Genticel: A Deeper Look Into Phase II Data
Edison | Jun 07, 2016 08:50AM ET
Genticel (PA:GTCL) has announced further analysis of its Phase II results on the GTL001 vaccine to treat early-stage human papillomavirus (HPV) 16 and 18 infections. The pre-specified group of patients with normal cytology had a significantly higher viral clearance than those taking placebo (p=0.018). Post-hoc analysis of the combined group of normal and ASCUS patients also shows a statistically significant difference (p=0.0029) between groups. In our view, this indicates that GTL001 could be effective in 80% of women positive for HPV 16/18. Management expects 18-month data in Q316 to enable partnering and Phase III initiation.
Phase II data
The double-blind, placebo-controlled Phase II study reported on 233 patients (27% normal, 28% atypical squamous cells of undetermined significance or ASCUS and 45% low-grade lesion or LSIL). The 12-month primary endpoint of viral clearance in the overall population showed no significant difference to placebo (48.7% vs 39.7%, p=0.188, Fisher).
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