Photocure initiates enrollment into phase II trial of Cevira® for cervical HPV infection
First study to evaluate optimal dose of novel integrated drug-delivery device
First novel therapeutic treatment option for highly prevalent cervical HPV infections and precancerous lesions
Oslo, Norway, 20 June - Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in cancer and dermatology, has initiated patient enrolment in the first trial to evaluate the optimal dose and safety of Cevira, a novel integrated intravaginal drug-delivery device.
The study is a randomized, placebo controlled dose finding study in patients with low to moderate grade cervical intraepithelial neoplasia (CIN 1-2). The main end-point in the study is to assess the histological confirmed response of Cevira 3 months after treatment. The trial will also evaluate the safety profile of the new intravaginal drug-delivery device. The trial will enroll 240 patients, at 21 centers, across the US and Europe. The study is designed to be the study that will form the platform for the final phase III program of Cevira, and the results of the trial are anticipated in the second half 2012.
Cervical HPV and precancerous lesions of the cervix are highly prevalent diseases affecting an estimated 260 million women across the globe, currently with no therapeutic treatment options available. Cevira is being developed as the first novel therapeutic option for this large and growing patient population. Cevira can be easily administered by gynecologists, obviating the potential morbidities associated with surgery. Clinical proof of concept has previously been demonstrated, with an excellent safety profile and no patient down time.
Kjetil Hestdal, President and CEO, states "There is a huge unmet medical need across the globe for a therapeutic alternative for CIN lesions and cervical HPV disease. By combining both the drug and light source into an integrated, easy to administer and highly tolerable system, the previous barriers to adoption of photodynamic technologies has been obviated, allowing for greater patient access by physicians."
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Notes to editors
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 mill 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 mill 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 the Cevira ointment with illumination by a red light source to treat HPV and cervical abnormalities. Cevira ointment 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 but 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 selected 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 markets Allumera, a photodynamic cosmetic in the US. 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(TM) platform.
Photocure®, Hexvix®, Cevira® and Allumera® 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)