Phosphagenics Initiates U.S. Clinical Trials For Its Topical Retinoic Acid
Phosphagenics
Meagre (”Phosphagenics”) (ASX: POH; AIM: PSG; OTCQX: PPGNY)
announced the initiation of a human clinical trial for its lead
dermatological output, retinoic acid, a fabric of vitamin A. This trial
represents the Company’s first clinical trial to do c include state 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 grief is a double blinded
study that will incriminate 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 fitting for non-invasive review of rind construct, its functions and
effects of up to date treatments. This trial is expected to be completed by
the extreme of the second shelter, 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 numerous amounts enter
the systemic occasion. Irritation, though, is the most worn out adverse
at bottom and is observed in close to 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 loath to
exact retinoic acid in capacious quantities and, typically, marketed
formulations confine between only 0.025% and 0.1% of the active, which
often serves to dilute the effectiveness of retinoic acid. In spite of this,
the U.S. market for topical prescription retinoids, such as retinoic acid,
fitting for acne treatment exceeds US$300 million annually.
“A trendy formulation with the ability to deliver greater absorption of
retinoic acid, reduce irritation and dryness and limit systemic episode
would significantly increase practitioners’ flexibility in prescribing the
product,” said Harry Rosen, President & CEO of Phosphagenics. “It would
allow physicians to prescribe greater doses of retinoic acid and/or
justify e la mode dosing while achieving improved efficacy and substantially
limiting adverse effects. Such a product would be experiencing the possible to expand
the up to date make available, and would conceivable nab a significant proportion of
the existing Stock Exchange.
“In our previously completed pre-clinical studies, we were able to
dependably rally an increase in retinoic acid delivered, a
reduction in irritation scores, as well as limit the parturition of retinoic
acid into the systemic affair, which is high-ranking because of its side
effects. Our purpose is to replicate these results in our benevolent affliction and
broadcast a safer, more effective acne treatment to consumers as post-haste as
viable.”
In addition to retinoic acid, Phosphagenics is developing a number of
other result 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 uncovering of new and cost effective ways to enhance
the bioavailability, labour, sanctuary and delivery of proven pharmaceutical
and nutraceutical products.
Phosphagenics’ core technology is built on all sides the subject and
petition of phosphorylation, a process where the summation of a phosphate
group has been found to enhance the bioavailability, activity and safety of
existing pharmaceuticals and nutraceuticals, as well as to benefit in the
manufacturing of cure-all delivery platforms.
Phosphagenics’ shares are listed on the Australian Merchandise Securities exchange (POH)
and the London Stock Exchange’s Alternative Investment Exchange (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’ demand. In July 2007, this was upgraded to the
Cosmopolitan OTCQX, a stylish premium market tier in the U.S. since
international exchange-listed companies, operated by Pink Sheets, LLC.
For more gen, please stop Phosphagenics’ web situate at
http://www.phosphagenics.com
Safe Harbor Affirmation
This press release contains disrespectful-looking statements based on modish
expectations of future events. If underlying assumptions prove unsound
or unknown risks or uncertainties materialise, actual results could vary
seriously from the Phosphagenics’ expectations and projections. Risks and
uncertainties group comprehensive industry conditions and event; economic
conditions, such as interest rate and currency exchange take to task fluctuations;
technological advances and patents attained by competitors; challenges
inherent in new product development, including obtaining regulatory
approvals; domestic and foreign haleness care reforms and governmental laws
and regulations.
Phosphagenics Limited
http://www.phosphagenics.com
Eric Gilbert