Phosphagenics Initiates U.S. Clinical Trials for Its Topical Retinoic Acid

Feb 19, 2008, 00:00 ET from Phosphagenics Limited

    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 retinoic acid. Despite this,
 the U.S. market for topical prescription retinoids, such as retinoic acid,
 for acne treatment exceeds US$300 million annually.
     "A new formulation with the ability to deliver greater absorption of
 retinoic acid, reduce irritation and dryness and limit systemic circulation
 would significantly increase practitioners' flexibility in prescribing the
 product," said Harry Rosen, President & CEO of Phosphagenics. "It would
 enable physicians to prescribe greater doses of retinoic acid and/or
 maintain current dosing while achieving improved efficacy and substantially
 limiting adverse effects. Such a product would have the potential to expand
 the current market, and would likely capture a significant proportion of
 the existing market.
     "In our previously completed pre-clinical studies, we were able to
 consistently demonstrate an increase in retinoic acid delivered, a
 reduction in irritation scores, as well as limit the delivery of retinoic
 acid into the systemic circulation, which is important because of its side
 effects. Our objective is to replicate these results in our human trial and
 deliver a safer, more effective acne treatment to consumers as quickly as
     In addition to retinoic acid, Phosphagenics is developing a number of
 other product candidates utilizing its targeted, non-systemic delivery
 technology, including multiple anti-inflammatory and analgesic compounds.
     About Phosphagenics Limited
     Phosphagenics is a Melbourne-based, globally driven biotechnology
 company focused on the discovery of new and cost effective ways to enhance
 the bioavailability, activity, safety and delivery of proven pharmaceutical
 and nutraceutical products.
     Phosphagenics' core technology is built around the science and
 application of phosphorylation, a process where the addition of a phosphate
 group has been found to enhance the bioavailability, activity and safety of
 existing pharmaceuticals and nutraceuticals, as well as to assist in the
 production of drug delivery platforms.
     Phosphagenics' shares are listed on the Australian Stock Exchange (POH)
 and the London Stock Exchange's Alternative Investment Market (PSG). An ADR
 - Level 1 program was established in the U.S. with The Bank of New York
 Mellon (PPGNY) for U.S. investors to trade in Phosphagenics' stock on the
 'over-the-counter' market. In July 2007, this was upgraded to the
 International OTCQX, a new premium market tier in the U.S. for
 international exchange-listed companies, operated by Pink Sheets, LLC.
     For more information, please visit Phosphagenics' web site at
     Safe Harbor Statement
     This press release contains forward-looking statements based on current
 expectations of future events. If underlying assumptions prove inaccurate
 or unknown risks or uncertainties materialise, actual results could vary
 materially from the Phosphagenics' expectations and projections. Risks and
 uncertainties include general industry conditions and competition; economic
 conditions, such as interest rate and currency exchange rate fluctuations;
 technological advances and patents attained by competitors; challenges
 inherent in new product development, including obtaining regulatory
 approvals; domestic and foreign health care reforms and governmental laws
 and regulations.
Company Contact Details: U.S. Investor and Media Contacts: Harry Rosen Brian Ritchie Phosphagenics Limited Financial Dynamics President and CEO Tel +1 212 850 5683 Tel +61 3 9605 5900 Mary McSwiggan Phosphagenics Limited Investor Relations Manager Tel +61 3 9605 5907

SOURCE Phosphagenics Limited