CALGARY, Dec. 1 /PRNewswire/ – Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC,
NASDAQ:ONCY) announced today the start of enrollment in a randomized
Phase II ovarian cancer study. The Gynecologic Oncology Group (GOG) is
conducting the randomized Phase II trial of weekly paclitaxel versus
weekly paclitaxel with REOLYSIN® in patients with persistent or recurrent ovarian, fallopian tube or
primary peritoneal cancer (GOG186H). The study is being sponsored by
the Cancer Therapy Evaluation Program, Division of Cancer Treatment and
Diagnosis, U.S. National Cancer Institute (NCI), which is part of the
National Institutes of Health, under its Clinical Trials Agreement with
Oncolytics. Oncolytics will provide clinical supplies of REOLYSIN for
this study. The Study Chair is Dr. David E. Cohn of The Ohio State
University Comprehensive Cancer Center – Arthur G. James Cancer
Hospital and Richard J. Solove Research Institute.
“Treating recurrent ovarian cancer is challenging since the response
rates to many chemotherapy regimens is relatively poor,” said Dr. David
E. Cohn. “Novel and targeted approaches to treating this disease hold
promise in improving the outcome for women with recurrent ovarian
cancer, while potentially limiting the side effects associated with
The study is a randomized Phase II trial of weekly paclitaxel versus
weekly paclitaxel with REOLYSIN in patients with persistent or
recurrent ovarian, fallopian tube or primary peritoneal cancer.
Patients will be randomized to receive either paclitaxel alone or
paclitaxel plus REOLYSIN. Patients in both arms will receive treatment
with paclitaxel, with the second arm also receiving intravenous
REOLYSIN. Patients will receive standard doses of paclitaxel on days
one, eight, and 15 every 28 days. In the second arm, patients will also
receive, on days one through five of each 28-day cycle, intravenous
REOLYSIN at a dose of 3×1010 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 is expected to
enroll up to 150 patients.
Information on the study will be available at www.clinicaltrials.gov.
About Ovarian Cancer
The American Cancer Society estimates that 21,880 American women will be
diagnosed with ovarian cancer and an estimated 13,850 will die from the
disease in 2010. Ovarian cancer accounts for about 3% of all cancers
among women and ranks second among gynecologic cancers. The prognosis
for patients diagnosed with ovarian cancer at the localized stage is
good with a five-year survival rate of 94%; however, less than 15% of
cases are diagnosed at this stage. The relative 10-year survival rate
for all stages combined is approximately 38%.
About the Gynecologic Oncology Group
The Gynecologic Oncology Group (GOG) is a non-profit (national)
organization with the purpose of promoting excellence in the quality
and integrity of clinical and basic scientific research in the field of
gynecologic malignancies. The Group (gynecologic oncologists, medical
oncologists, pathologists, radiation oncologists, nurses,
statisticians, basic scientists, quality of life experts, data managers
and administrative personnel) is committed to maintaining the highest
standards in clinical trials development, execution, analysis and
distribution of results. The GOG is one of the National Cancer
Institute’s (NCI) funded cooperative cancer research groups. GOG is the
only group which focuses its research on women with pelvic
malignancies, such as cancer of the ovary, uterus, and cervix.
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 21E of the Securities Exchange Act of 1934, as
amended. Forward-looking statements, including the Company’s
expectations related to the Phase 2 randomized ovarian, fallopian tube or primary peritoneal cancer trial sponsored by the NCI,
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 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, except as required by applicable
SOURCE Oncolytics Biotech Inc.
Released December 1, 2010