IND approval for Phase I clinical trials in the US　 New epigenetic targeting cancer drug OBP-801

NEWS RELEASE December 22, 2014 Oncolys BioPharma Inc. TSE Mothers: 4588 IND approval for Phase I clinical trials in the US – New epigenetic targeting cancer drug, OBP-801 – Oncolys BioPharma Inc. (Oncolys) receives IND (Investigational New Drug) approval for the Phase 1 clinical study on OBP-801, novel epig enetic cancer drug from the US FDA (Food and Drug Administration), which IND application has been filed on November 21st, 2014. Oncolys obtained worldwide exclusive license on OBP-801 in October 2009 from Astellas Pharma Inc. and have conducted pre-clinical studies including CMC development necessary for IND filing. Oncolys have been preparing its First in Human trial in the US. There is no financial impact associated with this announcement. About OBP-801 OBP-801 is a cyclic depsipeptide which is produced by fermentation of Pseudomonas fluorescens strain. Oncolys has been developi ng OBP-801 in order to target “Epigenetic alterations” in the genome of cancer cells. In addition to familial or somatic mutations, epigenetic alterations have critical role in cancer development. Epigenetic alterations shut down the expression of “tumor suppressor genes”, and th is in turn progresses cancer development. OBP-801 is HDAC inhibitor and HDAC is one of the best known epigenetic modulators. Inhibition of HDACs results in cancellation of epig enetic alterations to turn on various tumor suppressor genes. Contact Namiko Yamashita, Ph.D. Manager, Licensing Department [email protected]

The release as fetched from its publisher. oncolys.com ↗