The trial continues as originally planned, following the first meeting of the Monitoring and Monitoring Committee (DSMB - Data and Safety Monitoring Board).
Genticel, a French biotechnology company specializing in the development of therapeutic vaccines, today announced that it has already recruited half the patients in its RHEIA-VAC Phase II study, in full compliance with the company's projections. The 39 research sites in seven European countries (Germany, Belgium, Spain, Finland, France, the Netherlands and the United Kingdom) are actively participating in this clinical trial.
In addition, the "Data and Safety Monitoring Board" (DSMB), which brings together the independent expert group, which reviews the tolerance data from the " After its meeting which was held as scheduled on 1 July, recommended the continuation of the trial without change.
"We are very satisfied with the progress of our study and with the strong involvement of the investigators who contributed greatly to this result," says Benedikt Timmerman, Chairman of the Management Board and Founder of Genticel. "At this rate, we should have completed, as expected, the recruitment of patients in the first half of 2015."
About RHEIA-VAC (Research on HPV Eradication In Adults by VACcination):
RHEIA-VAC is a Phase II study evaluating the ProCervix therapeutic vaccine. ProCervix is ??tested in women infected with either or both of the two oncogenic HPV 16 and HPV 18 strains with normal cervical cytology or 'ASCUS * / LSIL **' (cytological abnormalities of Low grade). RHEAIA-VAC is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of ProCervix. The primary objective of the study is viral clearance at 12 months. In the initial Phase I study, ProCervix showed a favorable tolerance profile.
(1) ASCUS: Atypical Squamous Cells of Undetermined Significance
(2) LSIL: Low grade Squamous Intra-epithelial lesions
About GENTICEL
GENTICEL is a French biopharmaceutical company specializing in the development of therapeutic vaccines to eliminate the human papillomavirus (HPV), an agent responsible for cervical cancer, at an early stage. In addition to ProCervix, a second candidate therapeutic vaccine, targeting the six most relevant HPV strains, is currently in preclinical phase. Vaxiclase, the technological platform used for this product is perfectly suited for strategies of early intervention in immunotherapy against multiple pathologies infectious or tumor.
Based in Paris and Toulouse, GENTICEL has been awarded the Innovation Prize for the 2013 Grands Prix de l'Economie.
GENTICEL shares have been listed on the regulated markets of Euronext in Paris and Brussels since 4 April 2014.
Genticel : 50% of patients recruited for the ProCervix Phase II Study
Genticel
