CALGARY, May 7, 2015 /PRNewswire/ - Oncolytics Biotech® Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results and operational highlights for the quarter ended March 31, 2015.
“In the first quarter, we obtained Orphan Drug Designation from the U.S. FDA and the EMA in Europe for a number of different indications, which will support future development of REOLYSIN®,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We also reported a range of clinical and preclinical data that furthered our understanding of how REOLYSIN® works and the specific benefits it can confer in combination with other approved therapies.”
Selected Highlights
Since January 1, 2015, selected highlights announced by the Company include:
Clinical Program
- Completion of patient enrollment in an ongoing, NCIC Clinical Trials Group sponsored randomized Phase II study of REOLYSIN® in patients with advanced or metastatic colorectal cancer (IND 210). The Company awaits preliminary data from this study;
- Presentation of data from a single arm clinical study examining the use of REOLYSIN® in combination with gemcitabine in patients with advanced pancreatic cancer (REO 017);
- Presentation of data showing up regulation of PD-1 and PD-L1 from a single arm clinical study examining the use of REOLYSIN® in patients with primary glioblastomas or brain metastases (REO 013b) at the Royal Society of Medicine’s Immuno-oncology: Using the Body’s Own Weapons conference, held in London, UK;
Regulatory
- Application for Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for REOLYSIN® in the treatment of gastric cancer. The Company was granted designations by the FDA in ovarian, fallopian tube, primary peritoneal and pancreatic cancers as well as malignant glioma;
- Granting of Orphan Drug Designation by the European Medicines Agency for REOLYSIN® in the treatment of ovarian cancer, and subsequent to quarter end, for pancreatic cancer;
- Subsequently, on May 5, 2015, the Company was granted Orphan Drug Designation from the FDA for the treatment of gastric cancer;
Basic Research
- Presentation of clinical and preclinical data at the 2015 Immune Checkpoint Inhibitors meeting in Boston, MA, including content showing the combination of REOLYSIN®, GM-CSF, anti-PD-1 and anti-CTLA-4 improved survival in immune competent mice versus REOLYSIN® and GM-CSF alone and REOLYSIN® and GM-CSF plus either one of the checkpoint inhibitors alone;
- A series of presentations made by the Company’s research collaborators at the AACR Annual Meeting held in Philadelphia, PA covering preclinical research in a range of indications, with a variety of treatment combinations including REOLYSIN®; and
Financial
At March 31, 2015 the Company reported $30.6 million in cash, cash equivalents and short-term investments.
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