CALGARY, April 7 /CNW/ - 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(R) in
combination with low-dose radiation in patients with advanced cancers.
A total 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.
"This is 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
The trial (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 noted.
The 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.
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 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.
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 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.
For further information:
For further information: Oncolytics Biotech Inc.: Cathy Ward, 210, 1167
Kensington Cr NW, Calgary, Alberta, T2N 1X7, Tel: (403) 670-7377, Fax: (403)
283-0858, firstname.lastname@example.org; The Equicom Group: Nick Hurst, 325-300 5th
Ave. SW, Calgary, AB, T2P 3C4, Tel: (403) 538-4845, Fax: (403) 266-2453,
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