Orion Pharma has been signed up as one of the first customers for the new DME (drug metabolism enzyme) test from Jurilab Ltd. The DME microarray-based genetic test will provide essential data in a Phase I clinical trial.
Different people metabolize drugs at varying rates, due to individual differences in the levels and activities of drug metabolism enzymes. Clinical trials need to take this into account in order to minimize potential drug side effects or adverse drug reactions (ADRs). Jurilab's DME microarray-based genetic test has been designed for use in screening candidates for clinical trials by genotyping, as well as in explaining potential deviations in response to the drug. The microarray includes naturally occurring genetic variations or single nucleotide polymorphisms (SNPs) from eight different DMEs, most of which are associated with reduced, or a complete lack of, enzyme activity. The test also allows for detection of deletion or duplication of certain DME genes. The resultant DME genetic profile provides invaluable data to assist with interpretation of trial results and potentially on the criteria for target patient groups after the drug is launched.
Marjut Ranki-Pesonen, assistant vice president, Clinical Development, Pharmacogenomics and New Technologies, Orion Pharma, commented, "We are confident that the use of pharmacogenetic profiling of the volunteers in this particular trial will make a genuine difference. The content is broader than other DME test options currently available, and there is the added advantage that we do not need to invest in additional equipment for use with the DME microarray. The information received from the test will allow us to explain why some subjects have exceptionally high or low concentration of the drug in their plasma. This information may be critical when deciding the optimal therapeutic dose."
Nora Kaarela, vice president, Business Development, Jurilab, added, "We are delighted that Orion Pharma have decided to use our DME test and believe that the genotyping it affords will help ensure the highest possible level of drug safety and efficacy. Ultimately, it will also help keep down rising clinical trial costs."
Jurilab provides validated gene-based therapeutic and diagnostic targets for common and complex human diseases. The company has exclusive access to the world's most comprehensive DNA and data bank, derived from the Eastern Finnish founder population. Together with a proprietary sequencing method, HPTS, this population allows the company to carry out gene discovery research on a significantly lower number of samples than is possible using other populations. Jurilab develops these validated targets into gene-based predictive tests through in-house programs and via collaborations with in vitro diagnostics and pharmaceutical companies.
About Orion Corporation Orion Pharma
Orion Pharma is a research and development-orientated pharmaceutical division of the Orion Group (HEX:ORIA, ORIB), which is one of the leading companies in the Nordic healthcare sector. Pharmaceutical R&D at Orion Pharma focuses on CNS therapies, cardiology and critical care, and hormonal therapies. Entacapone, a COMT enzyme inhibitor used in the treatment of Parkinson's disease, is Orion Pharma's patented molecule discovery, available globally as Comtess and Comtan. In June 2003, Orion Pharma received the Marketing Authorization from FDA for Stalevo, a new treatment of PD, which combines levodopa and carbidopa with entacapone in one tablet.
For more information, visit http://www.orion.fi or http://www.orionpharma.com or http://www.jurilab.com.
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