Oncolytics Biotech(R) Inc. Announces Positive Data from Translational Clinical Trial Investigating REOLYSIN(R) in Patients with Metastatic Colorectal Cancer
CALGARY, April 20 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc. (“Oncolytics”) (TSX:
ONC) (NASDAQ: ONCY) today announced interim data from a U.K.
translational clinical trial (REO 013) investigating intravenous
administration of REOLYSIN in patients with metastatic colorectal
cancer prior to surgical resection of liver metastases. The principal
investigator of the study was Professor Alan Melcher of Leeds Institute
of Molecular Medicine, University of Leeds, UK.
The trial was an open-label, non-randomized, single centre study of
REOLYSIN given intravenously to patients for five consecutive days in
advance of their scheduled operations to remove colorectal cancer
deposits metastatic to the liver. Patients were treated with
intravenous REOLYSIN at 1×10(10) TCID(50), one to three weeks prior to planned surgery. After surgery, the tumour
and surrounding liver tissue were assessed for viral status and
On initial histological analysis of the 10 treated patients to date,
there was evidence of selective delivery of virus to tumour versus
normal liver and viral replication in the majority (seven) of patients.
In two patients, only necrotic tumour was found; in one of these cases
virus was detected in immune cells in the tumour. In six of 10 patients
there was no evidence of virus in the normal liver surrounding the
tumour, with virus found only rarely in liver cells in the other four
patients. Final and complete results from the study are expected to be
presented in 2011.
“These data suggest reovirus can be intravenously administered as a
monotherapy and successfully delivered specifically and selectively to
colorectal liver metastases without affecting surrounding normal liver
tissue,” said Dr. Brad Thompson, President and CEO of Oncolytics.
“Based on these results, we are now planning a further translational
study co-administering reovirus with FOLFIRI (Folinic Acid (leucovorin)
+ Fluorouracil (5-FU) + Irinotecan), which would further build our
knowledge of how to maximize the efficacy of this novel therapy in
cancer patients. This study would be complementary to our ongoing
Phase I study of REOLYSIN in combination with FOLFIRI in patients with
oxaliplatin refractory/intolerant Kras mutant colorectal cancer.”
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the
development of oncolytic viruses as potential cancer therapeutics.
Oncolytics’ clinical program includes a variety of human trials
including a Phase III trial in head and neck cancers using REOLYSIN,
its proprietary formulation of the human reovirus. For further
information about Oncolytics, please visit: www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the
meaning of Section 21E of the Securities Exchange Act of 1934, as
amended. Forward-looking statements, including the Company’s
expectations related to the results reported from the U.K.
translational study for patients with metastatic colorectal cancer with
liver metastases, and the Company’s belief as to the potential of
REOLYSIN as a cancer therapeutic, involve known and unknown risks and
uncertainties, which could cause the Company’s actual results to differ
materially from those in the forward-looking statements. Such risks and
uncertainties include, among others, the availability of funds and
resources to pursue research and development projects, the efficacy of
REOLYSIN as a cancer treatment, the tolerability of REOLYSIN outside a
controlled test, the success and timely completion of clinical studies
and trials, the Company’s ability to successfully commercialize
REOLYSIN, uncertainties related to the research and development of
pharmaceuticals and uncertainties related to the regulatory process.
Investors should consult the Company’s quarterly and annual filings
with the Canadian and U.S. securities commissions for additional
information on risks and uncertainties relating to the forward-looking
statements. Investors are cautioned against placing undue reliance on
forward-looking statements. The Company does not undertake to update
these forward-looking statements, except as required by applicable
SOURCE Oncolytics Biotech Inc.