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Oncolytics Biotech Inc. Reports Data from Randomized Phase 2 Study of REOLYSIN in Ovarian Cancer --Intent-to-Treat Analysis Shows Statistically Significant Reduction in Tumour Burden as Measured by CA-125-- CALGARY

Key Takeaway: Oncolytics Biotech Inc. Reports Data from Randomized Phase 2 Study of REOLYSIN in Ovarian Cancer --Intent-to-Treat Analysis Shows Statistically Significant Reduction in Tumour Burden as Measured by CA-125-- CALGARY, March 21, 2016 /CNW/ - Oncolytics Biotech Inc. (TSX: ONC) (

Full Press Release Details

Oncolytics Biotech Inc. Reports Data from Randomized Phase
2 Study of REOLYSIN in Ovarian Cancer
--Intent-to-Treat Analysis Shows Statistically
Significant Reduction in Tumour Burden as Measured by CA-125--
CALGARY, March 21, 2016 /CNW/ - Oncolytics Biotech
Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") today announced an update for a randomized
Phase II clinical trial of its lead product, REOLYSIN , in combination with paclitaxel in patients with ovarian
cancer (GOG-0186H). The study is being sponsored by the US National Cancer Institute ("NCI"). The update includes data
from a Gynecologic Oncology Group (GOG) study summary report, and follows a presentation made by the principal investigator regarding
the study at the Society of Gynecologic Oncology's Annual Meeting on Women's Cancer, which runs from March 19-22 in San Diego,
Response Using CA-125 Measurements by Treatment Among all
CA-125 Response Treatment
Paclitaxel Paclitaxel+REOLYSIN Total
Full Response 1 (1.85%) 5 (9.26%) 6
Partial Response 9 (16.67%) 7 (12.96%) 16
Stable Disease 3 (5.56%) 12 (22.22%) 15
Progressive Disease 0 (0.00%) 2 (3.70%) 2
Indeterminate 16 (29.63%) 13 (24.07%) 29
Not Evaluable 25 (46.30%) 15 (27.78%) 40
Total 54 54 108
Source: GOG Study Summary Report
The Company performed an intent-to-treat analysis of tumour
response, as assessed by CA-125 antigen levels, which showed statistically significantly higher full response rates and stable
disease or better rates in the test arm versus the control arm. The rate of full responses in the test arm was 9.26%, compared
with 1.85% in the control arm (p = 0.0196). The rate of stable disease or better in the test arm was 44.44%, compared with 24.08%
in the control arm (p = 0.0096). The response rates were defined using a modified Rustin's criteria. CA-125 levels are commonly
used in clinical practice to assess response in ovarian cancer patients.
Response rates as measured by RECIST were performed on patients
with measurable disease (n = 68 (of 108)). The proportion responding on the test arm was 17% whereas the proportion responding
on the control arm was 20%.
An analysis of progression free survival ("PFS")
stratified by measurable disease and platinum-free interval (test arm: n = 54, 43 events (progressions), and control arm: n = 54,
48 events) was performed and demonstrated a median PFS of 4.4 months for the test arm, and 4.3 months for the control arm.
An interim analysis of overall survival ("OS") (test
arm: n = 54, 32 events (deaths), and control arm: n = 54, 32 events) was performed and demonstrated a median OS of 12.9 months
for the test arm, and 15.0 months for the control arm. The OS was an interim analysis, as 44 (41%) patients out of a total
of 108 patients were alive at the time of analysis. Given the number of patients still alive on the test and control arms with
current survival less than the median, final median OS results are expected to change.
"This is one of a total of six randomized Phase II studies
with REOLYSIN that were designed and sponsored by third parties. The results from these studies will determine
clinical targets, endpoints, and study designs for follow on and registration studies conducted by Oncolytics. In the case of this
ovarian cancer study, we are pleased that REOLYSIN has demonstrated a statistically significant reduction in tumour
burden in ovarian cancer patients as measured by CA-125 levels," said Dr. Brad Thompson, President and CEO of Oncolytics.
"This adds to our results in other indications that have shown improvement in tumour responses. In order to further our understanding
of how REOLYSIN interacts with the immune system, we hope, in conjunction with the principal investigator, to analyze
the PD-1 and CD8+ T lymphocyte levels of patients on entry and correlate these with overall survival and progression
Study Design Summary
The study (GOG-0186H) is a randomized Phase 2 clinical trial of paclitaxel versus paclitaxel plus REOLYSIN in
patients with persistent or recurrent, ovarian, fallopian tube or primary peritoneal cancer. Patients received paclitaxel on days
1, 8 and 15 of each 28-day treatment cycle, with either REOLYSIN (test arm) or placebo (control arm) administered
on days 1 through 5. One hundred and eight patients were randomized (1:1, 54 patients in the control arm, 54 patients in the test
arm). The NCI study did not stratify on entry according to PD-L1 levels or infiltrating CD8+ T lymphocyte levels,
nor were either of those levels measured post-treatment. However, pre-treatment tumour biopsies were taken from the majority of
patients. The primary objectives are PFS and toxicity. The secondary objectives are median overall OS by treatment group, median
PFS by treatment group, and tumour response as measured by RECIST criteria and CA-125 antigen levels. The study was sponsored by
the US National Cancer Institute and conducted by the former GOG, now incorporated into NRG Oncology.
Analysis of the Relationship between Ovarian Cancer Patients'
Immune Status upon Study Entry and Survival
In order to further understand the effects of a patient's immune status prior to treatment with REOLYSIN on PFS
and OS, the principal investigator and the Company are working to quantify the levels of PD-L1 and CD8+ T lymphocytes
in tumours at the time of enrolment. The Company wishes to conduct this analysis to be able to determine what component of PFS
and OS is attributable to PD-L1 and CD8+ T lymphocyte levels on study entry, and what is attributable to REOLYSIN
The basis for this analysis is Hamanishi et al. (2007) (Programmed
cell death 1 ligand 1 and tumour-infiltrating CD8+ T lymphocytes are prognostic factors of human ovarian cancer. PNAS
104(9):3360-3365), which found that the overall survival rates and progression free survival rates for ovarian cancer patients
with high PD-L1 expression on entry were statistically significantly worse than those of patients with low PD-L1 expression on
entry. They also noted that the overall survival rates and progression free survival rates for ovarian cancer patients with high
intraepithelial CD8+ T lymphocyte counts on entry were statistically significantly better than those of patients with
low CD8+ T lymphocyte counts.
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 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 randomized Phase 2 study in
patients with ovarian cancer, 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
SOURCE Oncolytics Biotech Inc.
For further information: NATIONAL Equicom, Nick Hurst, 800
6th Ave. SW, Suite 1600, Calgary, Alberta T2P 3G3, Tel: 403.218.2835, Fax: 403.218.2830, nhurst@national.ca; NATIONAL Equicom,
Michael Moore, San Diego, CA, Tel: 858.886.7813, mmoore@national.ca; Dian Griesel, Inc., Susan Forman, 335 West 38th Street, 3rd
Floor, New York, NY 10018, Tel: 212.825.3210, Fax: 212.825.3229, sforman@dgicomm.com
CO: Oncolytics Biotech Inc.
CNW 17:00e 21-MAR-16
Last updated: Mar 21, 2016