Oncolytics Biotech Inc. Announces Independent Data Monitoring Committee Recommends Continued Enrollment in Phase III Study of REOLYSIN® in Head and Neck Cancers Following Review of Safety Data
Published: Jun 20, 2012
“The safety data from the first stage of the Phase III study met our expectations and confirms the positive safety data from our other clinical studies using REOLYSIN,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We will now focus our time and attention on conducting the statistical analysis of the efficacy of the first stage’s patient population, which is forthcoming.”
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.
The study is a randomized, two-arm, double-blind, multi-centre, two-stage, adaptive Phase III trial assessing the intravenous administration of REOLYSIN with the chemotherapy combination of paclitaxel and carboplatin versus the chemotherapy alone in patients with metastatic or recurrent squamous cell carcinoma of the head and neck, or squamous cell cancer of the nasopharynx, who have progressed on or after prior platinum-based chemotherapy. On April 2, 2012, the Company announced that enrollment in the non-adaptive, 80-patient first stage of the trial had been completed. Enrollment is currently underway in the adaptive second stage, which is designed to enroll between 100 and 400 patients. This adaptive trial design allows data evolution to determine if the probably of reaching a statically significant endpoint has been achieved. The trial is currently being conducted at more than 80 centres in 14 countries in North America and Europe, including the United States following an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process with respect to the trial's design.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics’ clinical program includes a variety of human trials including a Phase III trial in head and neck cancers using REOLYSIN®, its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.