Oncolytics Biotech Inc. Announces Overall and KRAS-Mutated Patient Data from U.S. Randomized Phase 2 Pancreatic Cancer Study TORONTO

Oncolytics Biotech Inc. Announces Overall and KRAS-Mutated

Patient Data from U.S. Randomized Phase 2 Pancreatic Cancer Study

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.

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

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

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

For further information:

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Calgary, Alberta T2P 3C4

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CO: Oncolytics Biotech Inc.

CNW 17:06e 16-SEP-14