Clinical Trials

Oncolytics Biotech is conducting clinical trials in multiple indications with the objective of developing REOLYSIN® as a human cancer therapeutic. The current clinical program comprises human trials using REOLYSIN® both alone and in combination with chemotherapy, delivered via local and/or intravenous administration. In May 2010, the Company commenced enrollment for its first Phase III clinical trial, REO 018, investigating the intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers.

Trial Number Phase Trial Name Location Status
NCI-9603 (NCI Trial) Translational Study Intravenous Administration of REOLYSIN® in Combination with Dexamethasone and Carfilzomib for Patients with Relapsed or Refractory Myeloma US Ongoing
IND 213 (NCIC CTG Trial) Phase II Intravenous Administration of REOLYSIN® in Combination with Paclitaxel for Patients with Advanced or Metastatic Breast Cancer Canada Ongoing
IND 211 (NCIC CTG Trial) Phase II Intravenous Administration of REOLYSIN® in Combination with Docetaxel or Pemetrexed for Patients with Previously-Treated Advanced or Metastatic Non-Small Cell Lung Cancer Canada Ongoing
IND 210 (NCIC CTG Trial) Phase II Intravenous Administration of REOLYSIN® in Combination with FOLFOX-6 Plus Bevacizumab (Avastin®) Versus FOLFOX-6 Plus Bevacizumab Alone in Patients with Advanced or Metastatic Colorectal Cancer Canada Ongoing
IND 209 (NCIC CTG Trial) Phase II Intravenous Administration of REOLYSIN® in Combination with Docetaxel for Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer Canada Ongoing
OSU-11148 (NCI Trial) Phase I Intravenous Administration of REOLYSIN® for Patients with Relapsed Multiple Myeloma  US Ongoing
NCI-8601/OSU-10045 (NCI Trial) Phase II Intravenous Administration of REOLYSIN® in Combination with Paclitaxel and Carboplatin for Patients with Metastatic Pancreatic Cancer US Ongoing
COG-ADVL1014 (NCI / COG Trial) Phase I Intravenous Administration of REOLYSIN® in Combination with Cyclophosphamide for Pediatric Patients with Relapsed or Refractory Solid Tumors US Ongoing
GOG-0186H (NCI / GOG Trial) Phase II Intravenous Administration of REOLYSIN® in Combination with Paclitaxel for Patients with Persistent or Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer US Ongoing
REO 022 Phase I Intravenous Administration of REOLYSIN® in Combination with FOLFIRI and Bevacizumab in FOLFIRI naive Patients with Mutant Metastatic Colorectal Cancer US Ongoing
REO 021 Phase II Intravenous Administration of REOLYSIN® in Combination with Paclitaxel and Carboplatin for Patients with Squamous Cell Carcinoma Lung Cancer US Ongoing
REO 020 Phase II Intravenous Administration of REOLYSIN® in Combination with Paclitaxel and Carboplatin for Patients with Metastatic Melanoma US Ongoing
REO 018 Phase III Intravenous Administration of REOLYSIN® in Combination with Paclitaxel and Carboplatin for Patients with Platinum-Refractory Head and Neck Cancers International Complete
REO 017 Phase II Intravenous Administration of REOLYSIN® in Combination with Gemcitabine for Patients with Advanced Pancreatic Cancer US Ongoing
REO 016 Phase II Intravenous Administration of REOLYSIN® in Combination with Paclitaxel and Carboplatin for Patients with Non-Small Cell Lung Cancer US Ongoing
REO 015 Phase II Intravenous Administration of REOLYSIN® in Combination with Paclitaxel and Carboplatin for Patients with Advanced Head and Neck Cancers US Complete
REO 014 Phase II Intravenous Administration of REOLYSIN® for Patients with Metastatic Sarcomas US Complete
REO 013 Brain Phase I Intravenous Administration of REOLYSIN® in Patients Prior to Surgical Resection of Recurrent High Grade Primary or Metastatic Brain Tumors UK Ongoing
REO 013 Translational Study Intravenous Administration of REOLYSIN® for Patients with Metastatic Colorectal Cancer UK Complete
MAYO-MC0672 (NCI Trial) Phase II Intravenous Administration of REOLYSIN® for Patients with Metastatic Melanoma  US Complete
OSU-07022 (NCI Trial) Phase I/II Systemic and Intraperitoneal Administration of REOLYSIN® for Patients with Metastatic Ovarian, Peritoneal and Fallopian Tube Cancers  US Ongoing
REO 012 Phase I Intravenous Administration of REOLYSIN® in Combination with Cyclophosphamide for Patients with Advanced Malignancies UK Ongoing
REO 011 Phase I/II Intravenous Administration of REOLYSIN® in Combination with Paclitaxel and Carboplatin for Patients with Advanced Head and Neck Cancers UK Complete
REO 010 Phase I Intravenous Administration of REOLYSIN® in Combination with Docetaxel for Patients with Advanced Malignancies UK Complete
REO 009 Phase I Intravenous Administration of REOLYSIN® in Combination with Gemcitabine for Patients with Advanced Malignancies UK Complete
REO 008 Phase II Intratumoral Administration of REOLYSIN® in Combination with Low-Dose Radiation for Patients with Advanced Malignancies UK Complete
REO 007 Phase I/II Infusion Monotherapy of REOLYSIN® for Patients with Recurrent Malignant Gliomas  US Complete
REO 006 Phase I Local Administration of REOLYSIN® in Combination with Radiation for Patients with Advanced Cancers UK Complete
REO 005 Phase I Systemic Administration of REOLYSIN® for Patients with Various Metastatic Tumors  UK Complete
REO 004 Phase I Systemic Administration of REOLYSIN® for Patients with Various Metastatic Tumors US Complete
REO 003 Phase I/II Local Monotherapy of REOLYSIN® for Patients with Recurrent Malignant Gliomas  Canada Complete
REO 002 Translational Study Local Monotherapy of REOLYSIN® for Patients with T2 Prostate Cancer Canada Complete
REO 001 Phase I Local Monotherapy of REOLYSIN® for Patients with Subcutaneous Tumors Canada Complete

REOLYSIN® is currently available exclusively in a clinical trial setting. It has not been approved in any jurisdiction and is not available for purchase. Oncolytics and its clinical partners are conducting clinical trials in a number of countries worldwide, including Canada, the United States and the United Kingdom.

The Company and its employees have no influence upon the inclusion of a patient in a clinical trial. If the patient’s physician determines that he or she may be a suitable trial candidate, they can contact a participating center. Contact information, as well as inclusion and exclusion criteria, for US and international participating centers, can be found at www.clinicaltrials.gov for studies with a US component.

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