Cevira is in development as a local treatment for Cervical intraepithelial neoplasia lesions and human papilloma virus (HPV) of the cervix without damaging healthy tissue. With Cevira, Photocure aims to develop the first non-surgical treatment for precancerous cervical lesions using photodynamic therapy (PDT). Cevira treatment is administered locally and remains in contact with the cervix to deliver treatment for up to 24 hours. A cup holds the ointment against the cervix for initial absorption. After a few hours, a light source within the cup emits light at a specific wavelength so the Active Pharmaceutical Ingredient, hexylaminolevulinate (HAL), react with the tissue.
In the Phase IIa study with an external light source, Cevira 5% vaginal suppositories were applied for five hours followed by a light dose of 50 J/cm² to 70 patients. At six months, HPV lesions were completely cleared in 57% of women in the treatment arm as compared to 25% in the control group.
In a new feasibility study, the objective was to verify the safety and tolerability of administration and removal of the new device with an integrated light source and drug delivery system. In addition, patients were followed for six months for safety and efficacy. Results showed that the single-use drug-device was easily administered by the gynaecologist and well tolerated by the patients. Additionally, the study demonstrated encouraging early efficacy results, with 70% of patients having complete lesion response and 20% percent had partial response.
Cevira has completed clinical trial phase IIb development and is expected to enter phase III in 2013.