Genticel Announces Further Trials
Edison | Jun 29, 2016 01:39AM ET
Genticel (PA:GTCL) has announced 18-month data from the Phase II trial of the GTL001 vaccine to treat early-stage human papillomavirus 16 and 18 infections (HPV16/18). In this update, GTL001 showed no statistically significant difference in any subgroup.
Safety remains positive. Genticel will present 24-month data in Q117, which will include the full data set and inform next steps. The company continues leveraging its Vaxiclase platform in collaboration with the Serum Institute of India (SIIL) and plans to expand its pipeline. We have revised our valuation down to €2.31/share (€5.75/sh previously) as we have cut the probability of success for GTL001.
18-month Phase II data released
Genticel has announced further data from its Phase II trial in HPV16/18 positive women. After 18 months, neither the predefined nor the post-hoc groups showed a statistically significant viral clearance rate vs placebo.
Although GTL001 has shown biological activity, it has missed significance due in part to the small number of patients. In consequence, the company will wait until the full data set is available at 24 months, which is expected in Q117. Notably, no safety issues have arisen.
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