In the news release, Oncolytics Biotech® Inc. Announces
Completion of Patient Enrollment in U.S. Randomized Phase 2 Ovarian
Cancer Study, issued 03-Sep-2014 by
Oncolytics Biotech Inc. over CNW, we are advised by the company
that at the end of the fourth paragraph, "150 patients" should read
"110 patients". The complete, corrected release follows:
Oncolytics Biotech® Inc. Announces Completion of Patient Enrollment
in U.S. Randomized Phase 2 Ovarian Cancer Study
CALGARY, Sept. 3, 2014 /CNW/ - Oncolytics Biotech
Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced that
patient enrollment has been completed in a randomized Phase 2 study
of paclitaxel plus REOLYSIN® versus paclitaxel alone in
patients with persistent or recurrent ovarian, fallopian tube or
primary peritoneal cancer (GOG186H). The study chair is
David E. Cohn, MD, gynecologic
oncology division director at The Ohio State
University Comprehensive Cancer Center – Arthur G. James
Cancer Hospital and Richard J. Solove Research Institute (OSUCCC –
James). This is a legacy study done by the Gynecologic Oncology
Group, now incorporated into NRG Oncology. The trial is sponsored
by the U.S. National Cancer Institute (NCI) through a Clinical
Trials Agreement between the Cancer Therapy Evaluation Program,
Division of Cancer Treatment and Diagnosis, NCI and Oncolytics.
Oncolytics is providing clinical supplies of REOLYSIN.
"Our randomized clinical program continues to gather momentum as
this is the second randomized study sponsored by the NCI that has
completed enrollment in the last quarter," said Dr. Brad Thompson, President and CEO of Oncolytics.
"Ovarian cancer is often diagnosed at a very late stage, requiring
more aggressive interventions and resulting in relatively low
five-year survival rates."
The current study is a randomized Phase 2 trial of weekly
paclitaxel versus weekly paclitaxel with REOLYSIN in patients with
persistent or recurrent ovarian, fallopian tube or primary
peritoneal cancer. Patients were randomized to receive either
paclitaxel alone or paclitaxel plus REOLYSIN. Patients in both arms
received treatment with paclitaxel, with the second arm also
receiving intravenous REOLYSIN. Patients received standard doses of
paclitaxel on days one, eight, and 15 every 28 days. In the second
arm, patients received, on days one through five of each 28-day
cycle, intravenous REOLYSIN at a dose of 3x1010
TCID50.
The primary objectives of the trial are to estimate the
progression-free survival hazard ratio of the combination of weekly
paclitaxel with REOLYSIN to weekly paclitaxel alone in patients
with persistent or recurrent ovarian, fallopian tube, or primary
peritoneal cancer and to determine the frequency and severity of
adverse events associated with treatment with weekly paclitaxel
alone and weekly paclitaxel with REOLYSIN as assessed by Common
Terminology Criteria for Adverse Events (CTCAE). The secondary
objectives are to estimate the progression-free survival and
overall survival of patients treated with weekly paclitaxel alone
and weekly paclitaxel with REOLYSIN; to estimate (and compare) the
proportion of patients who respond to the regimen on each arm of
the study (according to RECIST 1.1 with measurable patients and by
CA-125 for those patients with detectible disease only); and to
characterize and compare progression-free survival and overall
survival in patients with measurable disease (RECIST 1.1 criteria)
and patients with detectable (nonmeasurable) disease. The study
enrolled approximately 110 patients.
NRG Oncology is responsible for following patients and
collecting and collating all patient data. Once complete, the data
will be analyzed and provided to NCI and Oncolytics.
About Ovarian Cancer
The American Cancer Society
estimates that 21,980 American women will be diagnosed with ovarian
cancer and an estimated 14,270 will die from the disease in 2014.
Ovarian cancer accounts for about 5% of all cancer deaths among
women. The prognosis for patients diagnosed with ovarian cancer at
the localized stage is good with a five-year survival rate of 92%;
however, only about 15% of cases are diagnosed at this stage. The
relative 10-year survival rate for all stages combined is
approximately 35%.
About The OSUCCC – James
The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove Research
Institute strives to create a cancer-free world by integrating
scientific research with excellence in education and
patient-centered care, a strategy that leads to better methods of
prevention, detection and treatment. Ohio
State is one of only 41 National Cancer Institute
(NCI)-designated Comprehensive Cancer Centers and one of only four
centers funded by the NCI to conduct both phase I and phase II
clinical trials. The NCI recently rated Ohio
State's cancer program as "exceptional," the highest rating
given by NCI survey teams. As the cancer program's 228-bed adult
patient-care component, The James is a "Top Hospital" in the nation
as ranked by U.S. News & World Report. In December 2014, Ohio
State will open a new 1.1 million square foot, 21-floor
James Cancer Hospital and Solove Research Institute. The
freestanding hospital will feature the nation's first fully
integrated cancer emergency department and above-ground radiation
therapy center as well as a precision cancer medicine clinic and
distinct subspecialty care floors with integrated translational
research labs.
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 later-stage, randomized human trials in
various indications 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 the U.S. Securities Act of 1933, as amended, and
U.S. Securities Exchange Act of 1934, as amended, and
forward-looking information within the meaning of Canadian
securities laws. Statements, other than statements of historical
facts, included in this press release that address activities,
events or developments that Oncolytics expects or anticipates will
or may occur in the future, including such things as, the Company's
expectations related to the GOG186H randomized Phase 2 study of
REOLYSIN in combination with paclitaxel in patients with
persistent or recurrent ovarian, fallopian tube or primary
peritoneal cancer, the Company's belief as to the potential of
REOLYSIN as a cancer therapeutic, and other such matters are
forward-looking statements and forward-looking information and
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 and forward-looking information.
Such risks and uncertainties include, among others, risks related
to the statistical sufficiency of patient enrollment numbers in
separate patient groups, 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 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 statement and forward-looking
information. Investors are cautioned against placing undue reliance
on forward-looking statements and forward-looking information. The
Company does not undertake to update these forward-looking
statements and forward-looking information, except as required by
applicable laws.
SOURCE Oncolytics Biotech Inc.