Replies to post #147416 on Biotech Values

[pcrutch]

From the company’s June 20th DMC safety review,

“The study design stipulates that the study will proceed to full enrollment in Stage 2 (ranging from 100 to 400 additional patients) provided that the DMC concludes that safety data in Stage 1 is acceptable for continuation to Stage 2, and an independent statistical analysis of Progression-Free Survival (PFS, a measure of efficacy) in Stage 1 predicts probability of success in Stage 2. The data collection for this analysis is currently being performed.

The safety analysis was performed on the 80 patients enrolled in Stage 1 of the study, once every patient had sufficient follow up after starting treatment on the study (six weeks). The statistical analysis will be performed once every patient has had sufficient follow up after starting treatment (12 weeks) to determine potential differences in PFS between the control and test arms of the study.”

ONCY does not plan to release OS data from this.

[pcrutch]

The statistician looks at the single (unblinded - all 80 patients) curve and compares these data to the data expected from a very well performing (upper percentile survival/progression) historical "control" group.

This doesnt seem accurate. How exactly are they measuring predictive success? Believe the company quoted 70% as a cutoff. Seems like a risky proposition. They dont even stratify by HPV status or RAS mutational status.

REO 018: Go/No Go Analysis
• The decision whether to continue enrolling in the second stage of the
study will be based upon a two stage analysis:

1. A safety evaluation by an independent Data Safety Committee (DSC),
based on first scan (6 weeks) post initiation of treatment data for all 80
patients from the first stage. The DSC met on June 19, 2012.

2. An evaluation of the predictive probability of success in the second
stage, to be performed by an independent statistician. This evaluation
will be based on second scan (12 weeks) post initiation of treatment data
for all 80 patients from the first stage.

2012 AGM slides
http://oncolytics.s3.amazonaws.com/presentations/33/original.pdf?1340230047

[pcrutch]

Also, where are the results of the REO 015 study in the US?

http://clinicaltrials.gov/ct2/show/NCT00753038?term=REOLYSIN+neck&rank=2