higher serum cholesterol levels in Israeli colorectal cancer patients. The same HMGCR genetic variant has also been associated with significantly higher serum cholesterol levels in two independent groups of individuals of mixed European descent (http://www.broad.mit.edu/diabetes/scandinavs/index.html  and NEJM March 20, 2008 1240-1249). These data suggest that the same genetic variant modifies cholesterol metabolism in a manner that affects both colorectal cancer risk and cardiovascular risk.
     
Further R&D Needed: 
Validation of findings in two additional NCI supported case-control studies

R&D Status: Pre-clinical, in vitro proof-of-concept completed.

IP Status:  Pending PCT Application PCT/US2006/022180, published as WO 2006/13316

Value Proposition:

• HMGCR genetic variant is associated with significantly lower colorectal cancer risk, with most of the benefit seen in HMGCoA reductase inhibitor (statin) users
• HMGCR genetic variant is associated with significantly higher serum cholesterol levels in Israeli colorectal cancer patients
• HMGCR genetic variant has also been associated with significantly higher serum cholesterol levels in two independent groups of individuals of mixed European descent (http://www.broad.mit.edu/diabetes/scandinavs/index.html  and NEJM March 20, 2008 1240-1249).
• Possibly the same genetic variant modifies cholesterol metabolism in a manner that affects both colorectal cancer risk and cardiovascular risk.
• May enable a personalized medicine approach to preventing colorectal cancer