One way for them to get something out of the FDA ?
OXFORD, England, Sept. 19 /PRNewswire-FirstCall/ -- Oxford GlycoSciences Plc (LSE: OGS - News; Nasdaq: OGSI - News) today announced that it has entered a Cooperative Research and Development Agreement (CRADA) with the Center for Drug Evaluation and Research of the US Food and Drug Administration (FDA). The research collaboration will aim to identify serum protein biomarkers that could be useful across species during drug development for early prediction and evaluation of drug-induced toxicities to minimize risk of serious adverse events in clinical trials as well as after drug approval.
Under the terms of the CRADA, titled "Development of Improved Biomarkers for Early Detection of Myocardial Injury, Vascular Injury, and Liver Injury", FDA researchers will initiate a programme to develop specific models of drug-induced histopathologic injury to the myocardium, the vasculature, and the liver and will produce biological samples suitable for proteomics analysis. The investigators at OGS will use industrial scale proteomics technology to analyse those samples and identify serum markers indicative of specific toxic responses.
David Ebsworth, Ph.D., Chief Executive Officer of OGS, commented: "Drug-induced toxicity is an increasing concern of regulatory authorities and the pharmaceutical industry in general. For example, drug-induced damage to the liver is the most common type of toxicity that results in a treatment being withdrawn from clinical trials or from further marketing. Similarly, cardiotoxicity is a frequent occurrence in patients undergoing cancer chemotherapy. However, the currently available biomarkers for these common types of drug-induced toxicities have limited sensitivity or predictive value."
He added: "We believe that this research collaboration with the FDA offers great potential for discovering better biomarkers that may have a significant impact on the research and development of safer drugs."
Frank Sistare, Ph.D., Director of the Division of Applied Pharmacology Research at the Center for Drug Evaluation and Research at the FDA, commented: "We have been relying on the same set of clinical chemistry endpoints for routine animal toxicity testing and clinical trial safety monitoring for over 25 years. The proteomic tools available today are empowering us to tap into the wealth of genome sequence information to discover and carefully investigate associations of thousands of proteins with drug-induced toxicities that are now not easily monitored."... |
