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news.Genticel, a French biotechnology company and leading developer of therapeutic vaccines, has announced that the enrollment of the Phase II RHEIA-VAC study has reached the halfway mark of its recruitment target.
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The study is on track with Genticel’s initial projections. All of the 39 investigation sites across seven European countries (Belgium, Finland, France, Germany, the Netherlands, Spain and the UK) are fully operational.
Furthermore, the Data and Safety Monitoring Board (DSMB), an independent committee of experts who monitor safety data every six months during the study, met as scheduled on July 1st and recommended pursuing the RHEIA-VAC study as planned.
Benedikt Timmerman, the founder and CEO of Genticel, said: "We are very satisfied with the progress of the study and with the involvement of our investigators, whose motivation has largely contributed to this progress. At this rate, we shall have completed all of our patient recruitment as projected, by the first semester of 2015."
RHEIA-VAC is a Phase II study of the ProCervix therapeutic vaccine. ProCervix is used for HPV 16 and/or 18 infected women, who have normal cervix cytology or ASCUS(1)/LSIL(2) (mild cervical cellular dyskaryosis). RHEAIA-VAC is a double-blinded, randomized and placebo-controlled efficacy study.
Viral clearance at 12 months is the primary endpoint. In a previous Phase I study, ProCervix showed a favorable safety and tolerability profile.