Oslo, Norway, September 30, 2013: Cevira® recently completed a successful phase 2b study in patients with cervical precancerous lesions (CIN2) and Photocure is currently preparing for a phase 3 clinical program. The data from the phase 2b study showed that Cevira® was highly efficient in treating high grade precancerous lesions of the cervix as well as treating the underlying infections with Human Papillomavirus (HPV). Cevira® results also showed that treatment with Cevira® was highly tolerable and well received by the patients and physicians. The clinical data was presented on Saturday 28th September by Dr Philipp Soergel at a German Colposcopy meeting in Cologne. Dr Soergel, who has been part of the clinical trial program, commented on the data: “ I see Cevira® as a very exciting opportunity as a novel treatment for patients with persistent oncogenic HPV infections and cervical precancerous lesions, as Cevira® offers an easy, safe and tissue-preserving procedure in these women.”
Link to the meeting and program
For further information, please contact:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: firstname.lastname@example.org
CFO Erik Dahl
Tel: +47 50 55 000, Email: email@example.com
Mary Clark, Amber Bielecka, Hollie Vile
Tel: +44 207920 2361, Email: firstname.lastname@example.org
About HPV infection and cervical abnormalities
Persistent HPV infection may cause cervical precancer with a risk of development to cancer. Screening programs are initiated to find women with cellular abnormalities who will be followed up or treated to prevent development of cervical cancer. Standard treatment of precancer is surgery but with increased risk of side effects including preterm labour, scarring that may impair fertility, infection and bleeding, which is undesirable particularly in young women in their reproductive age. In Europe and US approximately 1 million women are diagnosed with cervical precancer annually. Women with mild cervical abnormalities are followed up frequently with gynaecological examinations to prevent progression to precancer. The majority of cervical lesions regress spontaneously, but treatment may be offered in the persistent conditions. In Europe and US approximately 7 million women are diagnosed with mild cervical abnormalities annually.HPV prophylactic vaccines have recently been introduced to young girls but will have limited short-term effects on the number of patients developing precancer. HPV tests are being introduced to the market to address patients at high risk and will most likely be included in the public screening program. There is a medical need for a tissue preserving treatment modality in patients with cervical precancer. Patients with persistent HPV infection and mild abnormalities have a low risk of progression but all patients need frequent examinations to rule out progression to precancer. A treatment modality to eliminate the persistent HPV infection is desirable.
Cevira® is a photodynamic therapy that combines application of a drug with illumination by a red light source to treat HPV and cervical abnormalities. The drug contains HAL (hexaminolevulinate) which is applied together with the light source to the cervix. After a drug incubation time red light photoactivation starts and stops automatically, all within 10 hours. The treatment is administered by the gynaecologist and the patient may continue normal daily activities. The PDT procedure removes cervical abnormalities while preserving the normal tissue. Photocure has patents in cervical disease until 2030.
Photocure is a Norwegian pharmaceutical company listed on the Oslo Stock Exchange (OSE: PHO). The company develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and dermatology indications. Photocures commercial activities includes own marketing and sales in selected markets as well as out-licensing to leading pharmaceutical companies on a regional or global basis prior to phase III. Photocure has one proprietary pharmaceutical product on the market: Hexvix®, for the diagnosis of bladder cancer. Hexvix is approved in EU and in the US. In addition, the company has developed a proprietary light source, which is used in combination with the Visonac™ cream. Through worldwide studies, Photocure is continuously testing its products for new indications, and the aim is to develop a pipeline of follow-on products based on the Photocure Technology™ platform. Photocure® and Hexvix® are registered trademarks of Photocure ASA.
For more information about Photocure, visit our website at www.photocure.com.
This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)