Norwegian specialty pharmaceutical company Photocure and Sagentia have received US Food and Drug Administration (FDA) approval to initiate Phase II clinical trial on Cevira, a drug-device being developed to treat Human Papilloma Virus (HPV) infection and precursors of cervical cancer. The trial will begin in multiple centres across the US and Europe during the spring this year.
Cevira delivers a light-activated treatment known as photodynamic therapy to destroy tissue infections caused by HPV and treat precancerous lesions on the cervix without affecting healthy tissue.
Cevira contains a LED light source in combination with a drug that initiates a photochemical reaction in exposed tissue.
The device can be administered by a trained gynaecologist or colposcopist and is left in the cervix up to one-day, during which time the patient can leave the hospital and continue with her daily activities, allowing the patient remove and dispose the device herself.
The trials will evaluate the photodynamic therapy in patients with cervical pre-cancer as an alternative to laser therapy, surgical conisation, LEEP excision or cryotherapy and investigate treatment suitability in patients with mild cervical abnormalities.