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FOR IMMEDIATE RELEASE
Oncolytics Biotech ® Inc. Announces Phase I Colorectal Cancer Study
CALGARY, AB, --- May 19, 2010 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY)
announced today that following submission to the U.S. Food and Drug Administration (FDA) for review, the
Company is initiating a U.S. 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.
“We made the decision to conduct a trial in this indication following observed activity in colorectal cancers with
REOLYSIN in both the clinical and preclinical settings,” said Dr. Brad Thompson, President and CEO of
Oncolytics. “Up to 45% of second line colorectal cancer patients have Kras mutations. This makes this an
attractive target for REOLYSIN which appears to be active in tumors with this mutation.”
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 (14 day) cycle, while REOLYSIN will be
administered on days one through five of a four week (28 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 190 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 Institu