CALGARY, Jan. 3 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc.
(“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that it has received a
letter of approval from the U.K. Medicines and Healthcare products Regulatory
Agency (MHRA) for its Clinical Trial Application (CTA) to begin a clinical
trial using intravenous administration of REOLYSIN(R) in combination with
gemcitabine (Gemzar(R)) in patients with advanced cancers including
pancreatic, lung and ovarian. The principal investigators are Dr. Johann de
Bono of The Royal Marsden NHS Foundation Trust and The Institute of Cancer
Research, London and Professor Jeff Evans of the University of Glasgow and the
Beatson Oncology Centre in Glasgow, Scotland. Gemcitabine is used in patients
with lung, pancreatic and ovarian cancers and is also used widely in the
treatment of many other types of cancers.
“The combination of REOLYSIN(R) and gemcitabine was synergistic in
preclinical studies,” said Dr. Brad Thompson, President and CEO of Oncolytics.
“The data gathered in this study is expected to assist the company in further
defining the optimal path to product registration. Drug combination studies
allow us to investigate REOLYSIN(R) with drugs that are part of the current
standard of care.”
Preclinical studies conducted at Cornell University demonstrated that the
combination of gemcitabine and REOLYSIN(R) was synergistic against selected
cancer cell lines. This work was verified by additional studies conducted by
the U.S. National Cancer Institute (NCI).
This trial (REO 009) has two components. The first is an open-label,
dose-escalating, non-randomized study of REOLYSIN(R) given intravenously with
gemcitabine every three weeks. A standard dosage of gemcitabine will be
delivered with escalating dosages of REOLYSIN(R) intravenously. A maximum of
three cohorts will be enrolled in the REOLYSIN(R) dose escalation portion. The
second component of the trial will immediately follow and will include the
enrolment of a further 12 patients at the maximum dosage of REOLYSIN(R) in
combination with a standard dosage of gemcitabine.
Eligible patients include those who have been diagnosed with advanced or
metastatic solid tumours including pancreatic, lung and ovarian cancers that
are refractory (have not responded) to standard therapy or for which no
curative standard therapy exists. The primary objective of the trial is to
determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT),
recommended dose and dosing schedule and safety profile of REOLYSIN(R) when
administered in combination with gemcitabine. Secondary objectives include 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.
In the U.K. and the U.S., approximately 280,000 people are diagnosed with
pancreatic, lung and ovarian cancers every year.
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 and Phase II human trials using
REOLYSIN(R), 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
For more information about Gemzar(R), go to www.gemzar.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. combination REOLYSIN(R)/gemcitabine clinical trial, and the Company’s
belief as to the potential of REOLYSIN(R) 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(R) as a cancer treatment, the tolerability
of REOLYSIN(R) outside a controlled test, the success and timely completion of
clinical studies and trials, the Company’s ability to successfully
commercialize REOLYSIN(R), 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.
SOURCE Oncolytics Biotech Inc.
Released January 3, 2007