Intravenous Administration of REOLYSIN® in Combination with FOLFIRI for Patients with Colorectal Cancer
In May 2010, following submission to the US Food and Drug Administration (FDA) for review, Oncolytics announced that it was initiating a US Phase I study of REOLYSIN® in combination with FOLFIRI (Folinic Acid (leucovorin) + Fluorouracil (5-FU) + Irinotecan) in patients with oxaliplatin refractory/intolerant Kras mutant colorectal cancer (REO 022). The principal investigator is Dr. Sanjay Goel of the Montefiore Medical Center at the Albert Einstein College of Medicine in New York.
The trial is a Phase I dose escalation study with three dose levels and cohorts of three to six patients to determine a maximum tolerated dose and dose-limiting toxicities with the combination of REOLYSIN® and FOLFIRI. FOLFIRI will be administered on the first day of a two week (fourteen day) cycle, while REOLYSIN® will be administered on days one through five of a four week (twenty-eight day) cycle.
Eligible patients include those with histologically confirmed cancer of the colon or rectum with Kras mutation and measurable disease. They must have progressed on or within one hundred and ninety days after last dose of oxaliplatin regimen as front-line therapy in the metastatic setting or be intolerant to oxaliplatin.
The rationale for conducting the study is based on signals of efficacy seen in a range of preclinical and clinical work with REOLYSIN®. This includes a National Cancer Institute screen of seven colorectal cancer cell lines (four with ras mutations), all of which were susceptible to REOLYSIN®, preclinical research into the efficacy of REOLYSIN® in combination with various chemotherapeutic agents in colorectal cancer cell lines, observation of CEA responses and stable disease in colorectal patients in a Phase I study of REOLYSIN® as a monotherapy, and evidence of viral replication of reovirus in liver metastases in patients with metastatic colorectal cancer in a translational study with REOLYSIN® as a monotherapy that is currently ongoing.
- January 28, 2013: Oncolytics Biotech® Inc. Announces Positive REOLYSIN® Clinical Trial Data Presented at ASCO Gasterointestinal Cancers Symposium (Press Release)
- August 16, 2012: Oncolytics Biotech® Inc. Completes Patient Enrollment in U.S. Phase I Clinical Trial Investigating REOLYSIN® in Combination with FOLFIRI in Patients with Colorectal Cancer (Press Release)