Full Press Release Details
Oncolytics Biotech Inc. Announces Positive Results
U.K. Phase II REOLYSIN and Radiation Combination Clinical
CALGARY, AB, --- April 7, 2009 - Oncolytics Biotech Inc.
("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced positive results in
its U.K. Phase II clinical trial to evaluate the objective tumour response
rate of REOLYSIN in combination with low-dose radiation in patients with
of 16 heavily pretreated patients with advanced cancer (melanoma (5), colorectal
(4), gastric (1), pancreas (1), ovarian (1), lung (1), cholangiocarcinoma (1)
sinus (1), and thyroid (1)) were enrolled in the trial. Most patients
had received prior chemotherapy (13 patients) or radiation (5 patients). Of 14
patients evaluable for response, 13 patients had stable disease (SD) or better
in the treated target lesions. Of these, partial responses (PR) were
observed in four patients (lung, melanoma (2) and gastric) and minor responses
were observed in two patients (thyroid, ovarian), for a total disease control
rate (stable disease + partial response + complete response) of 93% in the
treated lesions. The combination was well tolerated, with only mild
(Grade 1 or 2) toxicities noted.
a very high disease control rate in patients who have undergone prior
therapies," said Dr. Brad Thompson, President and CEO of Oncolytics. "This
combination resulted in marked responses or stabilization in the treated target
lesions for most of the patients. These results are expected to allow us to
pursue REOLYSIN in combination with radical radiotherapy in future clinical
(REO 008) was an open-label, single-arm, multi-centre Phase II study of REOLYSIN
delivered via intratumoural injection to patients during treatment with low-dose
fractionated radiotherapy. 20 Gy of radiation was given in five
consecutive daily 4 Gy fractions combined with two intratumoural injections of
REOLYSIN (1x10(10) TCID(50)) on days two and four. The primary endpoint was
objective tumour response rate in treated lesions. Secondary endpoints were to
evaluate viral replication, immune response, and safety. Eligible patients
included those diagnosed with advanced or metastatic cancers that are refractory
(have not responded) to standard therapy or for which no curative standard
therapy exists. The Phase II trial followed a successful Phase Ia/Ib
combination REOLYSIN/radiation trial in which local and systemic responses were
Principal Investigator for the trial is Dr. Kevin Harrington of the Targeted
Therapy Laboratory, Cancer Research UK Centre for Cell and Molecular Biology at
The Institute of Cancer Research and Honorary Consultant in Clinical Oncology at
The Royal Marsden NHS Foundation Trust.
Oncolytics Biotech Inc.
is a Calgary-based biotechnology company focused on the development of oncolytic
viruses as potential cancer therapeutics. Oncolytics' clinical
program includes a variety of Phase I/II and Phase II human trials
using REOLYSIN, its proprietary formulation of the human reovirus, alone and in
combination with radiation or chemotherapy. For further information
about Oncolytics, please visit www.oncolyticsbiotech.com
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 U.K. Phase II
combination REOLYSIN/radiation clinical trial, 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 law.
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