NSAID Safety Biomarkers

Co-SAVE Project: Companion Safety for Adverse cardioVascular Events

The main objective of the Co-SAVE project is the development of a companion assay for anti-inflammatory drugs, in particular coxibs (cyclooxygenase-2 inhibitors). Indeed anti-inflammatory drugs are used to treat many diseases such as osteoarthritis, rheumatoid arthritis and chronic pain. Despite their efficiency, they may induce severe cardiovascular side effects that could lead to the death of patients. The companion assay will enable identification of patients in which these drugs could induce adverse events and thus allow a safer use of these compounds.

The companion assay will be based on a panel of biomarkers that are measured in blood and whose level will predict cardiovascular toxicity of anti-inflammatory drugs. Firalis has already identified some biomarkers of cardiovascular injuries induced by such drugs in monkeys.

The Co-SAVE project, coordinated by Firalis SAS is performed in close collaboration with UMR645 (which involves Franche-Comté University, INSERM and EFS (French Blood Establishment, Prof. Borg, Besançon). Both partners have been involved in selection of biomarkers and development of specific assays to measure them. Two academic partners are also implicated in the project providing patients samples to test these biomarkers: UMR-CNRS 7211 (Laboratory of immunology, immunopathology, immunotherapeutic, Pierre and Marie Curie University, Prof. Cacoub, Paris) and Tel-Aviv Souraski Medical Center (TASMC, Prof. Nadir ARBER Tel Aviv, Israel).

This project has been acknowledged by the Alsace BioValley Competitiveness Cluster in the field of “therapeutic innovations” and within the theme “from chemistry and genes to drugs” on April 28th 2010.

This project will allow qualifying Firalis proprietary biomarkers into human clinics. The assays developed under this project will be produced and marketed by Firalis. It will enable to exploit and economically develop the patent, held by the company.