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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.
News For ONCY From The Last 14 Days
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February 18, 2015
06:41 EDTONCYOncolytics Biotech completes enrollment of randomized Phase II study of REOLYSIN
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06:37 EDTONCYOncolytics Biotech completes enrollment in Phase II colorectal cancer study
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February 17, 2015
06:40 EDTONCYOncolytics Biotech receives ODD from FDA for REOLYSIN
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06:36 EDTONCYOncolytics Biotech granted Orphan Drug Designation for REOLYSIN by FDA
Oncolytics Biotech announced that the FDA has granted Orphan Drug Designation for its lead product candidate, REOLYSIN, for the treatment of pancreatic cancer. REOLYSIN is Oncolytics' proprietary isolate of the reovirus. Its primary mode of activity is to infect and selectively target tumours with activating Ras pathway mutations and/or over-expressions of Ras pathway elements including, amongst others, EGFR, BRAF and KRAS.

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