Quest PharmaTech Announces Positive Results from Phase I Clinical Trial of its Photodynamic Therapy for Actinic Keratosis
"We are delighted to have received, for the first time, clinicalvalidation for our SonoLight Technology in a dermatological application," saidMadi R. Madiyalakan, CEO of Quest. "Actinic Keratosis is a pre-cancerous skincondition usually caused by prolonged accumulated sun exposure which canprogress to squamous cell carcinoma, a potentially life-threatening form ofskin cancer, unless treated by a dermatologist or other physician. This trialsuccessfully demonstrated that cutaneous photodynamic therapy (PDT) with SL017appears safe and is well tolerated. In addition, our unique approach isdesigned to overcome some of the limitations associated with othercommercially available PDT treatments for Actinic Keratosis."
Actinic Keratosis has a global incidence of approximately 10 to 15% in theCaucasian population and the American Medical Association estimates the U.S.market for the treatment of Actinic Keratosis to be about US $250 million.
The primary objective of the Phase I study, which was conducted in Canada,was to determine the cutaneous and systemic toxicity of the topically-appliedphotoactive drug, SL017, with and without photoactivation. The exploratoryobjective was to evaluate the efficacy of SL017 with and withoutphotoactivation in the treatment of Actinic Keratosis. The study parametersemployed included physician clinical assessment, patient symptomaticassessment, skin photography, blood chemistry, urinalysis, electrocardiogramand skin biopsy. The study was conducted at clinical sites in Edmonton andMontreal.
The study met all the objectives addressing the clinical safety endpoints.There were no observed clinically relevant adverse events associated with thetreatment at all the concentrations (0 to 40 mg of SL017) and light doses (10to 20 joules/cm(2)) administered. The light treatment, convenientlyadministered in a dermatology clinic, was well tolerated. The therapeuticpotential of SL017 was evidenced by the expected (PDT) effects, such asredness, edema, occasional blisters, stinging and burning. The clinicalcorrelates of dyskeratosis and inflammation were likewise appropriately notedon skin biopsy. Clinical and pathological results correlated very well, andconformed not only to the expected effects of PDT but also to the dosage ofthe drug and light energy administered. The study suggests that a 2% topicalformulation of SL017 and a fluence of 20 joules/cm (2) provide expected PDToutcomes. Importantly, this Phase I study did not identify any safety concernswith respect to the parameters evaluated at the dosages of drug and lightemployed.
"I am encouraged by the confirmation of the topical PDT effects of SL017and its potential for future applications in a variety of dermatologicalconditions including Actinic Keratosis," commented Dr. Gilles Lauzon, formerDirector, Division of Dermatology, University of Alberta and one of theinvestigators of the study.
The potential applications of cutaneous PDT also include acne, rosacea,superficial skin cancers, cutaneous T-cell lymphoma, localized scleroderma,warts, leishmaniasis and skin rejuvenation. Quest has already shown thefollicular uptake of SL017 in humans; and is currently conducting a 90-patienttrial addressing potential hair removal applications with results anticipatedby end of this year. The Company is also evaluating the utility of SL017 forthe treatment of acne in a preclinical model.
Paramount Biosciences, a global pharmaceutical and healthcare investmentfirm, has exclusive rights to develop and commercialize SL017 fordermatology-related applicatio
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