Dec. 13, 2012 - Oncolytics Biotech Inc. (ONC.TO, ONCY) moved sharply higher on Thursday on the announcement of Positive Top Line REOLYSIN® Data for First Endpoint in Randomized Phase III Study in Head and Neck Cancers. From the news release:
"The endpoint examines initial percentage tumour changes between the pre-treatment and first post-treatment scans (typically performed at six weeks post-first treatment) of all patients enrolled in the study. The analysis was designed to assess early differences in response between loco-regional tumours and metastatic tumours, as classified and observed by the investigators. This is the first, and to this point only, endpoint to be un-blinded for this study.
The first analysis compared the relative percentages of patients in the test and control arms with tumours that had either stabilized or exhibited shrinkage. For the purposes of this endpoint, the definition of tumour stabilization was restricted to zero percent growth only. Of the 105 total patients with evaluable metastatic tumours, 86 percent (n=50) of those in the test arm of the study exhibited tumour stabilization or shrinkage, compared with 67 percent of patients (n=55) in the control arm. This was statistically significant, with a p-value of 0.025.
The second analysis examined the magnitude of tumour response on a per patient basis using a comparison of percentage tumour shrinkage at six weeks in each patient with evaluable metastatic tumours. This analysis showed that REOLYSIN in combination with carboplatin and paclitaxel was statistically significantly better than carboplatin and paclitaxel alone at stabilizing or shrinking metastatic tumours, yielding a p-value of 0.03."
"To the best of our knowledge, this is the first successful double-blinded randomized data from a clinical study using an intravenously-administered oncolytic virus. We are delighted to have obtained statistically significant data for REOLYSIN in a randomized clinical setting," said Dr. Brad Thompson , President and CEO of Oncolytics. "We continue to await the data for the other endpoints of this study, to which all parties still remain blinded at this point."
This news bodes extremely well for the company as the biotech sector is very hot at the moment. Given their success at using REOLYSIN in conjunction with carboplatin and paclitaxel for shrinking the tumors at just 6 weeks into the study shows that the drug is a strong candidate for eventual FDA approval. With a market cap of only $230M, they become a prime candidate for a buyout for any company interested in cancer treatment. Further data endpoints in the Phase III study will provide investors with near-term stock price appreciation opportunities with the next one potentially being the 12-week endpoint six weeks away. Byron Capital maintains a $9 target price on ONCY.