ann - out

30 June 2010
Company Announcement
PHOSPHAGENICS: PAIN PATCH TECHNOLOGY MOVES
FORWARD
Further trial of TPM transdermal technology
Melbourne biotechnology company Phosphagenics Limited (ASX: POH; OTCQX: PPGNY)
continues to move ahead with the development of its pain patch, a new way of delivering
the commonly used painkiller oxycodone. Oxycodone, an opioid, is one of the worlds
leading pain management drugs with worldwide sales exceeding US$3 billion annually.
In a previously conducted pharmacokinetic study involving the daily administration of a patch
to healthy volunteers, Phosphagenics demonstrated that its TPM/oxycodone patch delivered
therapeutic levels of oxycodone to healthy volunteers over a number of days.
The company is announcing the commencement of the next phase of clinical development
for its proprietary system which uses TPM technology to deliver pain relief transdermally,
that is, through the skin.
Chief Executive Officer, Dr Esra Ogru, said recruitment has begun for the next stage clinical
trial which is designed to identify the dosing parameters best suited for use in the upcoming
Phase II/III clinical trial.
The current trial of the revolutionary oxycodone delivery system is being conducted at the
Royal Adelaide Hospital under the guidance of Principal Investigator Professor Guy
Ludbrook, Professor of Anaesthesia at the University of Adelaide.
This trial is designed to establish the optimal duration that the TPM/Oxycodone patch should
be left on a patient, as well as the optimal dose of oxycodone required in a patch to provide
pain relief. The study will compare the daily application of TPM/Oxycodone patches of
different oxycodone doses as well as comparing the daily-applied patches to patches applied
once per week.
Each subject will be administered with TPM/oxycodone patches for 14 days either daily or
once per week. Oxycodone levels in the blood will be used to assess which dosing regime
and duration of application has the most favourable therapeutic profile with respect to
oxycodone delivery and duration of action.
The results of this trial will determine which patch dose and application method will be best
suited for commercial development. The best candidate will be advanced into Phase II/III
oxycodone clinical trials scheduled for 2010/2011.
Dr Ogru said the Company was working closely with an international pain advisory board and
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regulatory consultants, and had mapped out a clear path forward for the development and
commercialisation of this product.
Phosphagenics Vice President R&D, Dr Paul Gavin, said the TPM/oxycodone patch system
appeared to be very suitable for chronic pain management.
The results of our TPM/oxycodone trials last year impressed global opinion-leaders in the
field of pain management and generated significant commercial interest, he said.
Our TPM patch system clearly has the potential to change the way in which chronic pain
could be treated in the future.
Dr Gavin said that although the patches used in the initial clinical trial may turn out to be
optimal, product-profiling of the patch was a necessary step in designing the Phase II/III
efficacy study and is critical for our overall program.
If we can reduce the oxycodone dose or increase the patch duration, this would offer
significant regulatory advantages and commercial outcomes, he said.

Cheers JMMC