Press Release: FDA Grants Orphan Drug Designation for PVSRIPO for the Treatment of Advanced Melanoma
Istari Oncology Announces FDA Grants Orphan Drug Designation for PVSRIPO for the Treatment of Advanced…
From the office of University Hospitals Seidman Cancer Center:
Earlier this year, UH Seidman Cancer Center became one of just six sites participating in a Phase II clinical trial to test the safety and efficacy of oncolytic polio/rhinovirus recombinant (PVSRIPO), a modified polio vaccine-based viral immunotherapeutic, in patients with recurrent malignant glioblastoma (rGBM) (NCT02986178).
The first-in-man Phase I trial, conducted at the Preston Robert Tisch Brain Tumor Center at Duke University Medical Center, showed encouraging results. The study found that survival rates were significantly higher in rGBM patients who received an intratumoral infusion of PVSRIPO immunotherapy compared to similar patients receiving standard treatment at the same institution. Overall survival among patients who received PVSRIPO plateaued at 21 percent at 24 to 36 months and appeared to last for up to five years based on a publication of the interim trial results (Desjardins, et al., 2018 NEJM). The overall survival rate was sustained at 36 months in these patients.
“We’ve never seen survival rates like this before,” says Andrew E. Sloan, MD, FACS, Director of the Brain Tumor & Neuro-Oncology Center and the Center of Excellence in Translational Neuro-Oncology at UH Seidman Cancer Center and UH Neurological Institute, and Professor and Vice Chairman, Department of Neurosurgery at Case Western Reserve University School of Medicine, who serves as principal investigator for the trial. “The long-term survival rate is very exciting. We are proud that University Hospitals was selected as one of a handful of top brain tumor centers, including the Stephen E. and Catherine Pappas Center for Neuro-Oncology at Massachusetts General Hospital and UCSF Brain Tumor Center, to participate in the Phase II clinical trial based on our expertise in immunotherapy and reputation for treating brain tumors.”