Clinical Data secures European patent for key multi-drug resistance gene

Clinical Data, Inc. has announced that the European Patent Office has granted Patent No. 1232260 to Bernried, Germany-based Epidauros Biotechnologie AG, a wholly-owned subsidiary of Clinical Data, relating to the use of a genetic variant, or biomarker, of the gene MDR1 (also known as ABCB1), which encodes P-glycoprotein (PGP).

PGP is an efflux pump expressed in the gut and kidneys but also by tumor cells, and therefore modulates the response to medications by blocking their absorption into the body or into tumors. Classes of drugs transported by PGP include chemotherapeutics, immunosuppressants, and protease inhibitors.

Genetic testing of MDR1 variation has become an increasingly important part of many drug discovery and development efforts. The particular variant covered by the patent issued to Epidauros, C3435T, is the most common variant of MDR1, occurring in approximately 50% of Caucasians and in 20% and 40% of people of African and Asian descent, respectively. C3435T is part of the newly launched Affymetrix Drug Metabolizing Enzymes and Transporter (DMET) Early Access solution, currently the world's most comprehensive method for assaying the genetics of drug metabolism. Clinical Data´s Cogenics® division supported Affymetrix in its development and commercialization of this technology.

"With the acquisition of Epidauros in August 2007, Clinical Data's PGxHealth® division gained a rich portfolio of genetic biomarkers for drug metabolism and transport, and we have made significant progress in unlocking its value," said Drew Fromkin, President and CEO of Clinical Data. "The issuance of this European patent for MDR1 and its use as part of a new standardized panel for routine pharmacokinetic analysis are important milestones in this effort. We are actively pursuing opportunities to develop predictive tests for drug response with this proprietary MDR1 variant as additional data further validate its clinical utility in a number of therapeutic indications."

The European Patent Office also recently granted Patent No. 135835 to Epidauros which relates to the detection of the *7 allele of the CYP3A5 gene. CYP3A5 regulates an enzyme known to metabolize many common, frequently prescribed drugs -- including statins, calcium channel blockers, and HIV protease inhibitors. The *7 allele is most commonly found in people of African descent, where the frequency of *7 is as high as 20%.