Duke’s Poliovirus Therapy Wins “Breakthrough” Status to Expedite Research

Contact: Sarah AveryPhone: 919-660-1306Email: [e-mail]://www.dukehealth.orgFOR IMMEDIATE RELEASE on Monday, May 16, 2016Duke’s Poliovirus Therapy Wins “Breakthrough” Status to Expedite ResearchDURHAM, N.C. – The recombinant poliovirus therapy developed at the Preston Robert Tisch Brain Tumor Center at Duke Health has been granted “breakthrough therapy designation” from the U.S. Food and Drug Administration.The designation will expedite research into the poliovirus therapy, but it does not mean the investigational drug has been approved for clinical use. It is currently being tested in a clinical trial for adults with advanced glioblastoma brain tumors. To receive breakthrough status, preliminary evidence must indicate that the treatment may offer substantial improvement over available standard therapy.“Breakthrough status means that we can work with the highest levels in the FDA to develop the most efficient clinical trial and pathway to fully evaluate the safety and efficacy of the genetically modified poliovirus for treating recurrent glioblastoma,” said Darell Bigner, M.D., Ph.D., director of the Preston Robert Tisch Brain Tumor Center at Duke. “Ultimately, we hope the therapy will one day obtain FDA approval.” Duke’s poliovirus therapy is an immunotherapy developed in the laboratory of Matthias Gromeier, M.D., a professor in the departments of Neurosurgery, Molecular Genetics and Microbiology, and Medicine at Duke University School o...

Source: DukeHealth.org: Duke Health Features - May 16, 2016 Category: Pediatrics Tags: Duke Medicine Source Type: news