Genticel Completes Procervix Phase II Study Enrollment Ahead of Schedule
News Nov 15, 2014
Genticel has announced the completion of patient enrollment of the phase II study of its lead therapeutic vaccine candidate, ProCervix.
Completion of patient enrollment for the RHEIA-VAC study ahead of schedule
With the last patient enrolled on November 10, 2014, Genticel has reached a significant milestone in the ProCervix development program. Overall, 239 patients were enrolled at 39 sites across seven European countries (Belgium, Finland, France, Germany, the Netherlands, Spain and the UK) in less than ten months.
Since the beginning of 2014, Genticel has been running a double-blind, randomized,
placebo-controlled, multicenter trial for ProCervix, a therapeutic vaccine designed for adult women infected with HPV 16 and/or HPV 18, before high-grade cervical lesions or cancer occur. It is the first therapeutic vaccine to address the medical need of this high-risk population since preventive HPV vaccines cannot cure women from an established infection.
Sophie Olivier, the company’s chief medical officer, said: “We are very satisfied with the way the recruitment phase of the study has been carried out. Our RHEIA-VAC study investigators have been extremely efficient in enrolling patients meeting the eligibility criteria. As a result, we were able to complete the enrollment at least four months in advance. So far, only one out of all patients, having received a first vaccination, has decided to withdraw from the trial. This illustrates how determined these women are to get treated when they are infected by HPV 16 and/or HPV 18. It also seems to indicate that ProCervix has an acceptable safety and tolerance profile.”
Benedikt Timmerman, Genticel’s chief executive officer, added, “The amount of time to recruit patients in a clinical trial often represents the most significant operational uncertainty. With the completion of enrollment of the RHEIA-VAC phase II clinical trial, this uncertainty is behind us; we now have a fixed duration up to the completion of the study. Specifically, this means that the primary end point results by group will become available during the 1st half of 2016 instead of during the 2nd half, as previously forecast.”