TORONTO,
Sept. 16, 2014 /CNW/ - Oncolytics
Biotech® Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY)
today announced overall and KRAS-mutated patient data from a
two-arm randomized phase 2 study of carboplatin, paclitaxel plus
REOLYSIN® (test arm) versus carboplatin and paclitaxel
alone (control arm) in the first line treatment of patients with
recurrent or metastatic pancreatic cancer (NCI-8601). The trial is
sponsored by the U.S. National Cancer Institute (NCI) through a
clinical trials agreement between the Cancer Therapy Evaluation
Program, Division of Cancer Treatment and Diagnosis and Oncolytics.
Oncolytics provided clinical supplies of REOLYSIN® for
the study and paid for the immune and genetic testing of the
patients.
Summary Findings
The overall objectives of the study were to determine the
progression free survival of the overall patient population and the
patient population according to KRAS mutation status.
Overall patient population
The study enrolled 73 patients; 37 were in the control arm, 36 were
in the test arm. The median progression free survival for the
control arm was 5.16 months (95% confidence interval (CI) = 2.267
to 6.176) versus 5.26 months for the test arm (95% CI = 3.187 to
6.307) (see Figure 1).
Figure 1 - Kaplan-Meier plot of the Progression
Free Survival (PFS) of the control arm versus the test arm of the
overall patient population. See Figure 1 link at bottom of this
release.
KRAS mutated patient
population
As part of the study design, patients were screened for KRAS status
at codon 12. Of the 60 patients where KRAS status could be
determined (mutant vs wild type), 44 (73%) had mutations in the
KRAS gene (n = 23 in the control arm, n = 21 in the test arm).
Median progression free survival in the test arm was 5.72 months
(95% CI = 3.187 to 6.767) versus 4.11 months in the control arm
(95% CI = 1.938 to 6.176) (see Figure 2). This translates into a
1.61 month (39%) improvement in median progression free survival in
the test arm versus the control arm. Three patients on the test arm
and one on the control arm had not progressed as of the time of
analysis.
Figure 2 - Kaplan-Meier plot of the Progression
Free Survival (PFS) of the control arm versus the test arm
of the KRAS mutated patient population. See Figure 2 link at
bottom of this release.
Crossover patient population
Patients on the control arm who progressed on carboplatin and
paclitaxel had the option of adding REOLYSIN® to their
regimen. At the time of the analysis, 16 patients crossed over to
the test arm regime. The best responses after crossover were one
partial response (PR), six stable disease (SD), seven progressive
disease (PD), and two not evaluable, giving a disease control rate
(complete response (CR) + PR + SD) of 50% in the carboplatin and
paclitaxel failed group.
"This is the first randomized clinical evidence
that screening patients for their KRAS status could influence their
clinical outcomes when treated with a drug regime that includes
REOLYSIN®," said Dr. Alan
Tuchman, Senior Vice President, Medical and Clinical Affairs
& Chief Medical Officer of Oncolytics. "These findings support
previous evidence of REOLYSIN® being active in cancer
cells with an activated RAS pathway and warrants confirmation of
KRAS status as a potential predictive biomarker in future
studies."
The study was an open-label, multi-institution,
two-arm phase 2 randomized study of patients with metastatic
pancreatic cancer. Patients were randomized to receive either
carboplatin, paclitaxel plus REOLYSIN® (test arm) or
carboplatin and paclitaxel alone (control arm). Patients in both
arms received treatment every three weeks (21-day cycles) and
standard intravenous doses of paclitaxel and carboplatin on day one
only. In the test arm, patients also received intravenous
REOLYSIN® at a dose of 3x1010
TCID50 on days one through five. Tumor response
assessment was done by computed tomography (CT) scan and conducted
every eight weeks. Patients who progressed on carboplatin and
paclitaxel (control arm) had REOLYSIN® added. If
patients experienced significant toxicity related to carboplatin
and/or paclitaxel, they could continue with single agent
REOLYSIN®.
The primary endpoint of the trial is to assess
improvement in progression-free survival with REOLYSIN®,
carboplatin and paclitaxel relative to carboplatin and paclitaxel
alone in patients with metastatic pancreatic cancer. The primary
endpoint is progression free survival in both arms. Secondary
endpoints include safety, overall response rate, overall survival,
immune factors and to prospectively establish and validate the
relationship between Ras mutations in tumor samples and response to
REOLYSIN®.
Conference Call Details
Dr. Brad Thompson, President and CEO
of Oncolytics, will host a conference call and webcast with slide
presentation on Tuesday September 16,
2014, at 4:30 p.m. MT
(6:30 p.m. ET) to discuss in more
depth the data from the randomized Phase 2 study in pancreatic
cancer (NCI-8601). To access, the audio of the conference call by
telephone, dial 1-647-427-7450 or 1-888-231-8191. A live multimedia
webcast will be available at the following link:
http://event.on24.com/r.htm?e=852599&s=1&k=641116B118D98458B495B7FACA96A1F6
or through the Company's website at
http://www.oncolyticsbiotech.com/for-investors/presentations.
Please connect at least 10 minutes prior to the webcast to ensure
adequate time for any software to download. A replay of the
multimedia webcast will be available at
http://www.oncolyticsbiotech.com/for-investors/presentations and
the audio portion will also be available by telephone through
Tuesday September 23, 2014. To access
the telephone replay, dial 1-416-849-0833 or 1-855-859-2056 and
enter reservation number 6077886 followed by the number sign.
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 NCI-8601 randomized Phase 2 study of
REOLYSIN in combination with carboplatin and paclitaxel in patients
with pancreatic cancer, 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 statement 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.
Image with caption: "Figure 1 - Kaplan-Meier plot of the
Progression Free Survival (PFS) of the control arm versus the test
arm of the overall patient population (CNW Group/Oncolytics Biotech
Inc.)". Image available at:
http://photos.newswire.ca/images/download/20140916_C9192_PHOTO_EN_42792.jpg
Image with caption: "Figure 2 - Kaplan-Meier plot of the
Progression Free Survival (PFS) of the control arm versus the test
arm of the KRAS mutated patient population (CNW
Group/Oncolytics Biotech Inc.)". Image available at:
http://photos.newswire.ca/images/download/20140916_C9192_PHOTO_EN_42793.jpg