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.