Photocure is developing a non-surgical, tissue-preserving photodynamic therapy (PDT) procedure to remove human papilloma virus (HPV) infection and treat precursors of cervical cancer more effectively.
Cevira, a drug-device combination procedure developed with the help of Sagentia, delivers a targeted PDT treatment intended to destroy tissue infected by HPV and treat pre-cancerous lesions on the cervix, without damaging healthy tissue. This is the first PDT treatment that uses advanced LED technology in a self-powered, disposable device that can be deployed inside a body cavity. Cevira contains an LED light source that in combination with a medicinal product initiates a photochemical reaction in exposed tissue. The fully integrated, single-use device is administered by a trained gynecologist or colposcopist and is then left in place on the cervix up to 24 hours, during which time the patient is able to leave the hospital and continue with her daily activities, before removing and disposing of the device herself.
Cevira has been accepted for use in a clinical Phase II trial by the FDA. The trial will investigate this advanced form of PDT in patients with cervical pre-cancer as an alternative to current surgical procedures, such as laser therapy, surgical conisation, LEEP excision or cryotherapy (freezing). These can damage healthy tissue and cause long-term health issues, including post-surgical infections, reduced fertility and an impeded ability to carry a child full-term. The study will also investigate the suitability in treating patients with mild cervical abnormalities, as this new approach could be an alternative to the numerous and stressful follow-up examinations patients currently have to endure.
The trial will take place in multiple centers across the U.S. and Europe and is expected to start during spring 2011.
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Posted by Lee Mather
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