Trial Profile
REO13 Brain: A clinical study to evaluate the biological effects of preoperative intravenous administration of wild-type reovirus (REOLYSIN®) in patients prior to surgical resection of recurrent high grade primary or metastatic brain tumours.
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 07 Mar 2019
Price :
$35
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At a glance
- Drugs Pelareorep (Primary)
- Indications Brain cancer; Brain metastases; Glioblastoma
- Focus Pharmacodynamics
- Acronyms REO013b
- 01 Sep 2015 Status changed from recruiting to completed as reported by ISRCTN: Current Controlled Trials record.
- 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.
- 15 Apr 2015 Data from this study was presented at the Royal Society of Medicine's Immuno-oncology: Using the Body's Own Weapons conference, according to an Oncolytics Biotech media release.