First ever light-activated, non-surgical treatment for HPV and pre-cancerous lesions of the cervix

A new non-surgical, tissue-preserving therapeutic procedure is being developed to more effectively remove HPV infection and treat precursors of cervical cancer.

“Thanks to advances in LED technology, which mean that controlled doses of light can be effectively delivered at specific wavelengths, we were able to develop a viable alternative.”

Cevira® is a drug-device combination procedure which has been accepted for use in a Phase II clinical trial by the US FDA. The trial will take place in multiple centers across the United States and Europe and is expected to start during the spring of 2011. Cevira is being developed by Photocure ASA, a Norwegian specialty pharmaceutical company focused in dermatology and cancer, with the help of Sagentia, its global product development partner, for the device. Cevira delivers a targeted light-activated treatment (also known as photodynamic therapy or PDT) intended to be used to destroy tissue infected by Human Papilloma Virus (HPV) and treat pre-cancerous lesions on the cervix, without damaging healthy tissue.

Unlike previous applications of PDT for the treatment of cancer, this is the first therapeutic treatment that uses advanced LED technology in a self-powered, disposable device which can be deployed inside a body cavity.

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 gynecologist 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 pre-cancer 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.

"This is the first ever non-surgical treatment for HPV and pre-cancerous lesions of the cervix to be successfully developed", comments 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 healthcare systems."

For the Cevira device, Photocure's request to Sagentia was to co-develop an easy-to-use device as an alternative to laser-based treatment.

"Photodynamic therapy is showing real potential as an effective modality in identifying and treating many forms of cancer," said Dr. Kjetil Hestdal, President and CEO of Photocure, "Sagentia's expertise in optics, electronics and medical device development enabled the design of an electronic cervical device which may be both safely deployed in the vagina and may effectively deliver the correct dosage of both pharmaceutical and light to the diseased area of the cervix."

"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," comments Brent Hudson, CEO of Sagentia. "Thanks to advances in LED technology, which mean that controlled doses of light can be effectively delivered at specific wavelengths, we were able to develop a viable alternative."

Following proof of concept, including clinical tests, and detailed design engineering, including optical design, electronic design, materials selection and design for assembly, Sagentia has on behalf of and in collaboration with Photocure developed a design suitable for clinical trials. Sagentia continues to work with Photocure on the manufacture for clinical trials and ongoing development.