Oslo, Norway October 4th 2010: Photocure (OSE: PHO), a Norwegian specialty pharmaceutical company focused in dermatology and cancer, announces today promising initial results in a Phase II study of Cevira™ in treatment of patients with mild cervical abnormalities.
Photocure is developing Cevira™ for the non-surgical treatment of cervical HPV infection and precancerous lesions of the cervix. Cevira™ is a photodynamic therapy that combines a drug formulation with a medical device and offers the potential for an easy, quick and safe treatment procedure for patients with mild cervical abnormalities.
The preliminary results from a multi-centre placebo controlled Phase II study of 70 patients with mild cervical abnormalities showed a three month response rate of 71% for Cevira™ versus 43% in the control group. No serious side effects were reported. Cevira™ was administered as a vaginal suppository for five hours followed by photoactivation of 50J/cm2 using a laser system. These results support the efficacy/clinical benefit of Cevira™ in patients with low-grade cervical lesions as the first therapeutic product in this field. The final six months follow up data will be made available Q1 2011.
Standard treatment of precancerous lesions is surgery and is associated with an 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. Women with mild cervical abnormalities are followed up frequently with gynaecological examinations to prevent progression to precancerous lesions. A majority of cervical lesions regress spontaneously, but treatment may be offered in the persistent conditions. In Europe and US approximately 7 million women per annum are diagnosed with mild cervical abnormalities, with a million women diagnosed with precancerous cervical lesions.
A new Cevira™ medical device, treatment procedure and clinical development plan was presented to FDA last week. The outcome of this meeting was positive and Photocure plans to test the new device and procedure in clinical trials by the end of 2010. The new device will provide both gynaecologists and patients with a user-friendly and single-use treatment.
"Cevira™ will be an excellent alternative to invasive and costly follow up visits known to cause notable patient anxiety, and a potential therapeutic for non-compliant patients with a risk of not returning for gynaecological check-ups. These results are an encouragement to continue product development in this indication and patient population." says Dr. Kjetil Hestdal, President and CEO of Photocure.
For further information, please contact
President & CEO
Phone: + 47 913 19 535
CFO Christian Fekete
Phone: + 47 916 42 938
Mary Clark, Justine Lamond and Hollie Vile
Ph: +44 (0)20 7307 5337
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)