Full Press Release Details
Oncolytics Biotech Inc. Collaborators Present Final Data from REO 017
Clinical Study in Pancreatic Cancer
--Report More Than Doubling in One-Year Survival and
Nearly Five-Fold Increase in Two-Year Survival as Compared to Historical Controls--
CALGARY, July 6, 2015 /CNW/ - Oncolytics Biotech
Inc. ("Oncolytics") (TSX:ONC) (NASDAQ:ONCY) today announced that Dr. Devalingam Mahalingam of the Cancer Therapy and
Research Centre, University of Texas Health Science Centre San Antonio, made a poster presentation at the ESMO World Congress on
Gastrointestinal Cancer. The poster, titled "Oncolytic Virus Therapy in Pancreatic Cancer: Clinical Efficacy and Pharmacodynamic
Analysis of REOLYSIN in Combination with Gemcitabine in Patients with Advanced Pancreatic Adenocarcinoma,"
covers final results from the Company's REO 017 Phase 2 study.
"These data suggest that this drug combination can increase median
overall survival, as well as generate an approximate two-fold increase in one-year survival rates, and a five-fold increase in
two-year survival rates when compared to gemcitabine therapy alone as seen in historical data," said Dr. Matt Coffey, COO
of Oncolytics. "The observation of clear overall survival (OS) benefit combined with apparent limited impact on progression
free survival (PFS) is increasingly becoming characteristic of immune-based therapeutic treatments. We are incorporating this finding
into both our new and existing studies to ensure we follow OS where possible."
Highlights of the data presented include:
A summary of the overall data compared to historical controls is shown
| Treatment | Number of patients | Median PFS (months) | Median OS (months) | 1-year survival (%) | 2-year survival (%) |
| Gemcitabine (ACCORD 11) (Conroy et al., 2011) | 171 | 3.3 | 6.8 | 20 | 2 |
| Gemcitabine (MPACT) (Von Hoff et al., 2013; Goldstein et al., 2015) | 430 | 3.7 | 6.6 | 22 | 5 |
| Gemcitabine/REOLYSIN (REO 017) | 33 | 4.0 | 10.2 | 45 | 24 |
Of the 29 patients evaluable for clinical response, one patient had a
partial response (PR), 23 had stable disease (SD) and five had progressive disease as their best response. This translated into
a clinical benefit rate (CBR) (complete response (CR) + PR + SD) of 83%.
"This is the second cancer where we have confirmed that PD-L1 is
upregulated in target tumors following our collaborators initial observations of PD-L1 upregulation in glioblastoma," said
Dr. Brad Thompson, President and CEO of Oncolytics. "We are currently analyzing archived samples from other completed
studies and current samples from ongoing studies to determine if this is a common effect to most cancers. A systemic viral therapy
that generally led to upregulation of PD-L1 would allow increased use of anti PD-L1 drugs in cancers where there is insufficient
PD-L1 to make therapy possible."
REO 017 is a U.S. Phase 2, single-arm clinical trial using intravenous
administration of REOLYSIN in combination with gemcitabine (Gemzar ) in chemotherapy-na ve
patients with advanced or metastatic pancreatic cancer. Eligible patients were treated with gemcitabine at 800 mg/m2
on days 1 and 8, and REOLYSIN at 1x1010 TCID50 administered IV on days 1, 2, 8 and 9 every
3 weeks. Tumor assessment was performed every two cycles. The trial enrolled 33 evaluable patients (34 total) using a one sample,
two-stage design. In the first stage, 17 patients were to be enrolled, and best response noted. If three or more responses
were observed (defined as CR, PR, or SD for 12 weeks or more) among the 17 patients, the study would enroll an additional 16 patients
for a total of at least 33 evaluable patients. As previously disclosed, this initial endpoint was met after six evaluable
patients were enrolled. The primary objective of the trial was to determine the CBR of intravenous multiple doses of REOLYSIN in
combination with gemcitabine in patients with advanced or metastatic pancreatic cancer. The secondary objectives were to determine
PFS, and to determine the safety and tolerability of REOLYSIN when administered in combination with gemcitabine.
A copy of the poster presentation will be available on the Oncolytics
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 Phase II single-arm clinical trial
in pancreatic 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: TMX Equicom, Nick Hurst, 300 5th Ave. SW, 10th
Floor, Calgary, Alberta T2P 3C4, Tel: 403.218.2835, Fax: 403.218.2830, nhurst@tmxequicom.com; TMX Equicom, Michael Moore, San Diego,
CA, Tel: 858.886.7813, mmoore@tmxequicom.com; 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 06:30e 06-JUL-15