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NEW HAVEN, Conn., July 12 /PRNewswire/ -- Genaissance Pharmaceuticals, Inc. (Nasdaq: GNSC - news), today announced that it has published in the international journal, ``Science'(1) the most detailed examination of human genes ever conducted. The research demonstrates that there is no one single form of any given gene.
``These results will cause the scientific and medical communities to rethink the definition of the human genome,' said Gualberto Ruano, M.D., Ph.D., CEO of Genaissance. ``We found that there are on average 14 versions of each gene that can be inherited by a human being. This finding is a breakthrough that makes feasible the development of personalized medicine. By being able to define gene versions, we can now determine those versions that predict drug response and, hence, change the current drug paradigm that one drug fits all individuals.'
In this study of 313 genes in 82 unrelated individuals, Genaissance researchers found a massive amount of previously undiscovered gene variability. Significantly, Genaissance researchers were able to identify the relationship between DNA variation and the different versions of a gene, defined by its haplotype, that exist in the human population. Haplotypes -- akin to genomic bar codes -- represent the pattern and organization of DNA variability that each individual inherits.
``This is the most extensive study of gene variation in diverse populations,' said J. Claiborne Stephens, Ph.D., Executive Director of Population Genomics at Genaissance, and the paper's lead author. ``In essence, we have defined a technology for discovering the gene versions that exist in humans.'
Haplotypes -- A Catalog of the Versions of Genes
Genaissance has pioneered the industrialization of haplotype discovery over the past four years. Recently, major government and academic genome researchers have agreed that haplotypes are a powerful tool to reduce the complexity of genetic information to a practical form from which inferences about human health can be made using small sample sizes.
Genaissance has already discovered over 60,000 gene versions (haplotypes) from nearly 4,000 genes. If there are only 30,000 human genes, then the human genome can now be viewed to consist of about 500,000 gene versions. Genaissance intends to discover the gene versions for all human genes.
``Our work is being conducted on a scale never before achieved,' said Gerald F. Vovis, Ph.D., Chief Technology Officer and Senior Vice President. ``Genaissance was the first to pioneer the approach of using haplotypes as predictors of drug response and, with our proprietary HAP(TM) Technology, has the potential to eliminate trial and error medicine.'
Clinical Studies Creating Personalized Medicines
Genaissance believes that the safety and side effect profile of a drug in any particular individual depends largely on the versions of genes that each person has inherited. Genaissance has already demonstrated that a response to a drug can be predicted from an individual's own DNA using its proprietary HAP(TM) Technology. The findings were published last September in the ``Proceedings of the National Academy of Sciences'(2). Clear correlations were observed between specific haplotypes and clinical response to albuterol, a drug commonly used to achieve rapid improvement in respiratory function.
Building upon the success of the asthma study, Genaissance launched the largest prospective clinical trial ever conducted to discover how physicians can personalize prescriptions using information about human gene variation. The STRENGTH (Statin Response Examined by Genetic HAP(TM) Markers) Study started in April 2001 and patient enrollment into the study is nearly completed. Genaissance plans to initiate other studies over the next year with leading drugs in major therapeutic categories, including asthma and schizophrenia.
``Genaissance is the only company conducting clinical trials using newly discovered versions of genes that are predictive of drug response and side effects,' said Kenneth Kashkin, M.D., Chief Medical Officer and Executive Vice President.
Dr. Ruano concluded, ``Genaissance's clinical studies will help to produce new medicines with demonstrable safety and efficacy advantages over currently available products. This creates an enormous business opportunity for us as we work to improve the health of patients.'

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