Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium

A Phase II, Multicentre, Double-blind, Placebo Controlled, Pilot Study to Evaluate the Safety and Efficacy of CUV1647 (Afamelanotide) as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium

The purpose of this study was to evaluate the safety and efficacy of afamelanotide (previously developed as CUV1647) as adjunctive therapy in patients undergoing photodynamic therapy using porfimer sodium.

Inclusion Criteria:

• Male or female Caucasian subjects undergoing photodynamic therapy with porfimer sodium;
• Aged greater than 18 years;
• Written informed consent prior to the performance of any study-specific procedure.

Exclusion Criteria:

• Known allergy or hypersensitivity to afamelanotide or the polymer contained in the implant;
• Non-Caucasian patients;
• Personal history of melanoma or dysplastic nevus syndrome;
• Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions;
• Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating;
• Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device);
• Participation in a simultaneous clinical trial for another investigational agent or within 30 days prior to the screening visit;
• Patients unable to give informed consent;
• Patient needs for concomitant medication with potential photosensitizing effects e.g. antibiotics like tetracyclines.