EDMONTON, June 25 /PRNewswire-FirstCall/ - Quest PharmaTech Inc. , (“Quest” or the “Company”), today announced interim results from its Phase I/II clinical study designed to investigate appropriate treatment parameters for the potential use of its proprietary compound SL017 for hair removal applications. The interim results represent data from the first 80 patients enrolled in the targeted 100-patient clinical trial.
“The Phase I/II interim results demonstrated that SL017 is safe and well tolerated when used either alone or in combination with photo activation,” said Madi Madiyalakan, Chief Executive Officer of Quest. “These results, along with results from the previous clinical trial, support the utility of SL017 for hair removal applications, especially for those who do not benefit from light treatment alone.”
To permanently remove unwanted hair, existing laser hair removal techniques require four to eight treatments, and provide only a 75 to 85 percent permanent hair reduction in a limited patient population. The professional laser hair removal market is estimated to be $5 billion worldwide.
Quest is developing SL017 photodynamic therapy (PDT) as a potential hair removal solution that is effective across a broad patient population including those with light colored hair (for example, grey or blonde hair). In a Phase I clinical trial, Quest demonstrated the preferential localization of SL017 in hair follicles, which suggested that cutaneous PDT with SL017 has potential for permanent hair removal applications.
The Phase I/II trial of SL017 was designed to evaluate the effect of skin treatment on follicular uptake of SL017, assess the tolerable light dose on healthy subjects, and subsequently, determine the efficacy of hair removal under optimal treatment conditions. Results from this study will be used to guide the design of future clinical development.
Skin Pretreatment and Follicular Uptake
Thirty healthy subjects were enrolled to evaluate the efficacy of five different skin preparation techniques to enhance the follicular localization of SL017. One of the five skin pretreatments demonstrated a statistically significant improvement in both the intensity of follicular uptake of SL017 and the depth of penetration of SL017 in the hair follicle compared to the other skin pretreatments.
Light Dose Escalation
Forty subjects with dark colored hair and 10 subjects with light colored hair were enrolled to evaluate the safety and efficacy of combining SL017 with increasing doses of Intense Pulse Light (IPL) ranging from 4.5J/cm(2) to 20.0J/cm(2). No skin pretreatment technique was used. No unexpected side effects were observed at any of the light doses tested. A hair count was taken at days 0 and 42 in each population. There was no statistically significant improvement in hair count reduction observed in the subjects treated with SL017 PDT compared to IPL treatment alone at any of the IPL doses or in either of the two hair populations studied. However, 25% of the dark colored hair population, or 10 subjects, that were non-responsive to IPL treatment demonstrated a statistically significant reduction in hair count when treated with SL017 PDT.
Hair Removal Efficacy Under Optimal Conditions
Quest is currently enrolling 20 additional patients, 10 with dark colored hair and 10 with light colored hair, to evaluate the efficacy of SL017 PDT compared to IPL at the optimal light dose and after skin pretreatment. The 20 subjects with light colored hair enrolled in the trial will also undergo two SL017 PDT treatments. The hair growth of these patients will be monitored for up to six months. Results from this part of the study are anticipated by end of 2008.
“Based on the results we receive from these clinical studies in hair removal and the preclinical work we are currently conducting for the treatment of acne, we intend to advance SL017 PDT for one or more clinical indications,” stated Thomas Woo, M.Sc., Vice President for Drug Development of Quest.
The Principal Investigator for Quest’s Phase I/II hair removal trial is Dr. Robert Bissonnette, M.D., President of Innovaderm Research in Montreal.
About SL017: SL017 is a proprietary, non-toxic drug that, once applied to a target area and activated by light, is transformed into a potent cytotoxic agent that selectively destroys targeted tissue. Using this process, known as photodynamic therapy (PDT), SL017 can be applied to treat a variety of skin conditions, including hair removal, actinic keratosis and acne. The safety and potential utility of SL017 for the treatment of actinic keratosis has been demonstrated in a Phase I Clinical Study.
About Quest PharmaTech Inc.: Quest is a publicly traded, Alberta-based pharmaceutical company committed to the development and commercialization of new pharmaceutical products. It is developing a series of products for the treatment of cancer and dermatological conditions based on its unique photodynamic and sonodynamic therapy platform.
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information herein.”
CONTACT: Dr. Madi R. Madiyalakan, Chief Executive Officer, Quest
PharmaTech Inc., Tel: (780) 448-1400 Ext. 204, Email:
madi@questpharmatech.com, Internet: www.questpharmatech.com; Investor
Relations - Adam Peeler, The Equicom Group Inc., Tel: (416) 815-0700 Ext.
225, E-mail: apeeler@equicomgroup.com
