A phase I/II clinical trial to evaluate dose limiting toxicity and efficacy of intralesional administration of REOLYSIN [reovirus] for the treatment of patients with histologically confirmed recurrent malignant gliomas
Phase of Trial: Phase I/II
Latest Information Update: 17 Apr 2015
At a glance
- Drugs Pelareorep (Primary)
- Indications Anaplastic astrocytoma; Glioblastoma; Glioma; Gliosarcoma
- Focus Adverse reactions; Therapeutic Use
- Sponsors Oncolytics Biotech
- 17 Apr 2015 According to an Oncolytics Biotech media release, the U.S. Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) for pelareorep [Reolysin], for the treatment of malignant glioma. The Company had applied for an ODD for pediatric high grade gliomas (HGG), however the FDA granted an ODD for the broader indication of malignant glioma in patients of all ages.
- 23 Jun 2010 Actual end date (Jun 2010) added as reported by ClinicalTrials.gov.
- 23 Jun 2010 Status changed from recruiting to completed as reported by ClinicalTrials.gov.