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Updated: Feb 22, 2026
Paramyxoviruses for Tumor-targeted Immunomodulation: Design and Evaluation Ex Vivo
Published on: January 7, 2019
Oncolytic H-1 Parvovirus Shows Safety and Signs of Immunogenic Activity in a First Phase I/IIa Glioblastoma Trial
Karsten Geletneky1, Jacek Hajda2, Assia L Angelova3
1Department of Neurosurgery, University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany.
Abstract:
Oncolytic virotherapy may be a means of improving the dismal prognosis of malignant brain tumors. The rat H-1 parvovirus (H-1PV) suppresses tumors in preclinical glioma models, through both direct oncolysis and stimulation of anticancer immune responses. This was the basis of ParvOryx01, the first phase I/IIa clinical trial of an oncolytic parvovirus in recurrent glioblastoma patients. H-1PV (escalating dose) was administered via intratumoral or intravenous injection. Tumors were resected 9 days after treatment, and virus was re-administered around the resection cavity. Primary endpoints were safety and tolerability, virus distribution, and maximum tolerated dose (MTD). Progression-free and overall survival and levels of viral and immunological markers in the tumor and peripheral blood were also investigated. H-1PV treatment was safe and well tolerated, and no MTD was reached. The virus could cross the blood-brain/tumor barrier and spread widely through the tumor. It showed favorable pharmacokinetics, induced antibody formation in a dose-dependent manner, and triggered specific T cell responses. Markers of virus replication, microglia/macrophage activation, and cytotoxic T cell infiltration were detected in infected tumors, suggesting that H-1PV may trigger an immunogenic stimulus. Median survival was extended in comparison with recent meta-analyses. Altogether, ParvOryx01 results provide an impetus for further H-1PV clinical development.
Insights
The first clinical trial of oncolytic H-1 parvovirus (H-1PV) in glioblastoma patients demonstrated safety and tolerability. H-1PV showed promising signs of anti-tumor activity and immune stimulation, warranting further investigation.
Area of Science:
- Oncology
- Virology
- Immunology
Background:
- Malignant brain tumors, particularly glioblastoma, have a poor prognosis.
- Oncolytic virotherapy offers a potential strategy to improve treatment outcomes.
- Rat H-1 parvovirus (H-1PV) has shown preclinical efficacy in glioma models.
Purpose of the Study:
- To evaluate the safety and tolerability of H-1PV in patients with recurrent glioblastoma.
- To determine the maximum tolerated dose (MTD) of H-1PV.
- To assess virus distribution, pharmacokinetics, and immunogenicity.
Main Methods:
- ParvOryx01: a phase I/IIa clinical trial involving escalating doses of H-1PV.
- Administration via intratumoral or intravenous injection, with tumor resection and re-administration.
- Monitoring of safety, tolerability, virus distribution, survival, and immunological markers.
Main Results:
- H-1PV was safe and well tolerated; MTD was not reached.
- The virus crossed the blood-brain/tumor barrier and spread within the tumor.
- Dose-dependent antibody formation and T-cell responses were observed, with markers of immune activation in tumors.
Conclusions:
- H-1PV is a safe and well-tolerated oncolytic virus for glioblastoma.
- H-1PV demonstrates potential for anti-tumor activity and immune stimulation.
- Results support further clinical development of H-1PV for brain tumor treatment.
