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news.French biotechnology firm Genticel has completed patient enrollment in the Phase II trial (RHEIA-VAC) of its lead therapeutic vaccine candidate, ProCervix , to treat human papillomavirus (HPV).
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A total of 239 subjects infected with HPV 16 and/or 18 were enrolled at 39 clinical sites across seven European countries including Belgium, Finland, France, Germany, the Netherlands, Spain and the UK.
Since the beginning of 2014, the company has been running a double-blind, randomized, placebo-controlled, multicenter RHEIA-VAC trial for ProCervix to treat adult women infected with HPV 16 and/or HPV 18, before high-grade cervical lesions or cancer occur.
Genticel chief medical officer Dr Sophie Olivier said: "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."
The company claims that ProCervix 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.
Genticel CEO Benedikt Timmerman said: "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 forecasted."