Genaissance announces initial STRENGTH findings

Researchers at Genaissance Pharmaceuticals have found "statistically significant" associations between genetic markers and certain patient responses to cholesterol-lowering drugs. Such associations, or links, could be used to develop pharmacogenomic tests that would help physicians determine the best drug for a particular patient.

"Number one, it validates what we are doing, and that we can identify these variations that predict response to therapeutic agents," says Carol Reed, executive director of medical affairs at Genaissance. "Secondly, the associations are significant."

"Genaissance does not sell any of these drugs, and they are the most successful category of drugs in pharmaceutical history," says Peter Tollman of The Boston Consulting Group. "If these associations are significant enough, this could create a very interesting dynamic."

These results come from an initial analysis of the company's STRENGTH (STatin Response ExamiNed by GeneTic HAP Markers) study, which involves simvastatin (Merck & Co's Zocor), atorvastatin (Pfizer's Lipitor), and pravastatin (Bristol-Myers Squibb's Pravachol). The company was looking for links between specific genetic markers and changes in the levels of LDL (bad) cholesterol and HDL (good) cholesterol and triglycerides in patients taking statins.

Individuals can vary widely in how they respond to cholesterol-lowering drugs. Major goals of therapy are to reduce the amount of bad cholesterol and to improve the ratio of good cholesterol to bad.

Genaissance uses sequencing to find genetic variations called single nucleotide polymorphisms (SNPs). The company then applies its proprietary algorithms to assign these variations to particular sets, called haplotypes. Certain haplotypes are heritable and may be linked to characteristics such as disease susceptibility or drug response. Studying haplotypes, rather than individual SNPs, is considered a more powerful way to do population genetics studies, because fewer patients are necessary. Genaissance has compiled a database of more than 5,000 such haplotypes, which the company calls HAP markers. Its aim is to determine if any of these are "red flags" for particular drug responses. The company has also identified 100 genes that may be linked to patient response to statins.

Genaissance does not manufacture or sell any of the drugs in the STRENGTH study. The company plans to develop tests that predict response to major classes of medicines. "If something meaningful comes out of the Genaissance study, we will see a whole new set of competitors going after the big pharma drugs, and a need to respond by big pharma," says Tollman.

But he and others advise caution. "The study is small," says Tollman. The trial covers three drugs, and about 150 patients each received one particular type of statin. Overall, more than 500 patients were enrolled. Also, the study results have not yet been published or presented.

"We did the press release to let the clinical world and the investor world know that the study is complete, that we are analyzing the data, and that there is interesting data there," says Reed. The company plans to publish and present findings from the study throughout the year.

"The study was big enough for us to derive statistically relevant correlations," says Reed. "We expect to derive commercial value from these associations."