A nonsurgical photodynamic therapy (PDT) procedure is being developed to destroy tissue infected by human papilloma virus (HPV) and treat precancerous lesions on the cervix without damaging healthy tissue. Unlike previous applications of PDT for the treatment of cancer, this drug device, called Cevira, is the first therapeutic treatment that uses advanced LED technology in a self-powered, disposable device that can be deployed inside a body cavity. Cevira 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 gynecologist or colposcopist and left in place on the cervix for up to 24 hours. During this time, the patient can leave the hospital and continue 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 conization and LEEP (loop electrosurgical excision procedure) 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 also will investigate the suitability of 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. “This is the first-ever nonsurgical treatment for HPV and precancerous lesions of the cervix to be successfully developed,” said Dr. Peter Hillemanns, professor and chairman at the Department of Obstetrics and Gynecology of Medical University Hannover, and principal investigator for the trial. “If this sophisticated breakthrough device is accepted, it will make way for a new era in cervical cancer treatment that will not only minimize patient risk and suffering, but could also help reduce the burden of HPV on health care systems.” Cevira is being developed by Photocure ASA, a Norwegian specialty pharmaceutical company focused in dermatology and cancer, with the help of Mass.-based Sagentia, its global product development partner for the device. The aim was to develop an easy-to-use device as an alternative to laser-based treatment. “We worked closely with Photocure to assess the feasibility of replacing existing laser treatments with a single-use disposable device that would be less invasive for the patient. The feasibility study took into consideration a variety of technical factors, as well as clinician input and patient needs,” said Brent Hudson, CEO of Sagentia. “Thanks to advances in LED technology, which means that controlled doses of light can be effectively delivered at specific wavelengths, we were able to develop a viable alternative.” Cevira has been accepted for use in a Phase II clinical trial by the FDA. The trial will take place in multiple centers across the US and Europe and is expected to start this spring. For more information, visit: www.photocure.com