Quest PharmaTech Announces Positive Results from Phase I Clinical Trial of its Photodynamic Therapy for Actinic Keratosis
TSX Venture: QPT
EDMONTON, June 2 /PRNewswire-FirstCall/ - Quest PharmaTech Inc. (TSX-V:
QPT), ("Quest" or the "Company"), today announced that its 12-patient,
Phase I clinical study entitled "ACP-SL017 Topical Gel: A Phase I Study for
the Photodynamic Therapy of Actinic Keratosis" has met both its primary and
exploratory objectives.
"We are delighted to have received, for the first time, clinical
validation for our SonoLight Technology in a dermatological application,"
said Madi R. Madiyalakan, CEO of Quest. "Actinic Keratosis is a
pre-cancerous skin condition usually caused by prolonged accumulated sun
exposure which can progress to squamous cell carcinoma, a potentially
life-threatening form of skin cancer, unless treated by a dermatologist or
other physician. This trial successfully demonstrated that cutaneous
photodynamic therapy (PDT) with SL017 appears safe and is well tolerated.
In addition, our unique approach is designed to overcome some of the
limitations associated with other commercially available PDT treatments for
Actinic Keratosis."
Actinic Keratosis has a global incidence of approximately 10 to 15% in
the Caucasian 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-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 parameters employed included physician clinical
assessment, patient symptomatic assessment, skin photography, blood
chemistry, urinalysis, electrocardiogram and skin biopsy. 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 study suggests that a 2% topical formulation of SL017 and
a fluence of 20 joules/cm (2) provide expected PDT outcomes. Importantly,
this Phase I study did not identify any safety concerns with respect to the
parameters evaluated at the dosages of drug and light employed.
"I am encouraged by the confirmation of the topical PDT effects of
SL017 and its potential for future applications in a variety of
dermatological conditions including Actinic Keratosis," commented Dr.
Gilles Lauzon, former Director, Division of Dermatology, University of
Alberta and one of the investigators 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 the
follicular uptake of SL017 in humans; and is currently conducting a
90-patient trial addressing potential hair removal applications with
results anticipated by end of this year. The Company is also evaluating the
utility of SL017 for the treatment of acne in a preclinical model.
Paramount Biosciences, a global pharmaceutical and healthcare
investment firm, has exclusive rights to develop and commercialize SL017
for dermatology-related applications outside Canada. Paramount Biosciences
is conducting Investigational New Drug-enabling pre-clinical studies to
initiate a clinical trial for dermatology applications that will meet U.S.
Food and Drug Administration requirements for one or more indications.
Quest will coordinate with Paramount Biosciences for the further
development of SL017.
Quest is also pleased to announce that it has retained The Equicom
Group Inc. (Equicom) to provide the Company with strategic investor
relations and corporate communications services. Under the terms of the
agreement, Quest will pay Equicom a monthly retainer fee of $5,000 for
professional services. The initial contract term is 12 months. Neither
Equicom nor any of its principals has an ownership interest, directly or
indirectly, in Quest or its securities, and Quest has not granted Equicom
or its principals any right to acquire such an interest. Equicom is a
wholly-owned subsidiary of TSX Group Inc. Equicom provides strategic
communications services to more than 100 public companies across a diverse
range of industries. For further information about Equicom, please visit
www.equicomgroup.com.
About Quest PharmaTech Inc.
Quest PharmaTech is a publicly traded (TSX Venture Exchange: QPT),
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 SonoLight photodynamic and sonodynamic therapy platform.
TSX Venture Exchange has neither approved nor disapproved of the
information contained herein.
SOURCE Quest PharmaTech Inc.
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