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Game-Changing Animal Research Models Offer Superior Translational Research and Better Predictive Efficacy

SIOUX CENTER, Iowa, April 27, 2016 /PRNewswire/ -- Exemplar Genetics, a wholly owned subsidiary of Intrexon Corporation XON, -3.20% committed to enabling the study of life-threatening human diseases, today announced the U.S. Food & Drug Administration (FDA) has exercised enforcement discretion in regard to the ExeGen [®] low-density lipoprotein receptor (LDLR) miniswine clearing it for commercial use as a research model.

As the first genetically engineered (GE) miniswine model reviewed and cleared by the FDA, Exemplar's powerful investigational platform can now be offered to researchers and drug developers helping forge a more reliable, consistent path from pre-clinical testing through human studies. The ExeGen [®] LDLR model is a game-changer that enables superior translational research and better predictive efficacy in the generation of novel gene- and cell-based therapies, small molecules, as well as biologics for cardiac disease.

"Current animal research models are useful yet not predictive, and the results they generate pre-clinically often do not translate into the clinic," said John R. Swart, Ph.D., President and Chief Executive Officer of Exemplar Genetics. "We thank the FDA for their comprehensive four-year review and decision which empowers researchers and drug developers focused on cardiovascular disease with the potential for greater drug and device discovery. This is an important milestone in the drug development industry."

Animal models that fail to sufficiently represent human pathologies create a significant barrier to understanding disease mechanisms, as well as hinder the development of efficacious therapeutics and novel diagnostics and devices. Since the late 1980's GE mice have been a mainstay of biomedical research and today...