Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its financial results for the three and nine-month periods ended September 30, 2009.
“In the third quarter, we passed a number of key milestones in our evolving REOLYSIN(R) development program, including making progress on a number of Phase II clinical initiatives and in manufacturing,” said Dr. Brad Thompson, President and CEO of Oncolytics. “Subsequent to quarter-end, we met our most important milestone to date in the advancement of our clinical program as we reached an agreement with the U.S. FDA on the design of a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers.”
Selected Third Quarter Highlights: During the quarter, the Company announced: – Conclusion of patient enrollment in the Phase II component of the Company’s U.K. REOLYSIN and paclitaxel/carboplatin clinical trial (REO 11); – Successful completion of the lyophilized (freeze-dried) formulation development program for REOLYSIN; – Successful completion of an initial 100-litre production run of REOLYSIN under cGMP conditions; – The grant of the Company’s 32nd U.S. Patent, # 7,582,289, entitled “Viruses for the Treatment of Cellular Proliferative Disorders” with the claims covering methods of using modified parapoxvirus orf virus to treat Ras-mediated cancers; – Acceleration of the warrant expiry date on warrants issued in connection with a financing completed in December 2008; and – The start of enrollment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN in combination with paclitaxel and carboplatin in patients with metastatic melanoma being conducted at the Cancer Therapy & Research Center at the University of Texas Health Science Center (CTRC). Latest Highlights Subsequent to quarter end, the Company announced: – An agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the design of a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers; – Acceleration of the warrant expiry date on warrants issued in connection with a financing completed in May 2009; – Grant of the Company’s 33rd U.S. Patent, # 7,608,257, entitled “Sensitization of Chemotherapeutic Agent Resistant Neoplastic Cells With a Virus.” The patent claims cover methods of using reovirus in combination with currently approved chemotherapeutic agents to treat patients that are refractory to those chemotherapeutic agents alone; – The results of the two warrant expiry date acceleration programs for warrants issued and amended in December 2008 and issued in 2009, generating proceeds of approximately $14.9 million.
Oncolytics Biotech Inc.