Two phase III studies on Metvix® PDT/Aktilite® finalised
Oslo Norway, 14 February 2007
Photocure has finalised two multicenter phase III studies comparing Metvix PDT to placebo using Photocure's light source Aktilite at leading clinical centres in the EU/US. The studies were conducted to obtain approval for Metvix in combination with Aktilite in the US (the trade name in the US is Metvixia(TM)).
The studies were conducted in 12 centres in the US and 8 centres in Germany. The two studies included 96 and 115 patients with 4-10 actinic keratosis (AK) lesions of grade 1 or 2 in the face or scalp. Metvix cream or placebo cream was applied for 3 hours prior to illumination with Aktilite. All patients received two treatments with one week apart, and were followed for 3 months.
Both studies showed significant better response in patients treated with Metvix than the one in the placebo group. These results are similar to the excellent results seen in earlier clinical studies with Metvix in combination with Curelight.
Kjetil Hestdal, President and CEO of Photocure comments: "These two studies will be the basis for submitting the supplemental New Drug Application (sNDA) for the Aktilite lamp in the US. Both studies are conclusive and confirmatory, and we have a good scientific foundation for our application."
Photocure ASA is a Norwegian pharmaceutical company listed on 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 aims to develop a pipeline of follow-on products and technologies.
For further information, contact:
Photocure ASA
Attn. Christian Fekete (CFO)
Phone: + 47 22 06 22 10
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 aims to develop a pipeline of follow-on products and technologies.
For further information, contact:
Photocure ASA
Attn. Christian Fekete (CFO)
Phone: + 47 22 06 22 10
Mobile + 47 91 64 29 38