Date: 2015-02-18
Type of information: Completion of patient enrollment
phase: 2
Announcement: completion of patient enrollment
Company: Oncolytics Biotech (Canada)
Product: Reolysin® (pelareorep - human reovirus type 3 Dearing strain)
Action
mechanism: oncolytic virus. Reolysin® is a proprietary variant of the respiratory enteric orphan virus (reovirus). The reovirus is non-pathogenic. The reovirus is able to infect and selectively destroy cancer cells. When a normal cell is infected with the reovirus, an antiviral response is activated, which prevents the virus from replicating within the cell. However, inside a cancer cell with one or more mutations on a growth pathway called the Ras pathway, there is an aberrant antiviral response that is unable to prevent the virus from replicating. This abnormality allows the reovirus to multiply to an extent that is fatal to the cancer cell.
In clinical trials, Reolysin® has been shown to be well-tolerated, with patients exhibiting only mild, flu-like symptoms. It has been used alone and in combination with chemotherapy and radiotherapy for various cancers, including head and neck cancers in an ongoing Phase III clinical trial. Oncolytics has supported two sponsored clinical studies assessing Reolysin® in the treatment of ovarian cancer. The first was a Phase 1/2 clinical trial (OSU-07022) for patients with metastatic ovarian, peritoneal and fallopian tube cancers using concurrent intravenous and intraperitoneal administration of Reolysin® that provided evidence of viral targeting and replication in peritoneal and ovarian cancer cells. The second is an ongoing randomized Phase II trial (GOG186H) of weekly paclitaxel versus weekly paclitaxel with Reolysin® in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer. The second trial completed enrollment in September 2014.
Disease: advanced or metastatic colorectal cancer
Therapeutic area: Cancer - Oncology
Country: Canada
Trial
details: The purpose of this study is to find out if giving reolysin in combination with FOLFOX6/ bevacizumab can offer better results than standard therapy with FOLFOX6/ bevacizumab. (NCT01622543)
Latest
news: * On February 18, 2015, Oncolytics Biotech® announced that enrollment has been completed in a randomized Phase II study of Reolysin® in patients with advanced or metastatic colorectal cancer (IND 210). The trial is being sponsored and conducted by the NCIC Clinical Trials Group (NCIC CTG) at Queen's University in Kingston, Ontario. This study is an open-label, randomized, non-blinded, phase II clinical study of Reolysin® as first-line palliative treatment for patients with advanced or metastatic colorectal cancer. A total of 103 patients were enrolled after completion of a six-patient safety run in. Patients were randomized to receive either FOLFOX-6 and bevacizumab alone (control arm) or FOLFOX-6 and bevacizumab plus Reolysin® (test arm). Patients in both arms received standard doses of FOLFOX-6 and bevacizumab on a bi-weekly basis. Patients in the test arm also received intravenous Reolysin® at a dose of 3x1010TCID50 on days one through five of the first, second, fourth, sixth and eighth 14-day cycles, and alternate cycles thereafter. The primary objective of the trial is to evaluate the effect of Reolysin® in combination with standard FOLFOX-6 and bevacizumab therapy on the progression-free survival of patients with advanced or metastatic colorectal cancer. The secondary objectives are to determine the tolerability and toxicity of the therapeutic combination; to investigate additional potential measures of efficacy, including change in CEA levels, objective response rate and overall survival; to explore potential molecular factors predictive of response, including KRAS status, by assessment of archival tumour tissue; and to assess quality of life, as measured by the EORTC QLQC30. Although accrual is complete, follow up of patients until disease progression continues.
