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This trial follows a number of pre-clinical studies that demonstrated bothan increase in dermal absorption of retinoic acid when formulated withPhosphagenics' proprietary drug delivery platform (TPM), and a significantreduction in irritation scores. The clinical trial is a double blinded studythat will involve 90 subjects and is being conducted at Broomall, PA-basedcyberDERM Inc., a contract research organization focused on developing andrefining innovative bio-instrumental and computerized methods for non-invasiveanalysis of skin structure, its functions and effects of topical treatments.This trial is expected to be completed by the end of the second quarter, 2008.
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According to the American Journal of Dermatology, retinoic acid isprescribed most often as the topical treatment of choice for acne. However,it is poorly soluble, is associated with irritation and dryness of the skinand, in some cases, can cause liver damage when substantial amounts enter thesystemic circulation. Irritation, though, is the most common adverse effectand is observed in approximately 90% of users. Additionally, according to TheAmerican Dermatological Association Inc., half of the patients who end theirretinoic acid treatment cycle prematurely do so because of irritation.Consequently, practitioners are often reluctant to prescribe retinoic acid inlarge quantities and, typically, marketed formulations contain between only0.025% and 0.1% of the active, which often serves to dilute the effectivenessof retinoic acid. Despite this, the U.S. market for topical prescriptionretinoids, such as retinoic acid, for acne treatment exceeds US$300 millionannually.
"A new formulation with the ability to deliver greater absorption ofretinoic acid, reduce irritation and dryness and limit systemic circulationwould significantly increase practitioners' flexibility in prescribing theproduct," said Harry Rosen, President & CEO of Phosphagenics. "It wouldenable physicians to prescribe greater doses of retinoic acid and/or maintaincurrent dosing while achieving improved efficacy and substantially limitingadverse effects. Such a product would have the potential to expand thecurrent market, and would likely capture a significant proportion of theexisting market.
"In our previously completed pre-clinical studies, we were able toconsistently demonstrate an increase in retinoic acid delivered, a reductionin irritation scores, as well as limit the delivery of retinoic acid into thesystemic circulation, which is important because of its side effects. Ourobjective is to replicate these results in our human trial and deliver asafer, more effective acne treatment to consumers as quickly as possible."
In addition to retinoic acid, Phosphagenics is developing a number ofother product candidates utilizing its targeted, non-systemic deliverytechnology, including multiple anti-inflammatory and analgesic compounds.
About Phosphagenics Limited
Phosphagenics is a Melbourne-based, globally driven biotechnology companyfocused on the discovery of new and cost effective ways to enhance thebioavailability, activity, safety and delivery of proven pharmaceutical andnutraceutical products.
Phosphagenics' core technology is built around the science and applicationof phosphorylation, a process where the addition of a phosphate group has beenfound to enhance the bioavailability, activity and safety of existingpharmaceuticals and nutraceuticals, as well a
