Phosphagenics Announces Successful Phase 1 Transdermal Oxycodone Clinical Trial Results

Dec 17, 2007, 00:00 ET from Phosphagenics Limited

    MELBOURNE, Australia, Dec. 17 /PRNewswire-FirstCall/ -- Phosphagenics
 Limited ("Phosphagenics") (ASX: POH, AIM: PSG, OTCQX: PPGNY) today
 announced positive results of its Phase 1 clinical trial that showed its
 delivery technology, TPM, delivered leading pain-relief drug oxycodone
 through the skin without causing disruption or irritation of any kind.
     These results support Phosphagenics' aims to be the first company to
 commercialize a sustained release oxycodone patch for the management of
 chronic pain.
     "Oxycodone, with worldwide annual sales of more than $1 billion, is
 more potent than morphine with fewer adverse effects; however, oxycodone is
 not available transdermally due to serious issues relating to skin
 sensitization and irritation," said Dr. Esra Ogru, Executive Vice President
 of Research and Development at Phosphagenics. "Our trial results show that
 TPM can deliver oxycodone through the skin in a sustained release
 formulation without causing skin irritation."
     This trial, which was conducted by CMAX (an independent clinical
 research organization located at the Royal Adelaide Hospital) was a
 single-centre, single-blinded, pharmacokinetic trial in 16 healthy
 subjects. The trial endpoints were to evaluate the safety and tolerability
 of the TPM/Oxycodone formulation and the ability of the TPM technology to
 deliver oxycodone into the body.
     The oxycodone, administered as a single transdermal application, was
 safe with no adverse events reported. Oxycodone was detected in the
 subjects for at least 48 hours. The results demonstrate that the
 formulation is bioavailable and effective in delivering oxycodone into the
     A collaborative program is now under way with a world leading patch
 development company to incorporate the current formulation into a patch
 system. Plans are also underway to undertake a pivotal clinical study in
 the first half of 2008.
     "Developing our pain relief pipeline builds on the success of
 Phosphagenics' previous transdermal clinical trials and provides a platform
 for the development of many other products," added Dr. Ogru.
     Mr. Harry Rosen, President and CEO of Phosphagenics, said: "Completing
 this Phase 1 trial was an important milestone for our pain management
 program. We are delighted to have successfully completed this trial and
 look forward to progressing to the next phase."
     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.

SOURCE Phosphagenics Limited