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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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April 20, 2015
06:36 EDTONCYOncolytics announces series of posters to be made at AACR Annual Meeting
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April 17, 2015
06:31 EDTONCYOncolytics receives ODD by FDA for Reolysin
Oncolytics Biotech announced that the FDA has granted an Orphan Drug Designation, or ODD, for its lead product candidate, Reolysin, for the treatment of malignant glioma. The company applied for an ODD for pediatric high grade gliomas, or HGG, however the FDA granted an ODD for the broader indication of malignant glioma in patients of all ages. In three previous brain cancer studies including gliomas, Reolysin has been shown to infect a variety of brain tumors when delivered intravenously.
April 16, 2015
09:14 EDTONCYOncolytics granted orphan status for malignant glioma treatment
The FDA granted Oncolytics orphan status for its treatment of malignant glioma, Reolysin. .
April 15, 2015
06:35 EDTONCYOncolytics Biotech's Reolysin shows positive results in pancreatic cancer
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06:34 EDTONCYOncolytics Biotech presents Reolysin data at UK Immuno-oncology meeting
Oncolytics Biotech announced that Dr. Matt Coffey, COO, made a presentation titled "Reolysin and Immune Therapy: Rationale for Combination Therapy" at the Royal Society of Medicine's Immuno-oncology: Using the Body's Own Weapons conference, held in London, UK. The presentation included data from a single arm clinical study examining the use of Reolysin in combination with gemcitabine in patients with advanced pancreatic cancer, PD-1 and PD-L1 up regulation data from a single arm clinical study examining the use of Reolysin in patients with primary glioblastomas or brain metastases, as well as preclinical data. Highlights of new data presented include: Clinical evidence that Reolysin treatment results in immunological changes to both the tumor cells and the tumor microenvironment that is conducive to novel immune targeting interventions; and Updated results from the REO 017 study, in which pancreatic cancer patients received combination therapy with Reolysin and gemcitabine demonstrated a median overall survival of 10.2 months, and one- and two-year survival rates of 45% and 24%, respectively.

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