Safety Study of a Fluorescent Marker to Visualize Cancer Cells

Inclusion criteria

• Male or female patients age ≥ 18 years.
• Known or suspected non-metastatic basal cell or squamous cell carcinomas ≥10 mm longest diameter or non-metastatic melanoma ≥6 mm longest diameter scheduled for excision, without advanced disease.
• Written Informed Consent.
• Agree to the use of effective contraceptive from Baseline and for 30 days after treatment if either male or female of child bearing potential.
• Available for and able to comply with study requirements.

Exclusion criteria

• Women who are lactating/breastfeeding
• Women with a positive pregnancy test or who are planning to become pregnant during the duration of the study.
• Life expectancy <6 months.
• Karnofsky Performance Status of ≤70%.
• The following laboratory abnormalities:

• Neutrophil count <1.5 x 10^9/L
• Platelets <75 x 10^9/L
• Haemoglobin <10 g/dL (may be determined following transfusion)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper limit of normal (ULN)
• Total bilirubin >2x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
• International Normalized Ratio (INR) >1.5
• Creatinine >1.5x ULN
• History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine and/or hospitalization.
• Uncontrolled asthma or asthma requiring oral corticosteroids.
• Clinically significant chronic inflammatory skin conditions, including psoriasis, atopic dermatitis and scleroderma, as determined by the investigator.
• Unstable angina, myocardial infarction, known or suspected transient ischemic events or stroke within 24 weeks of Screening.
• Uncontrolled hypertension.
• QTc (corrected QT interval) prolongation >450 msec.
• Receipt of photosensitising drugs within 30 days of screening.
• Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
• Any concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would impact adversely on the subject or the interpretation of the study data.
• Known or suspected sensitivity to study product or excipients.
• Prior participation in this clinical trial (has received study product).