Breakthrough Light-Activated Drug-Device to be Investigated for Treatment of HPV* and Cervical Pre-cancer

Advanced photodynamic therapy may offer non-invasive alternative to laser treatment and freezing of damaged cells and help reduce long term burden on healthcare systems

CAMBRIDGE, Mass.--(EON: Enhanced Online News)--A new non-surgical, tissue-preserving therapeutic procedure is being developed to more effectively remove HPV infection and treat precursors of cervical cancer.

“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”

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.

About Cevira

Cevira is a combination product which combines the Cevira ointment with illumination by a red light source to treat HPV and cervical abnormalities. The Cevira ointment contains HAL (hexaminolevulinate) which is applied together with the light source to the cervix.

The Cevira device is being developed by Photocure together with Sagentia and is being used in Photocure’s Phase II clinical studies in multiple centers across the US and Europe. Photocure retains all intellectual properties and commercial rights to Cevira ointment, device and the combined use of the two.

The integrated product is self-contained and self-powered and is intended to be fitted inside the vaginal cavity in contact with the cervix for a period of ten hours, during which time the therapy is delivered.

The treatment procedure is as follows:

• The device is fitted to the cervix by a trained healthcare professional (gynaecologist/colposcopist).
• The cup in the device is used to hold the drug (ointment) against the cervix for an initial absorption period.
• A light source integrated into the cup emitting light at the appropriate wave length is automatically activated after a few hours of drug application and delivers the required dose of illumination.
• The Cevira device is removed by the patient at home and discarded.

About Photodynamic Therapy

Photodynamic therapy (PDT) is a treatment that uses a drug, called a photosensitizer or photosensitizing agent, and a particular type of light. Photosensitizers based on aminolevulinic acid (e.g. HAL) accumulate specifically in diseased tissue (e.g. tumors) and when exposed to a specific wavelength of red light, they produce reactive singlet oxygen that induce cell death in diseased tissue.

Each photosensitizer is activated by light of a specific wavelength. This wavelength determines how far the light can travel into the tissue. Thus, doctors use specific photosensitizers and wavelengths of light to treat different areas of the body with PDT.¹

About Sagentia

Sagentia is a global innovation, technology and product development company providing outsourced R&D consultancy services to start ups through to global market leaders in the medical, industrial and consumer sectors. With global headquarters in Cambridge, UK, and US headquarters in Cambridge, Massachusetts, Sagentia works with clients from front end market needs analysis through to transfer to manufacture. It delivers innovation around new technologies and new generation products and services that provide commercial value and market advantage. The company also assists business leaders to create strategies for technology, innovation and growth. Sagentia's resources are situated in state-of-the-art facilities in Europe, the U.S., and China. Information about Sagentia and its services can be found at www.sagentia.com.

About Photocure

Photocure ASA is a worldwide leader in photodynamic therapy. Listed on the Oslo Stock Exchange (OSE: PHO), Photocure develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications. The company strives to solve unmet needs by developing new and innovative solutions based on its patented Photocure Technology™. Photocure markets and sells its own products in selected markets and has developed strong partnerships with leading pharmaceutical companies on a regional and global basis. Photocure’s bladder cancer diagnostic product, Hexvix® is approved in the European Union and the US under the tradename of Cysview®. Setting new standards for diagnosis and treatment of several different conditions, Photocure Technology™ is very selective, targeting only diseased cells and preserving healthy tissue. Photocure Technology™ is being tested for new products and indications including acne, improving the appearance of skin (Allumera™), diagnosing colon cancer (Lumacan® which is outlicensed to Salix Pharmaceuticals) and the treatment of pre-malignant cervical lesions (Cevira®).

Photocure®, Cevira®, Lumacan®, Cysview® and Hexvix® are registered trademarks of Photocure ASA.

Photocure, Inc. is the marketing and sales subsidiary of Photocure ASA in the US. It is located in Princeton, NJ.

For more information about Photocure, visit their website at www.photocure.com.

¹ National Cancer Institute, Photodynamic Therapy, accessed at http://www.cancer.gov/cancertopics/factsheet/Therapy/photodynamic on Feb. 11,2011.