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Photocure ASA (OSL:PHO) Six-month interim data presented at international conference addressing prevention of cervical cancer
Oslo, Norway, 17 November 2008 - Photocure presented positive interim data at the six-month follow up stage of its phase I/II clinical feasibility study with Cevira(TM) at the EUROGIN 2008[1] international conference. Cevira(TM) is Photocure's photodynamic therapy (PDT) in development as a new treatment of precancerous lesions of the cervix (CIN) induced by persistent human papilloma virus (HPV) infection.
The six-month clinical data from 35 patients in Norway showed that 73% patients with moderate grade lesions (CIN2) were treated successfully as determined by complete regression of lesions confirmed through a normal biopsy (histology) and cell sampling (cytology). 38% of patients with more severe (CIN3) lesions also responded positively to Cevira treatment.
A complete response of the lesions correlated with the eradication of HPV in 87% of the responding patients. Importantly, the treatment was well tolerated with cervical tissue preserved and completely normalized after PDT treatment.
Vaginal/cervical HPV infection is very common in women - 70-80% of women will experience HPV infection during their lifetime, with the highest incidence in the age group between 20 and 25 years. Development of precancerous lesions depends on virus type and persistence of infection. Local surgery (conization) is the preferred treatment of choice, but this treatment has complications including bleeding, infection, scarring and pre-term deliveries in subsequent pregnancies. There is therefore a medical need for a non-invasive therapeutic treatment of CIN.
Cevira PDT is being studied in women with cervical precancerous lesions who are eligible for surgery to remove the affected tissues, the current standard of care. The ongoing study involves 92 patients at two clinical centers in Germany and Norway, all of whom will be followed for 12 months after treatment.
Commenting on the interim results, Prof. Dr. Peter Hillemanns, Director of the Centre of Gynaecology at Hannover Medical School and lead investigator of the trial, said "Standard treatment of care for patients with cervical precancerous lesions is local surgery. The major disadvantage of this procedure is the substantial excision or destruction of cervical stroma, which may cause cervical insufficiency with pre-term delivery, low-birth-weight babies or cervical scar strictures. Photodynamic therapy (PDT) using Cevira represents a promising new non-invasive procedure with minimal side effects that preserves cervical function and can easily be performed on an out-patient basis".
Kjetil Hestdal, President and CEO of Photocure, said, "We are seeing a clear therapeutic benefit with Cevira PDT for treating precancerous cells in the cervix, particularly moderate grade CIN lesions, in the early data from this study. This novel form of treatment has the potential to treat patients with moderate grade CIN lesions effectively without risk of permanent damage to the cervix caused by surgery. We eagerly anticipate the conclusion of the study and further results that confirm these encouraging interim results as they will provide valuable input in the development of an optimal treatment for patients with abnormalities in the cervix."
For further comments, contact:
Photocure ASA Kjetil Hestdal, President & CEO (kh@photocure.no) Mobile: +47 913 19 535 Christian Fekete, CFO (cf@photocure.no) Mobile: +47 916 42 938
Photocure ASA is a Norwegian pharmaceutical company listed on Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices for the treatment and diagnosis of different types of cancer. The products are based on proprietary photodynamic technologies, targeting specific dermatology and oncology markets.
Photocure has currently two pharmaceutical products on the market: Metvix®, for the treatment of sun-damaged skin and certain types of skin cancer, and Hexvix®, for the diagnosis of bladder cancer. In addition, the company has developed a proprietary light source, the Aktilite® lamp, which is used in combination with the Metvix 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 and technologies.
[1] EUROGIN 2008 is an international gynecological meeting addressing prevention of cervical cancer, with more than 2000 participants attending (Nice, France, 12-15 November 2008) - www.eurogin.com
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