Table 1.

Summary of clinical trials with reported data. This table summarizes the current data from completed and ongoing clinical trials with Reovirus

Study #IndicationOther therapyNumber of patientsPhaseLowest dose (TCID50)Highest dose (TCID50)Grade 3/4 toxicitiesEfficacyViral detection serum/CSF/stool/urine/fecesAntibody responseReferenceComments
Intratumoral
 1Solid tumors181107 (PFU)1010 (PFU)None1 CR, 1 PR, 8 SDSerumYes33
 2Prostate6Pilot107 (PFU)None1 PR, 4 SDUrineYes34
 3Malignant gliomas1211 × 1071 × 109Transient GGT elevation1 SDSaliva, FecesYes
 6Solid tumorsXRT 20–36 Gy2311 × 1081 × 1010None7 PR, 7 SDNoneYes39
 7Malignant gliomas151/21 × 1081 × 1010NRNRNRNR
 8Solid tumorsXRT-20 Gy1621 × 1010None4 PR, 2 MR, 7 SDNRYes40
Intravenous
 4Solid tumors1811 × 1083 × 1010None1 PR, 7 SDUrine, Serum, Saliva, FecesYes41
 5Solid tumors3311 × 1083 × 1010Flu-like syndrome3 MR, 7 SDUrine, Serum, Saliva, FecesYes44
CPK-MB/Trop I elevation
Lymphopenia
Neutropenia
 9Solid tumorsGemcitabine 1000 mg/m21211 × 1093 × 1010Flu-like syndrome48
Neutropenia
AST/ALT/GGT elevation
Trop I elevaton/ST changes
 10Solid tumorsDocetaxel 75 mg/m22411 × 1093 × 1010Febrile neutropenia4 PR, 3 MR, 7 SDUrine, Serum, Saliva, FecesYes54
Thrombocytopenia
GI symptoms
Hypokalemia
HypotensionNRNR
 11Solid tumorsCarboplatin AUC 5311/23 × 1093 × 1010Myelosuppression8 PR, 6 SD56Efficacy data among 19 patients with Head and Neck Cancer
Paclitaxel 175 mg/m2Hypotension
 13Colorectal cancer with liver metastases1021 × 1010Yes16Virus selectively detected in cancerous liver tissue
 14Sarcomas5323 × 1010Neutropenia19 SDNRNR
Optic neuritis
 15Head and neck cancerCarboplatin AUC 51423 × 1010Neutropenia4 PR, 2 SDNRNR57
Paclitaxel 175 mg/m2Hypokalemia
Fatigue
Anemia
Nausea
Hypotension
 16NSCLCCarboplatin AUC 62223 × 1010Myelosuppression6 PR, 13 SDNRNR58
Paclitaxel 200 mg/m2Hypotension
Fatigue
GI symptoms
 17Pancreatic cancerGemcitabine 800 mg/m21823 × 1010Neutropenia1 unconfirmed PRNRNR52
7 SD

NOTE: The study # preceded by “REO” indicates the number assigned by the study sponsor, namely Oncolytics, to enable an easy search for the reader. While some trials are mature and full reports have been published, others are ongoing with preliminary data presented at international and national meetings or updated on the company's website. The table provides a quick overview with focus on the study design, patient accrual numbers, dosing, immunology, toxicities, and efficacy, and comments about the uniqueness of the conduct or the results of the study.

Abbreviations: AUC: area under the concentration time curve; XRT: radiation; MR: minimal response; NR: not reported; PFU: particle forming units.