--Report Near Tripling of Two-Year Survival
Compared to Historical Controls--
CALGARY,
Aug. 27, 2015 /PRNewswire/
- Oncolytics Biotech® Inc. ("Oncolytics")
(TSX:ONC) (NASDAQ:ONCY) today announced that Dr. Miguel A. Villalona-Calero will make an oral
presentation at International Association for the Study of Lung
Cancer (IASLC) 16th World Conference on Lung Cancer on
September 9, 2015. The presentation,
titled "Oncolytic Reovirus in Combination with
Paclitaxel/Carboplatin in NSCLC Patients with Ras Activated
Malignancies, Long Term Results," covers updated results, including
longer-term survival data, from the Company's REO 016 Phase 2 study
in Non-Small Cell Lung Cancer (NSCLC).
"Our research collaborators are noting the
two-year survival data from this study, which is high for
later-stage patients with recurrent or metastatic disease," said
Dr. Matt Coffey, COO of Oncolytics.
"As with our REO 017 clinical study that treated pancreatic cancer
patients with gemcitabine and REOLYSIN®, there was a
clear overall survival benefit with apparent limited impact on
progression free survival, which is generally characteristic of
immune involvement in outcomes."
Highlights of the data to be presented
include:
- A survival analysis for 37 Stage IV patients showing a median
progression free survival (PFS) of four months and median overall
survival (OS) of 13.1 months;
- One- and two-year survival rates of 57% and 30%, respectively,
with the authors concluding that the survival of 11 patients longer
than two years was substantial; and
- Seven patients remaining alive after a median follow up of 34.2
months (range 26.9-71.5 months), with two patients showing no
evidence of disease progression to date (50 and 37 months).
For comparison, the Company is referring to
historical control data as per Schiller et al., 2002, which
reported a median PFS of 3.1 months, median OS of 8.1 months,
one-year survival rates of 34%, and two-year survival rates of 11%.
There were 290 patients treated with carboplatin and paclitaxel,
86% of which were Stage IV and 14% Stage IIIB.
Of the 35 patients evaluable for clinical
response in the REO 016 study, 11 patients (5 Kras mutant)
had a partial response (PR), 20 had stable disease (SD) and four
had progressive disease by RECIST for an objective response rate
(ORR) of 31%. Four patients with SD had a >40% PET standardized
update value reduction after two cycles, yielding an ORR
considering PET of 43%.
REO 016 is a U.S. single arm, two-stage,
open-label, Phase 2 study of REOLYSIN® given
intravenously with paclitaxel and carboplatin every three weeks.
Patients received four to six cycles of paclitaxel and carboplatin
in conjunction with REOLYSIN®, at which time
REOLYSIN® may have been continued as a monotherapy. As
previously disclosed, the primary objectives of the trial were to
determine the ORR of REOLYSIN® in combination with
paclitaxel and carboplatin in patients with metastatic or recurrent
NSCLC with Kras or EGFR-activated tumours, and to measure
PFS at six months. The secondary objectives were to determine the
median survival and duration of PFS in patients, and to evaluate
the safety and tolerability of REOLYSIN® in combination
with paclitaxel and carboplatin in this patient population.
A copy of the abstract will be available on the
Oncolytics website at:
http://www.oncolyticsbiotech.com/for-investors/presentations and is
also available on the conference website at:
https://content.webges.com/library/wclc/browse/search/8Ej#2yv3H09C.
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 NSCLC, 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
applicable laws.
SOURCE Oncolytics Biotech Inc.