Cevira, a photodynamic therapy device and hexaminolevulinate ointment combination product from Photocure (Oslo, Norway), is moving right along Phase II clinical trials for the treatment of Human Papilloma Virus (HPV). The package is inserted into a woman’s cervix where it stays active for an entire day, applying both light and ointment to the affected tissue. The device, which was developed with help from Sagentia (Cambridge, Massachusetts), has received FDA approval to continue with Phase II trials.
The Cevira device contains a LED light source that in combination with a medicinal product initiates a photochemical reaction in exposed tissue. The fully integrated single-use device is easily administered by a trained gynaecologist 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.
The clinical trials will investigate this advanced form of photodynamic therapy in patients with cervical precancer 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.