BioCentury
ARTICLE | Clinical News

Oncolytics off on Phase III update

September 13, 2012 1:10 AM UTC

Shares of Oncolytics Biotech Inc. (TSX:ONC; NASDAQ:ONCY) fell on Wednesday after the company amended the Phase III REO 018 trial of IV Reolysin in combination with carboplatin and paclitaxel vs. chemotherapy alone in patients with head and neck cancer. The company said the changes could delay the report of progression-free survival data by at least three months and cause FDA to remove the trial's SPA. Oncolytics slid C$0.33 (12%) to C$2.40 on Wednesday. On NASDAQ, the stock fell $0.34 (12%) to $2.48.

Oncolytics doubled enrollment to 160 from 80 and plans to introduce a prospective segregation for subgroups of patients with local recurrent disease with or without metastases and patients with distal metastases. Additionally, Oncolytics will now conduct the second stage of REO 018 as a separate Phase III trial. The second stage was designed to use an adaptive design to allow for frequent data evaluation to determine the probability of reaching significance. ...