CALGARY, March 28, 2013 /PRNewswire/ – Oncolytics Biotech Inc. (“Oncolytics” or
the “Company”) (TSX:ONC) (NASDAQ:ONCY) today announced that it has met
the primary overall statistical endpoint in 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 in patients with metastatic stage IIIB,
or stage IV, or recurrent SCCLC who are chemotherapy naïve for their
metastatic or recurrent cancer (REO 021).
The study is a two-stage design with a primary overall endpoint of
objective tumor response rate. The Company saw a sufficient number of
responses in the first stage of the study to proceed with enrollment in
the second stage. A total of up to 36 patients were to be studied in
the second stage. The primary endpoint was met if nine or more patients
in both stages combined had a partial response (PR) or better, which
yields a true response rate of 35% or more. This endpoint was met after
21 evaluable patients were treated on study, nine of which exhibited
PRs, while a further nine showed stable disease (SD) and three,
progressive disease (PD), for a response rate of 42.8% and a disease
control rate (complete response (CR) + PR + SD) of 85.7%.
“We are pleased to have met the response rate endpoint, which builds on
the data we announced from the first stage of this study,” said Dr.
Brad Thompson, President and CEO of Oncolytics. “Based on the positive
data seen to date, we intend to conduct further studies in this
The secondary objectives of the trial, for which data has yet to be
released, 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 are alive and
free of disease progression at six months; and to assess the safety and
tolerability of the treatment regimen in the study population.
About SCC 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 (SCC) 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.
Released March 28, 2013