Metvix(R) Photodynamic Therapy Trial Shows Superior Overall Treatment Compared to Surgery in Nodular Basal Cell Carcinoma (BCC)

Apr 19, 2001, 01:00 ET from PhotoCure ASA

    OSLO, Norway, April 19 /PRNewswire/ -- PhotoCure ASA today announced the
 completion of a European Phase III multicentre study, where more than
 100 patients with nodular basal cell carcinoma (BCC), a non-melanoma skin
 cancer, were treated either with photodynamic therapy (PDT) or surgery.  Both
 treatments gave high initial cure rates three months after treatment, with
 Metvix(R) PDT showing significant improvement in cosmetic outcome over
 surgery.
     Nodular BCCs are often thicker and more difficult to treat than
 superficial BCCs, and they occur more often in the face.  Metvix(R) PDT is a
 novel treatment which involves application of a cream, Metvix(R), that is
 absorbed only by cancer cells, and is subsequently activated by a proprietary
 red light source (Curelight), so that the cancer cells are selectively
 destroyed, leaving the normal skin to heal without scars.  Metvix(R) is
 pending approval in Sweden and Australia for pre-cancerous actinic keratosis
 and "high risk" BCC.
     After surgical excision, 98% of lesions disappeared completely, compared
 to 90% of the lesions treated with Metvix(R) PDT.  However, there was no
 statistically significant difference between the treatment groups.  In the
 cosmetically important facial lesions, the cure rates were 97% for surgery and
 95% for Metvix(R) PDT.  The cosmetic outcome was much better after Metvix(R)
 PDT than after surgery.  The dermatologists graded the cosmetic outcome as
 "good" or "excellent" in 83% of the patients treated with Metvix(R) PDT,
 versus only 15% in the surgery group.
     The side effects in both groups were mainly mild and transient, and none
 lead to treatment discontinuation or other medical interventions.
     Dr Lesley Rhodes of Manchester University, who was the lead investigator
 for this study, said:  "The Metvix(R) PDT trial is a breakthrough, as it is
 the first randomised multicentre study comparing topical PDT with the standard
 surgical treatment.  The new study demonstrates that a double treatment with
 Metvix(R) PDT, following careful lesional surface preparation, is close to
 surgery in achieving cure of skin cancers.  Treatment with Metvix(R) PDT
 however produces considerably improved cosmetic results compared with surgery,
 and can therefore be a suitable alternative particularly beneficial for
 cosmetically sensitive skin areas."
     PhotoCure President & CEO Vidar Hansson was also very pleased with the
 results and commented:  "The fact that this randomised study has shown the
 clear benefits of Metvix(R) PDT in the overall treatment of nodular BCC
 lesions, should increase significantly the commercial potential of this
 therapy."
 
     PhotoCure ASA is a Norwegian listed company founded in 1993.  PhotoCure
 ASA's mission is to develop and sell pharmaceuticals and medical devices based
 on proprietary photodynamic technologies.  The company is developing products
 for skin cancer and other skin diseases, internal cancer, gene therapy and
 cancer vaccines.  Metvix(R) and Curelight is developed for the treatment of
 basal cell carcinoma (skin cancer) and actinic keratosis (pre-cancerous skin
 lesions).  PhotoCure's second pharmaceutical product, Hexvix(R), is currently
 undergoing clinical trials for bladder cancer detection.  PCI Biotech AS is
 established as a subsidiary of PhotoCure ASA to develop and commercialise new
 transfection technologies for the research market as well as products in
 oncology and gene therapy.
 
 

SOURCE PhotoCure ASA
    OSLO, Norway, April 19 /PRNewswire/ -- PhotoCure ASA today announced the
 completion of a European Phase III multicentre study, where more than
 100 patients with nodular basal cell carcinoma (BCC), a non-melanoma skin
 cancer, were treated either with photodynamic therapy (PDT) or surgery.  Both
 treatments gave high initial cure rates three months after treatment, with
 Metvix(R) PDT showing significant improvement in cosmetic outcome over
 surgery.
     Nodular BCCs are often thicker and more difficult to treat than
 superficial BCCs, and they occur more often in the face.  Metvix(R) PDT is a
 novel treatment which involves application of a cream, Metvix(R), that is
 absorbed only by cancer cells, and is subsequently activated by a proprietary
 red light source (Curelight), so that the cancer cells are selectively
 destroyed, leaving the normal skin to heal without scars.  Metvix(R) is
 pending approval in Sweden and Australia for pre-cancerous actinic keratosis
 and "high risk" BCC.
     After surgical excision, 98% of lesions disappeared completely, compared
 to 90% of the lesions treated with Metvix(R) PDT.  However, there was no
 statistically significant difference between the treatment groups.  In the
 cosmetically important facial lesions, the cure rates were 97% for surgery and
 95% for Metvix(R) PDT.  The cosmetic outcome was much better after Metvix(R)
 PDT than after surgery.  The dermatologists graded the cosmetic outcome as
 "good" or "excellent" in 83% of the patients treated with Metvix(R) PDT,
 versus only 15% in the surgery group.
     The side effects in both groups were mainly mild and transient, and none
 lead to treatment discontinuation or other medical interventions.
     Dr Lesley Rhodes of Manchester University, who was the lead investigator
 for this study, said:  "The Metvix(R) PDT trial is a breakthrough, as it is
 the first randomised multicentre study comparing topical PDT with the standard
 surgical treatment.  The new study demonstrates that a double treatment with
 Metvix(R) PDT, following careful lesional surface preparation, is close to
 surgery in achieving cure of skin cancers.  Treatment with Metvix(R) PDT
 however produces considerably improved cosmetic results compared with surgery,
 and can therefore be a suitable alternative particularly beneficial for
 cosmetically sensitive skin areas."
     PhotoCure President & CEO Vidar Hansson was also very pleased with the
 results and commented:  "The fact that this randomised study has shown the
 clear benefits of Metvix(R) PDT in the overall treatment of nodular BCC
 lesions, should increase significantly the commercial potential of this
 therapy."
 
     PhotoCure ASA is a Norwegian listed company founded in 1993.  PhotoCure
 ASA's mission is to develop and sell pharmaceuticals and medical devices based
 on proprietary photodynamic technologies.  The company is developing products
 for skin cancer and other skin diseases, internal cancer, gene therapy and
 cancer vaccines.  Metvix(R) and Curelight is developed for the treatment of
 basal cell carcinoma (skin cancer) and actinic keratosis (pre-cancerous skin
 lesions).  PhotoCure's second pharmaceutical product, Hexvix(R), is currently
 undergoing clinical trials for bladder cancer detection.  PCI Biotech AS is
 established as a subsidiary of PhotoCure ASA to develop and commercialise new
 transfection technologies for the research market as well as products in
 oncology and gene therapy.
 
 SOURCE  PhotoCure ASA