Photocure - First phase II acne study finalized
Oslo, Norway, 29 September 2006
This phase IIA study is a dose selection study comparing 3 different doses of MAL cream and 4 different durations prior to light exposure in 43 patients with moderate to severe facial acne. MAL cream 160 mg/g applied for 3 hours before light exposure was compared with MAL cream of lower concentrations applied for shorter times before light exposure. The study was designed to select optimal dosing regimes for the phase II confirmatory dose response study which is planned to start in 2006.
The results showed that the efficacy with respect to the reduction in number of inflammatory lesions is maintained with lower cream concentrations and shorter times to light exposure. A similar reduction in lesion counts was seen across the different treatment groups after a single treatment. Side effects including pain during treatment and subsequent erythema were substantially reduced with the lower concentrations of MAL cream and shorter incubation times compared to MAL 160 mg/g, for 3 hours, the approved Metvix PDT treatment for AK and BCC.
The study was performed at two Canadian centres, with Dr Robert Bissonnette, Innovaderm Research, Montreal, as the main investigator.
Dr. Kjetil Hestdal, President and CEO of Photocure, comments: "This study brings the development of MAL PDT for treatment of acne an important step forward."
Acne is a common skin condition which affects up to 85% of adolescents. Of those who seek medical advice, about 50% have moderate and 20% have severe acne. Current therapies for these patients include oral antibiotics and isotretinoin, both products that may have significant adverse effects. There is thus a clear medical need for a safe and efficacious topical treatment for acne patients.
Photocure ASA is a Norwegian pharmaceutical company listed on the Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices based on proprietary photodynamic technologies, targeting key dermatology and oncology markets.
Photocure has two products with sales and marketing approvals: Metvix®, which is a product developed for the treatment of skin cancer (basal cell carcinoma) and pre-cancerous skin lesions (actinic keratosis), and Hexvix®, which is developed for the detection of bladder cancer. Both products are based on the same photodynamic technology, combining the drug known as a photosensitiser with a light source that activates the photosensitiser. Photocure is currently testing both products for new indications and aims to develop a pipeline of follow-on products and technologies.
For further information, contact:
Photocure ASA
Hoffsveien 48, NO-0377 Oslo, Norway - www.photocure.com
Christian Fekete (cf@photocure.no) - Mobile: +47 916 42 938