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
"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
SOURCE Phosphagenics Limited