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Phosphagenics Initiates U.S. Clinical Trials for Its Topical Retinoic Acid
Date:2/19/2008

MELBOURNE, Australia, Feb. 19 /PRNewswire-FirstCall/ -- Phosphagenics Limited ("Phosphagenics") (ASX: POH; AIM: PSG; OTCQX: PPGNY) today announced the initiation of a human clinical trial for its lead dermatological product, retinoic acid, a form of vitamin A. This trial represents the Company's first clinical trial to take place in the U.S. and denotes the commencement of the Company's planned expansion into targeted, non-systemic delivery of drugs.

This trial follows a number of pre-clinical studies that demonstrated both an increase in dermal absorption of retinoic acid when formulated with Phosphagenics' proprietary drug delivery platform (TPM), and a significant reduction in irritation scores. The clinical trial is a double blinded study that will involve 90 subjects and is being conducted at Broomall, PA-based cyberDERM Inc., a contract research organization focused on developing and refining innovative bio-instrumental and computerized methods for non-invasive analysis 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.

According to the American Journal of Dermatology, retinoic acid is prescribed most often as the topical treatment of choice for acne. However, it is poorly soluble, is associated with irritation and dryness of the skin and, in some cases, can cause liver damage when substantial amounts enter the systemic circulation. Irritation, though, is the most common adverse effect and is observed in approximately 90% of users. Additionally, according to The American Dermatological Association Inc., half of the patients who end their retinoic acid treatment cycle prematurely do so because of irritation. Consequently, practitioners are often reluctant to prescribe retinoic acid in large quantities and, typically, marketed formulations contain between only 0.025% and 0.1% of the active, which often serves to dilute the effectiveness of retinoi
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SOURCE Phosphagenics Limited
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