Date: 2015-08-30
Type of information: Completion of patient enrollment
phase: 2
Announcement: completion of patient enrollment
Company: Oncolytics Biotech (Canada) NCIC Clinical Trials Group (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: previously treated advanced or metastatic non-small cell lung cancer
Therapeutic area: Cancer - Oncology
Country: Canada
Trial details:
Latest
news: * On August 26, 2015, Oncolytics Biotech announced that enrollment has been completed in a randomized Phase II study of Reolysin® in patients with previously treated advanced or metastatic non-small cell lung cancer (IND 211). The trial is being sponsored and conducted by the NCIC Clinical Trials Group (NCIC CTG) at Queen's University in Kingston, Ontario. The study is an open-label, randomized, non-blinded, Phase II clinical study of Reolysin® as a treatment for advanced or metastatic non-small cell lung cancer patients who have received previous chemotherapy. A total of 166 patients were enrolled. Patients with squamous cell histology were randomized to receive either REOLYSIN® given in combination with docetaxel (test arm) or docetaxel alone (control arm), while patients with non-squamous cell histology were randomized to receive either Reolysin® given in combination with pemetrexed (test arm) or pemetrexed alone (control arm). The primary objective of the trial is to evaluate the effect of Reolysin® in combination with standard salvage chemotherapy on the progression free survival of patients with advanced or metastatic non-small cell lung cancer. The secondary objectives are to determine the tolerability and toxicity of the therapeutic combination; to investigate additional potential measures of efficacy, including progression rates at three months, objective response rate and overall survival; and to explore potential molecular factors predictive of response. Although accrual is complete, patient follow-up will continue until planned analyses have been conducted.
