Oncolytics Biotech® Inc. Meets Primary Overall Statistical Endpoint in U.S.
Phase 2 Study of REOLYSIN® in Squamous Cell Lung Cancer
CALGARY, March 28, 2013
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
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 indication."
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 Societyestimates 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 inthe United Statesin 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 towww.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:
This press release contains forward-looking statements, within the meaning of
Section27A 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.
The Equicom Group
300 5^th Ave. SW, 10^th Floor
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396 West Broadway, 2^nd Floor
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