A new non-surgical, tissue-preserving therapeutic procedure is being developed to more effectively remove HPV infection and treat precursors of cervical cancer. Photocure, a Norwegian specialty pharmaceutical company focused in dermatology and cancer, announced recently that the FDA has granted permission to start Phase II clinical studies in the US with Cevira, a drug-device combination procedure, in women with low-grade precancerous lesions of the cervix.
Cevira has the potential to offer patients and gynecologists’ an easy, safe and highly selective treatment, thus preserving normal surrounding tissue. The procedure combines hexaminolevulinate (HAL) ointment with a red light LED-source in a fully integrated disposable delivery system.
Cervical HPV-induced lesions affect seven million women in Europe and the US each year. Current treatment of precancerous lesions involves invasive surgical procedures to remove the precancerous lesions, which can result in the unnecessary removal of normal cervical tissue. Besides discomfort and recovery time, this can affect the patient’s ability to carry a child full-term, impact fertility and increase the risk of post-surgical infections. For a large number of patients with persistent HPV infections and low-grade cellular abnormalities, there are no currently available non-surgical treatment alternatives, and frequent follow up visits to avoid further disease progression causes patient anxiety and adds to the burden for the health care system.
The clinical trials will take place in multiple centers across the United States and Europe and are expected to start during the spring of 2011. The trials will investigate this advanced form of photodynamic therapy in patients with cervical pre-cancer as an alternative to current surgical procedures, such as laser therapy, surgical conization, LEEP excision or cryotherapy (freezing).