CALGARY, Nov. 29 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc. (“Oncolytics”)
(TSX:ONC, NASDAQ:ONCY) announced today that a paper entitled “REO-10: A
Phase I Study of Intravenous Reovirus and Docetaxel in Patients with
Advanced Cancer,” was recently published by Comins et al in the journal Clinical Cancer Research (Clin Cancer Res
16(22):5564-5572).
The paper reports final results from a combination REOLYSIN and
docetaxel trial, (REO 010) designed to evaluate the anti-tumour effects
of systemic administration of REOLYSIN in combination with docetaxel
(Taxotere®) in patients with advanced cancers. Patients received docetaxel on day
one (75mg/m2) and escalating doses of reovirus up to 3 x 1010 TCID50 on days one through five, every three weeks. The principal investigator
was Professor Hardev Pandha of the Royal Surrey County Hospital, U.K.
Twenty-five patients were enrolled, with 24 being exposed to treatment
and 23 completing at least one cycle of therapy. Sixteen patients were
suitable for response assessment. The combination was deemed to be safe
and well tolerated and a maximum tolerated dose was not reached.
Antitumour activity was seen with one complete response (in the liver
of a breast cancer patient with no evidence of disease recurrence at
the end of the study, following eight cycles of treatment) and three
partial responses. A disease control rate (combined complete response,
partial response and stable disease) of 88% was observed. The authors
concluded that the combination of reovirus and docetaxel is safe, with
evidence of objective disease response, and warrants further evaluation
in a Phase II study at a recommended schedule of docetaxel (75mg/m2, three times weekly) and reovirus (3 x 1010 TCID50, days one to five, every three weeks).
Eligible patients included those who had been diagnosed with advanced or
metastatic solid tumours including bladder, lung, prostate or upper
gastro-intestinal cancers that were refractory (had not responded) to
standard therapy or for which no curative standard therapy existed. The
primary objective of the trial was to determine the MTD, Dose-Limiting
Toxicity, recommended dose and dosing schedule and safety profile of
REOLYSIN when administered in combination with docetaxel. Secondary
objectives included the evaluation of immune response to the drug
combination, the body’s response to the drug combination compared to
chemotherapy alone and any evidence of anti-tumour activity.
“These findings demonstrate a clear benefit for patients, even at lower
doses, and provide us with additional patient data on another
REOLYSIN/chemotherapy combination that we may elect to advance into
later stage testing in the future,” said Dr. Brad Thompson, President
and CEO of Oncolytics.
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 implication of the
materials presented in “Clinical Cancer Research” with respect to
REOLYSIN, 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
laws.
SOURCE Oncolytics Biotech Inc.
Released November 29, 2010