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April 8, 2014
06:35 EDTONCYOncolytics Biotech announces additional data from REO 018 study of Reolysin
Oncolytics Biotech announced additional data from the company's randomized, double-blinded clinical study examining Reolysin in combination with carboplatin and paclitaxel in patients with second-line, platinum-refractory, taxane-na´ve head and neck cancers, or REO 018. The REO 018 study enrolled a total of 167 patients. Patients on the control arm were treated with carboplatin, paclitaxel and a placebo, while those on the test arm were treated with carboplatin, paclitaxel and Reolysin. Data was available for 165 patients, and was analyzed on an intent-to-treat basis.118 patients had loco-regional head and neck disease, with or without distal metastases. As previously disclosed, under these study conditions, test arm patients in this group had a progression-free survival, or PFS, benefit over control arm patients through five cycles of therapy. An intent-to-treat analysis of the 118 loco-regional patients using Type II censoring from the median PFS in each arm showed a statistically significant improvement in PFS for the test arm versus the control arm. An intent-to-treat analysis of the overall survival, or OS, of the 118 patients with loco-regional disease was performed on all patients to the median PFS in each arm, censoring any patients who received post-discontinuation therapy at the date at which they commenced the first of these therapies. This analysis demonstrated a statistically significant improvement in OS for the test arm versus the control arm. The 118 patients with loco-regional head and neck disease, with or without distal metastases, were evaluated for percentage magnitude of tumor shrinkage at the first post-treatment scan. The test arm demonstrated statistically significantly better tumor stabilization or shrinkage than the control arm.
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October 24, 2014
17:15 EDTONCYOncolytics Biotech enters $20M 'at-the-market' equity distribution agreement
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