CALGARY, Nov. 9, 2012 /PRNewswire/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced three poster presentations covering expanded results from: a Phase II clinical trial using intravenous administration of REOLYSIN in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumours (REO 016), a Phase II clinical trial using intravenous administration of REOLYSIN in combination with gemcitabine (Gemzar ®) in patients with advanced pancreatic cancer (REO 017), as well as preclinical research in Ras-activated pancreatic cancer. The presentations are being made at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics being held in Dublin, Ireland from November 6 th through 9 th, 2012.
"We continue to expand our library of positive clinical data in a variety of indications like lung and pancreatic cancers," said Dr. Brad Thompson, President and CEO of Oncolytics. "Positive results from these earlier studies have further validated our decisions to advance both these indications into randomized Phase II testing."
The poster presentation titled "Phase II Trial of Oncolytic Reovirus in Combination with Chemotherapy in NSCLC Pts with Kras Activated Tumors" covers the latest results from the REO 016 study. Thirty-three of a planned 36 patients had received Reovirus (REOLYSIN) (3 x 10 10 TCID 50) intravenously daily on days one to five, in combination with carboplatin and paclitaxel. Molecular tumor demographics included: 16 Kras, three EGFR, four BRAF mutations, and 10 EGFR amplified only. Response evaluation to date among 30 evaluable patients showed 27 patients had stable disease or better for a 90% clinical benefit rate (nine partial response (PR) (30%) and 18 stable disease (SD) (60%)). Three patients had progressive disease (PD) as their best response.
The poster presentation titled "A study of REOLYSIN in Combination with Gemcitabine in Patients with Advanced Pancreatic Adenocarcinoma" covers updated results from the REO 017 study. The trial is a 33-patient study 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 complete response (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 33 evaluable patients. As previously disclosed, this initial endpoint was met after six evaluable patients were enrolled and the study continued to enroll the total of 33 patients. The treatment was well tolerated. Response evaluation to date among 25 evaluable patients showed 20 patients had stable disease or better (one PR, one unconfirmed PR, 6 SD at six weeks, and 12 SD at 12 or more weeks). Five patients had PD as their best response. A number of patients remain on study with some too early in their treatments to evaluate.