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 and is alive, clinically normal, and is a complete responder.
Istari Oncology initiated a Phase 2 multi-institutional, dose refinement trial in mid-2017 that includes a chemotherapy component found to be beneficial in the Phase 1 study. This clinical trial will involve 62 GBM patients. It should be completed within two to three years and serve as the precursor for a larger multi-institutional registration trial to secure FDA approval.
We are evaluating D2C7-IT in a dose escalation Phase 1 study in 24 recurrent GBM patients. It has been well-tolerated in 16 patients studied so far.
Current Clinical Trials
Phase 1 PVSRIPO for Recurrent GBM: NCT01491893
Phase 1b PVSRIPO in Children with Recurrent Glioma: NCT03043391
Phase 2 PVSRIPO +/- Lomustine: NCT02986178
Phase 1 D2C7-IT for Recurrent Malignant Glioma: NCT02303678
We are planning to conduct Phase 1 trials with PVSRIPO and an anti-PD1 checkpoint inhibitor in GBM and two other cancer indications. Istari Oncology is currently in negotiations with pharmaceutical companies to participate in these trials. We expect to initiate a Phase 1 combination study in melanoma in 2018.