SL017 For Actinic Keratosis (AK) – Phase I Clinical Trial Completed

AK is a skin condition which affects individuals, especially fair-skinned, that have been over-exposed to sunlight during their lifetime. The AK lesions are scaly and raised and can be quite disfiguring, especially when on the face and scalp. More importantly, AK is considered to be a pre-malignant form of squamous cell carcinoma, and periodic monitoring and removal of lesions is necessary to avoid malignancy. Quest PharmaTech believes that SL017 will be a potential treatment for AK and has completed a Phase I clinical trial with this indication.

The primary objective of the Phase I study, which was conducted in Canada, was to determine the cutaneous and systemic toxicity of the topically-applied photoactive drug, SL017, with and without photoactivation. The exploratory objective was to evaluate the efficacy of SL017 with and without photoactivation in the treatment of Actinic Keratosis. The study was conducted at clinical sites in Edmonton and Montreal.

The study met all the objectives addressing the clinical safety endpoints. There were no observed clinically relevant adverse events associated with the treatment at all the concentrations (0 to 40 mg of SL017) and light doses (10 to 20 joules/cm(2)) administered. The light treatment, conveniently administered in a dermatology clinic, was well tolerated. The therapeutic potential of SL017 was evidenced by the expected (PDT) effects, such as redness, edema, occasional blisters, stinging and burning. The clinical correlates of dyskeratosis and inflammation were likewise appropriately noted on skin biopsy. Clinical and pathological results correlated very well, and conformed not only to the expected effects of PDT but also to the dosage of the drug and light energy administered. The Phase I study did not identify any safety concerns with respect to the parameters evaluated at the dosages of drug and light employed.

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