Table 1. Summary of Clinical Trials with reported data.
This table summarizes the current data from completed and ongoing clinical trials with Reovirus. 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.
| Study # | Indication | Other therapy | Number Patients |
Phase | Lowest Dose (TCID50) |
Highest Dose (TCID50) |
Grade 3/4 toxicities | Efficacy | Viral Detection Serum/CSF/Stool/ Urine/Feces |
Antibody Response |
Reference | Comments |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intra Tumoral | ||||||||||||
| 1 | Solid tumors | 18 | 1 | 10*7 (PFU) | 10*10 (PFU) | None | 1 CR, 1 PR, 8 SD | Serum | Yes | 33 | ||
| 2 | Prostate | 6 | Pilot | 10*7 (PFU) | None | 1 PR, 4 SD | Urine | Yes | 34 | |||
| 3 | Malignant Gliomas | 12 | 1 | 1 × 10*7 | 1 × 10*9 | Transient GGT elevation | 1 SD | Saliva, Feces | Yes | |||
| 6 | Solid tumors | XRT 20–36 Gy | 23 | 1 | 1 × 10*8 | 1 × 10*10 | None | 7 PR, 7 SD | None | Yes | 39 | |
| 7 | Malignant Gliomas | 15 | 1//2 | 1 × 10*8 | 1 × 10*10 | NR | NR | NR | NR | |||
| 8 | Solid tumors | XRT-20 Gy | 16 | 2 | 1 × 10*10 | None | 4 PR, 2 MR, 7 SD | NR | Yes | 40 | ||
| Intravenous | ||||||||||||
| 4 | Solid tumors | 18 | 1 | 1 × 10*8 | 3 × 10*10 | None | 1 PR, 7 SD | Urine, Serum, Saliva, Feces | Yes | 41 | ||
| 5 | Solid tumors | 33 | 1 | 1 × 10*8 | 3 × 10*10 | Flu like syndrome CPK-MB/Trop I elevation Lymphopenia Neutropenia | 3 MR, 7 SD | Urine, Serum, Saliva, Feces | Yes | 44 | ||
| 9 | Solid tumors | Gemcitabine 1000 mg/m2 | 12 | 1 | 1 × 10*9 | 3 × 10*10 | Flu like syndrome Neutropenia AST/ALT/GGT elevation Trop I elevaton/ST changes | 48 | ||||
| 10 | Solid tumors | Docetaxel 75 mg/m2 | 24 | 1 | 1 × 10*9 | 3 × 10*10 | Febrile neutropenia Thrombocytopenia GI symptoms Hypokalemia Hypotension | 4 PR, 3 MR, 7 SD | Urine, Serum, Saliva, Feces | Yes | 54 | |
| NR | NR | |||||||||||
| 11 | Solid tumors | Carboplatin AUC 5 Paclitaxel 175 mg/m2 | 31 | 1//2 | 3 × 10*9 | 3 × 10*10 | Myelosuppression Hypotension | 8 PR, 6 SD | 56 | Efficacy data among 19 patients with Head and Neck Cancer | ||
| 13 | Colorectal Cancer with liver metastases | 10 | 2 | 1 × 10*10 | Yes | 16 | Virus selectively detected in cancerous liver tissue | |||||
| 14 | Sarcomas | 53 | 2 | 3 × 10*10 | Neutropenia Optic neuritis | 19 SD | NR | NR | ||||
| 15 | Head and Neck Cancer | Carboplatin AUC 5 Paclitaxel 175 mg/m2 | 14 | 2 | 3 × 10*10 | Neutropenia Hypokalemia Fatigue Anemia Nausea Hypotension | 4 PR, 2 SD | NR | NR | 57 | ||
| 16 | NSCLC | Carboplatin AUC 6 Paclitaxel 200 mg/m2 | 22 | 2 | 3 × 10*10 | Myelosuppression Hypotension Fatigue GI symptoms | 6 PR, 13 SD | NR | NR | 58 | ||
| 17 | Pancreatic Cancer | Gemcitabine 800 mg/m2 | 18 | 2 | 3 × 10*10 | Neutropenia | 1 unconfirmed PR 7 SD | NR | NR | 52 |
Abbreviations: AUC: area under the concentration time curve; XRT: radiation; PR: partial response; MR: minimal response; SD: stable disease; NR: not reported; NSCLC: non small cell lung cancer; PFU: particle forming units; TCID: tissue culture infective dose