Annually more than 400.000 Pap-smear samples are obtained from the Norwegian cervical screening program for detection of precancerous lesions, caused by persistent human papilloma virus (HPV) infections.
Written by Bjørn Klem, Project Director, Photocure ASA
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HPV infects 70-80% of all women (and men) and is very common in young women 18-25 years of age. Most HPV infections (~90%) are transient but persistent infections may induce cervical cell changes. Precancerous lesions are treated by surgical procedures to avoid progression to cervical cancer, but are associated with undesirable side effects including bleeding, infection, stenosis, infertility and preterm labour. Gynaecologists have for long been in need of a therapeutic alternative but so far no drug treatment has been effective.
Photocure Technology combines photosensitive drugs with light for diagnosis and treatment of patients with different disorders. This technology meets all requirements from the patients and gynaecologist, removing HPV and the cell changes selectively without harming the cervix.
Supported by the Norwegian Research Council, Photocure has patented and developed a novel intravaginal light source to be used together with the drug ointment. The gynaecologist easily applies the ointment and light source to the cervix (picture) and the patient may leave the gynaecologist office and continue normal daily activities. The patient will remove the device herself at the end of the day after completion of the treatment.
The intravaginal device contains a battery that runs LEDs providing red light. A microchip controls the photoactivation and the electronics is moulded in silicone with a string attached at the and to facilitate removal of the device.
Photocure has recently finalised the first feasibility study in Norway and started a large clinical study in 240 patients in Europe and US to document safety and efficacy. More than 200 patients have so far been treated with Cevira and the procedure works excellent, but waiting for the first results by end 2012.
Photocure aims at being the first company in the world to launch a therapeutic product for HPV and cervical precancer. Cevira is easy to use and meets a large medical need by replacing surgical procedures associated with undesirable side effects with a tissue preserving method. In addition, Cevira may be offered to patient with persistent HPV infection who have no access to treatment today. Photocure is currently looking for an R&D and commercial partner working in the field of gynaecology to maximise the business opportunity of Cevira.