CALGARY, Sept. 28 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc.
(“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) today announced that an oral
presentation covering interim results from a U.K. Phase Ia/Ib combination
REOLYSIN(R) and radiation clinical trial for patients with advanced or
metastatic cancers is scheduled to be presented at the National Cancer
Research Institute (NCRI) conference on October 2, 2007 in Birmingham, U.K.
The presentation, entitled “Biological Approaches to Radiosensitisation:
Viruses, Gene Therapy and Novel Radiosensitisers” will be presented by Dr.
Kevin Harrington of The Institute of Cancer Research, London and one of the
principal investigators for the trial. The conference runs from September 30
through October 3, 2007 in Birmingham, U.K.
“We are very pleased with the results of this trial to date,” said Dr.
Brad Thompson, President and CEO of Oncolytics. “We continue to evaluate the
data and look forward to announcing final results.”
To date, 22 patients have been treated with 15 having completed the study.
Five patients withdrew from the study, and two patients are still on study.
A total of 11 patients in the Ia portion of the trial received two
intratumoural treatments of REOLYSIN(R) at dosages of 1×10(8), 1×10(9), or
1×10(10) TCID(50) with a constant localized radiation dose of 20 Gy given in
five fractions. Of these 11 patients, three patients (oesophageal, squamous
skin carcinoma and squamous cell scalp) experienced significant partial
responses.
One month following treatment, the oesophageal patient experienced a 28.5%
reduction in the target tumour, with stable disease noted in four, non-treated
tumours. At two and three months, the target tumour had shrunk 64%, with
stable disease continuing in the four non-treated tumours, including a 15%
volume reduction in non-treated mediastinal disease that was maintained for
more than six months. The squamous skin cancer patient experienced a 50%
reduction in the target tumour, as well as stable disease in two, non-treated
tumours at one, two and three months post treatment. The squamous cell scalp
patient experienced stable disease in the target tumour for two months which
then became a partial response at three months. This patient also experienced
stable disease in one non-treated tumour measured at three months
post-treatment.
Patients in the Ib portion received either two, four or six intratumoural
doses of REOLYSIN(R) at 1×10(10) TCID(50) with a constant localized radiation
dose of 36 Gy given in 12 fractions. Of the six patients who have completed
the study to date, three patients (colorectal, melanoma and lung cancer)
experienced tumour regression in the target tumour, as well as stable disease
in non-treated tumours.
The colorectal patient experienced a partial response with a more than 50%
regression in the target tumour as well as stable disease in four, non-treated
tumours measured at one month following treatment. A melanoma patient
experienced minor regression in the target tumour as well as stable disease in
two, non-treated tumours at one and two months following treatment. A lung
cancer patient experienced minor regression in the target tumour, as well as
stable disease in three, non-treated tumours at two months following
treatment.
The treatment has been well tolerated, with mostly Grade 1 or 2 toxicities
noted including fatigue, lymphopenia, fever, and neutropenia. Grade 3
toxicities including cellulitis, dysphasia and diarrhoea were related to
disease progression and not to the combination treatment. Viral replication
was unaffected by cellular irradiation.
The primary objective of the Phase Ia/Ib trial is to determine the maximum
tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of
REOLYSIN(R) when administered intratumourally to patients receiving radiation
treatment. A secondary objective is to examine any evidence of anti-tumour
activity. Eligible patients include those who have been diagnosed with
advanced or metastatic solid tumours that are refractory (have not responded)
to standard therapy or for which no curative standard therapy exists.
The principal investigators for the trial are Dr. Kevin Harrington of the
Targeted Therapy Laboratory, The Institute of Cancer Research, Cancer Research
UK Centre for Cell and Molecular Biology and Honorary Consultant in Clinical
Oncology at The Royal Marsden NHS Foundation Trust, London, UK, and Dr. Alan
Melcher of the Cancer Research U.K. Clinical Centre at St. James’s University
Hospital in Leeds. The trial is enrolling patients at the Royal Marsden and
St. James’s Hospitals in the U.K.
Further results of the combination REOLYSIN(R) and radiation trial are
scheduled to be presented at the AACR-NCI-EORTC International Conference on
Molecular Targets and Cancer Therapeutics in San Francisco October 22-26,
2007.
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
About The Institute of Cancer Research
The Institute of Cancer Research is Europe’s leading cancer research
centre with expert scientists working on cutting edge research. It was founded
in 1909 to carry out research into the causes of cancer and to develop new
strategies for its prevention, diagnosis, treatment and care. Website at:
www.icr.ac.uk
The Institute works in a unique partnership with The Royal Marsden NHS
Foundation Trust, forming the largest comprehensive cancer centre in Europe.
This relationship enables close daily contact between research scientists and
those on the frontline in the fight against cancer – the clinicians, the
carers and most importantly, the patients.
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 Phase Ia/Ib U.K. combination REOLYSIN(R) and radiation 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
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 September 28, 2007