Oncolytics BiotechÂ® Inc. Collaborators To Present Positive Phase 2 REOLYSIN Clinical Data In Pancreatic Cancer At The AACR-NCI-EORTC Molecular Targets And Cancer Therapeutics Conference
CALGARY, Nov. 14, 2011 /PRNewswire/ - Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics") today announced that interim results from a Phase 2 clinical trial using intravenous administration of REOLYSIN ® in combination with gemcitabine (Gemzar ®) in patients with advanced pancreatic cancer will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. The conference is being held in San Francisco, CA from November 12 th to 16 th, 2011.
The poster, entitled "A Phase II Study of REOLYSIN ® in Combination with Gemcitabine in Patients with Advanced Pancreatic Adenocarcinoma", authored by Mita et al, indicated that as of the date of submission of the poster that 12 patients were evaluable for response. All patients except one reported symptomatic improvement. Seven patients had stable disease (SD) for 12 weeks or longer, for a clinical benefit rate (complete response (CR) + partial response (PR) + SD) of 58%.This included two patients who had SD for 36 weeks or longer. An additional patient had an unconfirmed PR of less than six weeks. The treatment was well tolerated with manageable adverse events.
This study is using a one sample, two-stage design. In the first stage, 17 patients were to be enrolled, and best response noted. If less than three responses (defined as CR or PR or SD for 12 weeks or more) were observed, the study would have concluded that the combination was inactive and been terminated. If three or more responses were observed among the 17 patents, the study would enroll an additional 16 patients for a total of 33 evaluable patients. As previously disclosed, this endpoint was met after six evaluable patients were enrolled. If at least eight responses are observed out of 33 patients, the study will conclude that the drug combination is active. This study will be updated if and when this endpoint is reached.
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