CALGARY, May 17, 2017 /PRNewswire/ - Oncolytics
Biotech® Inc. (Oncolytics or the Company) (TSX:ONC)
(OTCQX:ONCYF) today announced the publication of abstracts for an
open-label phase 1b trial in patients with metastatic
adenocarcinoma of the pancreas (MAP) (REO 024) and an open-label,
randomized, phase 2 study in metastatic castration resistant
prostate cancer (mCRPC). Data from the studies will be presented
during the American Society of Clinical Oncology (ASCO) Annual
Meeting, June 2-6, in Chicago, IL.
REO 024, a phase 1b study, was designed to assess the safety
(primary endpoint) and dose-limiting toxicity of
REOLYSIN® in combination with pembrolizumab
(KEYTRUDA®) and chemotherapy in patients with
histologically confirmed MAP who have failed, or did not tolerate,
first-line treatment. The study enrolled 11 patients who were given
REOLYSIN plus pembrolizumab, along with one of gemcitabine,
5-fluouracil or irinotecan. Grade 1 and 2 treatment emergent
adverse events (TEAE) occurred in all patients and Grade 3 and 4
TEAE occurred in eight patients. Three of five efficacy evaluable
patients showed a tumor response (secondary endpoint), with one
having a partial response (six-month duration) and two having
stable disease (lasting 126 and 221 days). Investigators noted that
on-treatment biopsies revealed reovirus infection in cancer cells
and immune infiltrates and concluded that the combination therapy
showed manageable safety profiles and anti-tumour activity in
previously treated MAP patients. The abstract, authored by
Mahalingam et al, "A study of REOLYSIN in combination with
Pembrolizumab and chemotherapy in patients (pts) with relapsed
metastatic adenocarcinoma of the pancreas (MAP)," is now available
on the ASCO annual meeting website.
"We continue to expand our library of clinical data and
establish REOLYSIN as safe in combination with KEYTRUDA, a highly
promising checkpoint inhibitor," said Dr. Andres Gutierrez, CMO of Oncolytics. "This
is a major first step in supporting the adaptive immunity component
of our clinical development plan, and it opens the door for
additional collaborations with other checkpoint inhibitors as we
advance the longer-term, immuno-oncology portion, of the clinical
development plan. We look forward to announcing further
developments for this program later in the year."
The phase 2 study in prostate cancer was an 85-patient trial
designed and executed by the Canadian Cancer Trials Group (CCTG)
(IND 209) to assess the therapeutic combination of
intravenously-administered REOLYSIN given in
combination with docetaxel/prednisone versus docetaxel/prednisone
alone in patients with mCRPC. The study did not meet its primary
endpoint of 12-week lack of progression, which was comparable in
both the test and control arms, or the secondary endpoint of
overall survival. The abstract reports significant differences at
baseline, where more patients had poor prognostic factors for
survival in the test arm versus the control arm. In addition, while
the combination of REOLYSIN and docetaxel was tolerated, dose
reductions were more common on the test arm with only 51 percent of
the patients receiving 90% of the planned dose intensity of
docetaxel, versus 76 percent on the control arm.
"In recent years, we and our collaborators have performed
numerous phase 1b and phase 2 trials to better understand the
anti-tumour mechanisms of REOLYSIN, to identify the best therapies
to pair with REOLYSIN, and to identify the cancer indications for
which REOLYSIN provides clear benefit," said Dr. Matt Coffey, President and CEO of Oncolytics.
"Collectively, these findings reinforce our Clinical Development
Plan. While these results themselves indicate that prostate cancer
is likely not a viable tumor target, they do not impact our focus
on the advancement of REOLYSIN into a phase 3 registration study in
patients with metastatic breast cancer. We thank the investigators,
staff and patients that participated in these trials that delivered
very important data to guide the late stage development of REOLYSIN
toward patient populations that can most benefit from its
immune-oncology effects."
The abstract, authored by Eigl et al, "A randomized phase
II study of pelareorep (REO) plus docetaxel vs. docetaxel alone in
patients with metastatic castration resistant prostate cancer
(mCRPC): Canadian Cancer Trials Group study IND 209," is now
available on the ASCO annual meeting website.
About Oncolytics Biotech Inc.
Oncolytics is a
biotechnology company developing REOLYSIN, an immuno-oncology
viral-agent, as a potential treatment for a variety of tumor types.
The compound induces selective tumor lysis and promotes an inflamed
tumor phenotype through innate and adaptive immune responses to
treat a variety of cancers. Oncolytics' clinical development
program emphasizes three pillars: chemotherapy combinations to
trigger selective tumor lysis; immuno-therapy combinations to
produce adaptive immune responses; and immune modulator (IMiD)
combinations to facilitate innate immune responses.
Oncolytics is currently planning its first registration study in
breast cancer, as well as studies in combination with checkpoint
inhibitors and IMID/targeted therapies in solid and hematological
malignancies. 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 Phase 2 clinical trial in
prostate cancer and the Phase 1b
trial in pancreatic cancers, future trials in these indications,
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.