Phosphagenics Ltd Announce Successful Transdermal Oxycodone Clinical Trial Results

Main Category: Pain / Anesthetics
Also Included In: Clinical Trials / Drug Trials
Article Date: 17 Dec 2007 - 2:00 PDT

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Phosphagenics Limited ("Phosphagenics") (ASX: POH) (AIM: PSG) (OTCQX: PPGNY) 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 any disruption or irritation.

Dr Esra Ogru, Executive Vice President of Research and Development at Phosphagenics, said these results support Phosphagenics' aims to be the first to commercialise a sustainedrelease oxycodone patch for the management of chronic pain.

"Oxycodone, with worldwide annual sales of more than $US 1 billion, is more potent than morphine with fewer adverse effects; however, oxycodone is not available transdermally due to serious issues relating to skin sensitisation and irritation," Dr Ogru said.

"Our trial results show that TPM can deliver oxycodone through the skin in a sustainedrelease formulation without causing skin irritation."

This trial, which was conducted by CMAX (an independent clinical research organisation 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 body.

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.

Dr Esra Ogru said that developing its pain relief pipeline builds on the success of previous transdermal clinical trials and provides a platform for the development of many other products.

Mr Harry Rosen, President and CEO 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.

Phosphagenics Limited