Oncolytics Biotech® Announces Third Quarter 2013 Results
Oncolytics Biotech Inc. has announced its financial results and operational highlights for the quarter ended September 30, 2013.
"In recent months we have reported positive data in our squamous cell and non-squamous cell lung clinical trials both in terms of tumour response and survival," said Dr. Brad Thompson, President and CEO of Oncolytics.
Dr. Thompson continued, "On the strength of this reported data, we intend to conduct randomized clinical studies in these indications that will further expand our lung cancer program."
Since June 30, 2013, the Company has made a number of announcements including:
Clinical Trial Results
• Reporting positive final results from a U.S. Phase 2 study examining the use of REOLYSIN® in combination with carboplatin and paclitaxel in patients with stage IV non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumors (REO 016).
Response evaluation for 36 evaluable patients showed 11 partial responses (PR) (30%) (EGFR amplified, five; BRAF two; Kras, three; EGFR mutated, one), 21 stable disease (SD), and four progressive disease (PD). The data also correlated a number of molecular abnormalities with best response, progression free survival (PFS) and one-year survival.
Current data in these patients demonstrates that 20 of 36 evaluable patients (56%) survived a year or more. There were 13 patients with only EGFR mutations or amplifications, of whom nine (69.2%) survived a year or longer. Four of four (100%) patients with BRAF and EGFR amplification survived a year or longer; and
• Reporting final tumour response and progression free survival ("PFS") data from a U.S. Phase 2 clinical trial in patients with squamous cell carcinoma of the lung (SCCLC) using intravenous administration of REOLYSIN® in combination with carboplatin and paclitaxel (REO 021).
Of the 25 evaluable patients who had more than one cycle of therapy, 23 (92%) exhibited overall tumour shrinkage. When evaluated for best response, which is the best percentage response recorded on study compared to baseline, 10 patients (40%) had partial responses (PRs), while a further 14 (56%) showed stable disease (SD), and one (4%), had progressive disease (PD).
Using RECIST criteria to evaluate best overall response, 10 patients (40%) had partial responses (PRs), 12 (48%) showed stable disease (SD) and three (12%), had progressive disease (PD). 31.8% of patients with sufficient follow up had a PFS greater than six months.