The trial is proceeding as planned, after first DSMB (Data and Safety Monitoring Board) review
Genticel (Euronext Paris and Brussels: FR0011790542 - GTCL), a French biotechnology company and leading developer of therapeutic vaccines, announces today that the enrollment of the Phase II RHEIA-VAC study has reached the halfway mark of its recruitment target. The study is on track with Genticel's initial projections. All of the 39 investigation sites across 7 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."
About the clinical trial RHEIA-VAC (Research on HPV Eradication In Adults by VACcination):
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.
(1) ASCUS: Atypical Squamous Cells of Undetermined Significance
(2) LSIL: Low grade Squamous Intra-epithelial Lesions
Genticel is a French pharmaceutical company specialized in the development of therapeutic vaccines aimed at eliminating, at an early stage, the human papillomavirus (HPV) responsible for cervical cancer. Besides ProCervix, a second therapeutic vaccine candidate targeting six of the most pertinent strains of HPV is currently in preclinical stage. Vaxiclase, the technology platform, used in this product is ideally adapted for developing early-intervention immunotherapies against multiple infectious or cancerous diseases.
Genticel is based in Paris and Toulouse and was awarded the 2013 Innovation Prize by the 'Grands Prix de l'Economie'.
Since April 4, 2014, Genticel shares have been listed on the regulated Euronext markets in Paris and Brussels.
For more information, please visit Genticel's website www.genticel.com
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