Oncolytics Reports Overall, KRAS-Mutated Patient Data from US Randomized Phase 2 Pancreatic Cancer Study

Oncolytics Biotech^® Inc.("Oncolytics") (NASDAQ: ONCY) today announced overall and KRAS-mutatedpatient 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 ormetastatic pancreatic cancer (NCI-8601). The trial is sponsored by the U.S.National Cancer Institute (NCI) through a clinical trials agreement betweenthe Cancer Therapy Evaluation Program, Division of Cancer Treatment andDiagnosis and Oncolytics. Oncolytics provided clinical supplies of REOLYSIN^®for the study and paid for the immune and genetic testing of the patients.Summary FindingsThe overall objectives of the study were to determine the progression freesurvival of the overall patient population and the patient populationaccording to KRAS mutation status.Overall patient populationThe study enrolled 73 patients; 37 were in the control arm, 36 were in thetest arm. The median progression free survival for the control arm was 5.16months (95% confidence interval (CI) = 2.267 to 6.176) versus 5.26 months forthe test arm (95% CI = 3.187 to 6.307) (see Figure 1).KRAS mutated patient populationAs part of the study design, patients were screened for KRAS status at codon12. Of the 60 patients where KRAS status could be determined (mutant vs wildtype), 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 5.72months (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 thecontrol arm. Three patients on the test arm and one on the control arm had notprogressed as of the time of analysis.Crossover patient populationPatients on the control arm who progressed on carboplatin and paclitaxel hadthe 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 aftercrossover were one partial response (PR), six stable disease (SD), sevenprogressive disease (PD), and two not evaluable, giving a disease control rate(complete response (CR) + PR + SD) of 50% in the carboplatin and paclitaxelfailed group."This is the first randomized clinical evidence that screening patients fortheir KRAS status could influence their clinical outcomes when treated with adrug regime that includes REOLYSIN^®," said Dr. Alan Tuchman, Senior VicePresident, Medical and Clinical Affairs & Chief Medical Officer of Oncolytics."These findings support previous evidence of REOLYSIN^® being active in cancercells with an activated RAS pathway and warrants confirmation of KRAS statusas a potential predictive biomarker in future studies."The study was an open-label, multi-institution, two-arm phase 2 randomizedstudy of patients with metastatic pancreatic cancer. Patients were randomizedto receive either carboplatin, paclitaxel plus REOLYSIN^® (test arm) orcarboplatin and paclitaxel alone (control arm). Patients in both arms receivedtreatment every three weeks (21-day cycles) and standard intravenous doses ofpaclitaxel and carboplatin on day one only. In the test arm, patients alsoreceived intravenous REOLYSIN^® at a dose of 3x10^10 TCID[50] on days onethrough five. Tumor response assessment was done by computed tomography (CT)scan and conducted every eight weeks. Patients who progressed on carboplatinand paclitaxel (control arm) had REOLYSIN^® added. If patients experiencedsignificant toxicity related to carboplatin and/or paclitaxel, they couldcontinue with single agent REOLYSIN^®.The primary endpoint of the trial is to assess improvement in progression-freesurvival with REOLYSIN^®, carboplatin and paclitaxel relative to carboplatinand paclitaxel alone in patients with metastatic pancreatic cancer. Theprimary endpoint is progression free survival in both arms. Secondaryendpoints include safety, overall response rate, overall survival, immunefactors and to prospectively establish and validate the relationship betweenRas mutations in tumor samples and response to REOLYSIN^®.Conference Call DetailsDr. Brad Thompson, President and CEO of Oncolytics, will host a conferencecall and webcast with slide presentation on Tuesday September 16, 2014, at4:30 p.m. MT (6:30 p.m. ET) to discuss in more depth the data from therandomized Phase 2 study in pancreatic cancer (NCI-8601). To access, the audioof the conference call by telephone, dial 1-647-427-7450 or 1-888-231-8191. Alive multimedia webcast will be available at the following link:http://event.on24.com/r.htm?e=852599&s=1&k=641116B118D98458B495B7FACA96A1F6 orthrough the Company's website athttp://www.oncolyticsbiotech.com/for-investors/presentations. Please connectat least 10 minutes prior to the webcast to ensure adequate time for anysoftware to download. A replay of the multimedia webcast will be available athttp://www.oncolyticsbiotech.com/for-investors/presentations and the audioportion will also be available by telephone through Tuesday September 23,2014. To access the telephone replay, dial 1-416-849-0833 or 1-855-859-2056and enter reservation number 6077886 followed by the number sign.