CALGARY, March 16, 2015 /PRNewswire/ - Oncolytics Biotech® Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results and operational highlights for the year ended December 31, 2014.
“The activities of the Company in 2014 have laid the groundwork enabling us to plan and execute our late stage clinical strategy,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We are looking forward to finalizing the plans for and initiating our registration studies for REOLYSIN®.”
Selected Highlights
Since January 1, 2014, 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;
- Reporting completion of enrollment and interim overall and KRAS-mutated patient data from an NCI-sponsored randomized Phase II study of REOLYSIN® in combination with carboplatin and paclitaxel in patients with recurrent or metastatic pancreatic cancer (NCI-8601). The Company awaits final data from this study, which will be available once all remaining patients have progressed;
- Completion of patient enrollment in an ongoing, NCI-sponsored randomized Phase II study of REOLYSIN® in combination with paclitaxel in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer (GOG-186H). The Company awaits preliminary data from this study;
- Reporting final 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-naïve head and neck cancers;
- Presentation by the Company’s collaborators of preliminary clinical data demonstrating that intravenously delivered REOLYSIN® can cross the blood brain barrier to access tumours in the brains of humans;
Regulatory
- Application for Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for REOLYSIN® in the treatment of ovarian and pancreatic cancers. The Company was granted designations in ovarian, fallopian tube, primary peritoneal and pancreatic cancer subsequent to year end;
- Application to the European Medicines Agency for Orphan Designation for REOLYSIN® in the treatment of pancreatic and ovarian cancers;
- Subsequent to year end, the Company applied to the U.S. FDA for a fifth Orphan Drug Designation for high grade gliomas in paediatric patients;
Basic Research
- Presentation of a poster entitled “Combination Therapy with Reovirus and PD-1 Blockade Effectively Establishes Tumour Control Via Innate and Adaptive Immune Responses” by the Company’s research collaborators, Vile et al., at the AACR Tumor Immunology and Immunotherapy Conference;
- A series of presentations made by the Company’s research collaborators at the 8th Annual International Conference on Oncolytic Virus Therapeutics held in Oxford, UK, covering:
- Preclinical research examining the synergies associated with treatment in animal models with GM-CSF prior to administering REOLYSIN®;
- Preclinical research focused on identifying biomarkers predictive of sensitivity/resistance to reovirus in head and neck cancer cell lines; and
- Preclinical research into the treatment of hepatocellular carcinoma associated with infection by Hepatitis B and Hepatitis C;
Governance
- The nomination and election of Ms. Linda Hohol and Ms. Angela Holtham to the Company’s Board of Directors;
Financial
- Entry into and subsequent amendments to a share purchase agreement with Lincoln Park Capital Fund, LLC;
- Entry into a $20 million “At-the-Market” equity distribution agreement with Canaccord Genuity Inc.; and
At December 31, 2014 the Company reported $16.2 million in cash, cash equivalents and short-term investments.
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