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news.Photocure, a leader in photodynamic technologies, has concluded patient enrollment in the Phase IIb dose-finding study of Cevira, a novel integrated intravaginal drug-delivery device.
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The randomized double blind placebo controlled trial enrolled a total of 240 patients with low to moderate grade cervical intraepithelial neoplasia (CIN1-2) to evaluate the optimal dose of the intravaginal drug-delivery device.
In the trial, primary treatment response will be assessed by central review of histology, cytology and HPV assessments 3 months after treatment with follow-up of 9 months.
The study results are expected in second half 2012 and will support the design of the pivotal Phase III registration program for the US and Europe.
Photocure president and CEO Kjetil Hestdal said they are happy that patient recruitment has completed on time, underlining the large interest in solving an unmet medical need in this population.