CALGARY, June 29, 2016 /PRNewswire/ - Oncolytics Biotech
Inc. ("Oncolytics" or the "Company") (TSX: ONC)
(OTCQX: ONCYF) (FRA: ONY) today announced that, following
submission to the U.S. Food and Drug Administration ("FDA")
for review, the Investigational New Drug Application containing the
protocol titled "Phase 2 study of REOLYSIN®
(pelareorep) in combination with FOLFOX6, bevacizumab and
pembrolizumab in female patients with KRAS-mutant colorectal cancer
metastatic to the liver" is now active.
"This study is intended to confirm the
encouraging objective overall and liver metastases response rates
in female patients that we saw in a sponsored randomized Phase II
study conducted in Canada," said
Dr. Brad Thompson, President and CEO
of Oncolytics. "We are adding a checkpoint inhibitor to the
treatment regimen based on our evolving understanding of how
REOLYSIN® upregulates immune responses and how the
combination may make cancer cells more susceptible to attack by the
immune system."
This is a multicenter, single arm safety and
efficacy study of REOLYSIN® in combination with
chemotherapy (FOLFOX6), bevacizumab (Avastin®) and
pembrolizumab (KEYTRUDA®) in female patients with
KRAS-mutant metastatic colorectal cancer (CRC) in the liver. The
primary objective is to evaluate the overall response rate (ORR)
according to Immune-related Response Evaluation Criteria in Solid
Tumors ("irRECIST"). Secondary objectives include evaluating
disease response in liver metastases and overall survival. The
Company also intends to examine the effect of study treatment on
immune-related cells and biomarkers associated with immune
response; and genetic biomarkers associated with positive response
to study treatment. Study enrollment will be approximately 30
patients.
Oncolytics recently announced data from a
sponsored Phase 2 study of REOLYSIN®, in combination
with FOLFOX6 and bevacizumab in patients with advanced or
metastatic CRC (IND 210). In that study, the overall test arm had
an objective response rate of 52.9% (n=51) versus 34.6% (n=52) in
the control arm (p=0.06). The Company conducted a pre-planned
analysis of patient responses by gender, as specified in the study
protocol. The female patients in the test arm had an objective
response rate of 63.2% (n=19) versus 23.8% (n=21) in the control
arm (p=0.0054), and in the test arm had a median overall survival
of 19.3 months (n=19) versus 14.5 months (n=21) in the control arm.
The overall survival was an interim analysis, as 62 of 103 patients
overall were alive at the time of data cut off. The male patients
in the test arm had an objective response rate of 46.9% (n=32)
versus 41.9% (n=31) in the control arm (p=0.6747). For patients
(both male and female) who had metastases to the liver, those
treated with REOLYSIN® had objective tumour response
rates of 55% (n=40), versus 28.6% (n=42) for those who did not
receive REOLYSIN® (p=0.0077).
About Colorectal Cancer
The American Cancer Society estimates that 134,490 Americans
(63,670 women) will be diagnosed with colorectal cancer and an
estimated 49,190 Americans (23,170 women) will die from the disease
in 2016. The five- and ten-year survival rates are 65% and 58%,
respectively, however five-year survival drops to 13% in cases
where the cancer spreads to other parts of the body, away from the
primary tumour.
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 phase 2 study in female patients with
colorectal cancer metastatic to the liver, 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 statements 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.