Oncolytics Biotech Inc. (ONC.TO)'s REOLYSIN® Shrinks Tumors in 92 Percent of Patients in Phase 2 Trial; Stock Rockets +12.83% at Market Close (September 9, 2013)
9/9/2013 6:55:51 AM
Oncolytics Biotech® Inc. Announces Positive Final Tumour Response Data for U.S. Phase 2 Study of REOLYSIN® in Squamous Cell Lung Cancer
CALGARY, Sept. 9, 2013 /PRNewswire/ - Oncolytics Biotech Inc. ("Oncolytics")
(TSX:ONC) (NASDAQ:ONCY) today announced final tumour response data from
its U.S. Phase 2 single arm clinical trial in patients with squamous
cell carcinoma of the lung (SCCLC) using intravenous administration of
REOLYSIN in combination with carboplatin and paclitaxel (REO 021).
The analysis examined percent best overall tumour responses between
pre-treatment and up to six treatment cycles. Of 25 evaluable patients
who had more than one cycle of therapy, 23 (92%) exhibited overall
tumour shrinkage (mean shrinkage was 32.7%). Of the 25 evaluable
patients, 10 (40%) had partial responses (PRs), while a further 13
(52%) showed stable disease (SD) and two (8%), had progressive disease
(PD), for a disease control rate (complete response (CR) + PR + SD) of
92%. A waterfall graph showing individual patient data will be
available on the Company's website at http://www.oncolyticsbiotech.com/presentations.
"We are thrilled to have demonstrated 92% overall tumour shrinkage in
this group of patients," said Dr. Brad Thompson, President and CEO of
Oncolytics. "Squamous cell carcinoma of the lung is notoriously
difficult to treat, and these results support further investigation of
REOLYSIN in randomized clinical trials for this indication."
The study enrolled patients with metastatic stage IIIB or stage IV, or
recurrent, squamous cell carcinoma of the lung, who were
chemotherapy-naïve for their metastatic or recurrent cancer. The
primary objective of the trial is to evaluate the patients' tumour
response. The secondary objectives are to assess progression-free
survival and overall survival for the treatment regimen in the study
population; to determine the proportion of patients receiving the above
treatment who were alive and free of disease progression at six months;
and to assess the safety and tolerability of the treatment regimen in
the study population. Final progression-free survival and safety data
for the study will be reported later in 2013.
About Lung Cancer
The American Cancer Society estimates that in 2013, approximately
228,190 new cases of lung cancer will be diagnosed. Between 85% and 90%
of all lung cancers are classified as non-small cell lung cancer
(NSCLC); squamous cell carcinomas account for 25-30% of all lung
cancers. Lung cancer is by far the leading cause of cancer death among
both men and women. There will be an estimated 159,480 deaths from lung
cancer in the United States in 2013, accounting for around 27% of all
cancer deaths. Lung cancer is the leading cause of cancer death, with
more people dying each year of lung cancer than from colon, breast, and
prostate cancers combined. For more information about SCC lung cancer,
please go to www.cancer.org.
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 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements, including the Company's expectations
related to the U.S. Phase II squamous cell carcinoma lung cancer trial,
future trials in this indication, 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, development and manufacturing of pharmaceuticals, changes in
technology, general changes to the economic environment 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
should consider statements that include the words "believes",
"expects", "anticipates", "intends", "estimates", "plans", "projects",
"should", or other expressions that are predictions of or indicate
future events or trends, to be uncertain and forward-looking. 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.
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