Oncolytics Biotech is directing a broad clinical trial program with the objective of developing REOLYSIN® as a human cancer therapeutic. The current clinical program includes human trials using REOLYSIN® alone and in combination with chemotherapy or immune modulation, and delivered via local administration and/or intravenous administration. The Company's first pivotal trial will be a Phase III randomized clinical trial examining the intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with platinum-failed head and neck cancers.
REOLYSIN is available in a clinical trial setting only. It is not approved in any jurisdiction and not available for purchase. The Company does not participate in special access programs. Most of the trials are being conducted in the U.S. by Oncolytics and its clinical partners.
The Company and its employees have no influence over the inclusion of a patient in a clinical trial. To obtain a list of U.S. trials currently being conducted using REOLYSIN please visit www.clinicaltrials.gov and search using the term REOLYSIN. Each listing includes patient inclusion and exclusion criteria. If the patient’s physician determines that they might be a suitable trial candidate, they can contact a participating centre; there is contact information near the bottom of each trial listing.
While the Company does have a broad clinical program, it is increasingly focused on specific indications. Patients that cannot find a trial for their specific indication are invited to check the www.clinicaltrials.gov website periodically as the site is updated as new trials are announced.
| NCI Trial |
Intravenous administration monotherapy |
Phase I relapsed multiple myeloma |
U.S. |
Announced |
| NCI Trial |
Intravenous administration in combination with paclitaxel and carboplatin |
Phase II recurrent or metastatic pancreatic cancer |
U.S. |
Ongoing |
| NCI / COG Trial |
Intravenous administration in combination with cyclophosphamide |
Phase I Pediatric Patients with relapsed or refractory solid tumors |
U.S. |
Announced |
| NCI / GOG Trial |
Intravenous administration in combination with paclitaxel |
Phase II persistent or recurrent ovarian cancer |
U.S |
Ongoing |
| REO 022 |
Intravenous administration in combination with FOLFIRI |
Phase I colorectal cancer |
U.S. |
Ongoing |
| REO 021 |
Intravenous administration in combination with paclitaxel and carboplatin |
Phase II squamous cell carcinoma lung cancer |
U.S. |
Ongoing |
| REO 020 |
Intravenous administration in combination with paclitaxel and carboplatin |
Phase II metastatic melanoma |
U.S. |
Ongoing |
| REO 018 |
Intravenous administration in combination with paclitaxel and carboplatin |
Phase III squamous cell carcinoma of the head and neck |
U.S., U.K., Belgium, Canada |
Ongoing |
| REO 017 |
Intravenous administration in combination with gemcitabine |
Phase II advanced pancreatic cancer |
U.S. |
Ongoing |
| REO 016 |
Intravenous administration in combination with paclitaxel and carboplatin |
Phase II non-small cell lung cancer |
U.S. |
Ongoing |
| REO 015 |
Intravenous administration in combination with paclitaxel and carboplatin |
Phase II head and neck |
U.S. |
Ongoing |
| REO 014 |
Intravenous administration monotherapy |
Phase II sarcomas |
U.S. |
Complete |
| REO 013 |
Intravenous administration monotherapy (sponsored by University of Leeds) |
Translational metastatic colorectal |
U.K. |
Ongoing |
| NCI Trial |
Intravenous administration monotherapy (NCI) |
Phase II melanoma |
U.S. |
Complete |
| NCI Trial |
Intravenous and intraperitoneal administration monotherapy (NCI) |
Phase I/II ovarian |
U.S. |
Ongoing |
| REO 012 |
Intravenous administration in combination with cyclophosphamide |
Advanced malignancies including pancreatic, lung, ovarian |
U.K. |
Ongoing |
REO 011
(Phase II) |
Intravenous administration in combination with paclitaxel and carboplatin |
Phase II head and neck |
U.K. |
Complete |
| REO 011 |
Intravenous administration in combination with paclitaxel and carboplatin |
Advanced malignancies including melanoma, lung, ovarian |
U.K. |
Complete |
| REO 010 |
Intravenous administration in combination with docetaxel |
Advanced malignancies including bladder, prostate, lung, upper gastro-intestinal |
U.K. |
Complete |
| REO 009 |
Intravenous administration in combination with gemcitabine |
Advanced malignancies including pancreatic, lung, ovarian |
U.K. |
Complete |
| REO 008 |
Local therapy in combination with radiation |
Phase II various metastatic tumours, including head & neck |
U.K. |
Complete |
| REO 007 |
Infusion monotherapy |
Phase I/II recurrent malignant gliomas |
U.S. |
Complete |
| REO 006 |
Local therapy in combination with radiation |
Phase I various metastatic tumours |
U.K. |
Complete |
| REO 005 |
Intravenous administration monotherapy |
Phase I various metastatic tumours |
U.K. |
Complete |
| REO 004 |
Intravenous administration monotherapy |
Phase I various metastatic tumours |
U.S. |
Complete |
| REO 003 |
Local monotherapy |
Phase I recurrent malignant gliomas |
Canada |
Complete |
| REO 002 |
Local monotherapy |
T2 prostate cancer |
Canada |
Complete |
| REO 001 |
Local monotherapy |
Phase I trial for various subcutaneous tumours |
Canada |
Complete |