Istari Oncology is committed to developing pathways that lead to the successful clinical development and registration of PVSRIPO and other technologies for the treatment of cancer.
Successful clinical trials are required to gain regulatory approval for new medications to treat and beat cancer.
Following extensive IND-enabling testing, the FDA approved IND 14,735 on June 19, 2011 for Intratumoral Administration of Oncolytic Poliovirus against recurrent GBM. The first patient in the single-center Phase 1 recurrent GBM clinical trial (NCT01491893) was treated May 11, 2012. The FDA granted PVSRIPO breakthrough therapy and Orphan Drug Designation in 2016.